21 CFR Part 862 — Clinical Chemistry and Clinical Toxicology Devices

PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 52 FR 16122, May 1, 1987, unless otherwise noted. Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required in § 807.87. (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. (d) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. [52 FR 16122, May 1, 1987, as amended at 67 FR 58329, Sept. 16, 2002; 78 FR 18233, Mar. 26, 2013; 79 FR 50552, Aug. 25, 2014] § 862.2 Regulation of calibrators. Many devices classified in this part are intended to be used with a calibrator. A calibrator has a reference value assigned to it which serves as the basis by which test results of patients are derived or calculated. The calibrator for a device may be (a) manufactured and distributed separately from the device with which it is intended to be used, (b) manufactured and distributed as one of several device components, such as in a kit of reagents, or (c) built-in as an integral part of the device. Because of the central role that a calibrator plays in the measurement process and the critical effect calibrators have on accuracy of test results, elsewhere in this part, all three of these types of calibrators (§§ 862.1150 and 862.3200 of this part) are classified into class II, notwithstanding the classification of the device with which it is intended to be used. Thus, a device and its calibrator may have different classifications, even if the calibrator is built into the device. § 862.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. § 862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2304, Jan. 14, 2000] Subpart B—Clinical Chemistry Test Systems § 862.1020 Acid phosphatase (total or prostatic) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] § 862.1025 Adrenocorticotropic hormone (ACTH) test system. (a) Identification. (b) Classification. § 862.1030 Alanine amino transferase (ALT/SGPT) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1035 Albumin test system. (a) Identification. (b) Classification. § 862.1040 Aldolase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1045 Aldosterone test system. (a) Identification. (b) Classification. § 862.1050 Alkaline phosphatase or isoenzymes test system. (a) Identification. (b) Classification. § 862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry. (a) Identification. (b) Classification. [69 FR 68255, Nov. 24, 2004] § 862.1060 Delta-aminolevulinic acid test system. (a) Identification. delta delta Delta delta (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1065 Ammonia test system. (a) Identification. (b) Classification. § 862.1070 Amylase test system. (a) Identification. (b) Classification. § 862.1075 Androstenedione test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1080 Androsterone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1085 Angiotensin I and renin test system. (a) Identification. (b) Classification. § 862.1090 Angiotensin converting enzyme (A.C.E.) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] § 862.1092 Anti-mullerian hormone test system. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) An adequate traceability plan to minimize the risk of drift in anti-mullerian hormone test system results over time. (ii) Detailed documentation of a prospective clinical study to demonstrate clinical performance or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information: (A) Results must demonstrate adequate clinical performance relative to a well-accepted comparator. (B) Clinical sample results must demonstrate consistency of device output throughout the device measuring range that is appropriate for the intended use population. (C) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the proposed indications for use(s), and results of all statistical analyses. (iii) Reference intervals generated by testing an adequate number of samples from apparently healthy normal individuals in the intended use population. (2) The labeling required under § 809.10(b) of this chapter must include a warning statement that the device is intended to be used for assessing the ovarian reserve in conjunction with other clinical and laboratory findings before starting any fertility therapy, and that the device should be used in conjunction with the antral follicle count. [90 FR 22850, May 30, 2025] § 862.1093 Menopause test system. (a) Identification. (b) Classification. (1) Design verification and validation must include the following: (i) An appropriate traceability plan to minimize the risk of drift in the menopause test system results over time. (ii) Detailed documentation of a clinical study to demonstrate clinical performance or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information: (A) Results must demonstrate appropriate clinical performance relative to a well-accepted and appropriate comparator. (B) Data must demonstrate accuracy of device output for each indicated specimen type throughout the device measuring range as appropriate for the intended use population. (2) The labeling required under § 809.10 of this chapter must include the following: (i) A statement in the indications for use that the device is intended to be used for the determination of menopausal status only in conjunction with other clinical and laboratory findings prior to any diagnostic or treatment decisions. (ii) A limiting statement that the device is intended to be used for the determination of menopausal status only in conjunction with other clinical and laboratory findings prior to any diagnostic or treatment decisions. (iii) A limiting statement appropriately describing the risks of false test results and that test results should not be relied upon in clinical decision making ( e.g., [90 FR 40708, Aug. 21, 2025] § 862.1095 Ascorbic acid test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1100 Aspartate amino transferase (AST/SGOT) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] § 862.1110 Bilirubin (total or direct) test system. (a) Identification. (b) Classification. § 862.1113 Bilirubin (total and unbound) in the neonate test system. (a) Identification. (b) Classification. [54 FR 30206, July 19, 1989] § 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1117 B-type natriuretic peptide test system. (a) Identification. (b) Classification. [66 FR 12734, Feb. 28, 2001] § 862.1118 Biotinidase test system. (a) Identification. (b) Classification. [65 FR 16521, Mar. 29, 2000] § 862.1120 Blood gases (P CO2 O2 (a) Identification. CO2 O2 CO2 O2 (b) Classification. § 862.1130 Blood volume test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1135 C-peptides of proinsulin test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1140 Calcitonin test system. (a) Identification. (b) Classification. § 862.1145 Calcium test system. (a) Identification. (b) Classification. § 862.1150 Calibrator. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] § 862.1155 Human chorionic gonadotropin (HCG) test system. (a) Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy Identification. (2) Classification. (b) Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy Identification. (2) Classification. (3) Date PMA or notice of completion of a PDP is required. § 862.1160 Bicarbonate/carbon dioxide test system. (a) Identification. (b) Classification. § 862.1163 Cardiac allograft gene expression profiling test system. (a) Identification. (b) Classification. [74 FR 53885, Oct. 21, 2009] § 862.1164 Setmelanotide eligibility gene variant detection system. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) Detailed documentation of studies that provide data bridging the efficacy of setmelanotide in the clinical trial patient population identified by the clinical trial assay(s) to the efficacy of setmelanotide in the device intended use population identified by the device using the clinical trial samples, or through an alternative approach determined to be appropriate by FDA. (ii) Detailed documentation of studies that provide data demonstrating the accuracy of the device using clinical specimens representing the intended use specimen type(s) and intended use variant type(s) from the intended use population, including the clinical trial samples, or through an alternative approach determined to be appropriate by FDA. Accuracy of the device must be evaluated at the variant level and sample level, through evaluation of variant and non-variant sequences at the nucleotide level as well as variant interpretation, by comparison to validated bidirectional Sanger sequencing methods or through other methods determined to be appropriate by FDA. If the device will be used at more than one site, the data must demonstrate accuracy across multiple intended use sites. (iii) Detailed documentation of studies that provide data demonstrating the precision of the device for the intended use specimen type(s) and intended use variant type(s) from the intended use population. Precision must be evaluated at the variant level and sample level, through evaluation of variant and non-variant sequences at the nucleotide level as well as variant interpretation, using multiple reagent lots, operators, and instruments over multiple days, or through an alternative precision study design determined to be appropriate by FDA. If the device will be used at more than one site, data must demonstrate adequate, as determined by FDA, reproducibility across multiple intended use sites. (iv) Detailed documentation of studies that provide data demonstrating the analytical specificity of the device for the intended use specimen type(s), including an evaluation of cross-reactivity and cross contamination. (A) Cross-reactivity ( e.g., (B) Cross-contamination must be evaluated to detect carryover and co-mingling of input specimens throughout the process ( e.g., (v) Detailed documentation of studies that provide data demonstrating adequate, as determined by FDA, stability of the specimens used in the design validation studies in paragraphs (b)(1)(i) through (iv) of this section, as applicable. (vi) Detailed documentation of information demonstrating adequate, as determined by FDA, analytical quality metrics and thresholds. (vii) Detailed documentation of information demonstrating adequate, as determined by FDA, procedures that will be performed for variant interpretation and classification, including the procedures that will be performed for variant interpretation and classification changes that may occur as new scientific information becomes available. The information must indicate how the personnel performing such interpretation and classification are trained. (2) The labeling required under § 809.10(b) of this chapter and any test report generated must include: (i) Limiting statements that: (A) Explain that the classification and interpretation of variants identified reflects the current state of scientific understanding at the time the results are issued. (B) Explain variants could change classification as new scientific information becomes available, which may impact patient eligibility for therapeutic treatment; and (C) If applicable, explain sufficient scientific information is not available to assign pathogenicity to variants of uncertain significance (VUS). (ii) A detailed summary of the performance testing, including results, required under paragraphs (b)(1)(i) through (iv) of this section. [91 FR 21378, Apr. 22, 2026] § 862.1165 Catecholamines (total) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1170 Chloride test system. (a) Identification. (b) Classification. § 862.1175 Cholesterol (total) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1177 Cholylglycine test system. (a) Identification. (b) Classification. § 862.1180 Chymotrypsin test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1185 Compound S (11-deoxycortisol) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1187 Conjugated sulfolithocholic acid (SLCG) test system. (a) Identification. (b) Classification. § 862.1190 Copper test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] § 862.1195 Corticoids test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1200 Corticosterone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system. (a) Identification. (b) Classification. § 862.1210 Creatine test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] § 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system. (a) Identification. (b) Classification. § 862.1220 Acute kidney injury test system. (a) Identification. (b) Classification. (1) Premarket notification submissions must detail an appropriate end user device training program that will be offered while marketing the device as part of your efforts to mitigate the risk of incorrect interpretation of test results. (2) As part of the risk management activities performed as part of your 21 CFR 820.10(c) design and development activities, you must document the appropriate end user device training program provided in your premarket notification submission to satisfy the special control in paragraph (b)(1) of this section that will be offered while marketing the device as part of your efforts to mitigate the risk of incorrect interpretation of test results. (3) Robust clinical data demonstrating the positive predictive value, negative predictive value, sensitivity and specificity of the test in the intended use population must be submitted as part of the premarket notification submission. [82 FR 50072, Oct. 30, 2017, as amended at 90 FR 55980, Dec. 4, 2025] § 862.1223 Prognostic test for assessment of chronic kidney disease progression. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) Detailed documentation of a clinical study that includes the following: (A) Information that demonstrates the clinical performance of the device in a population of patients with chronic kidney disease at the different reported risk categories for progression of their disease ( e.g., (B) Information that demonstrates the measured outcomes and the length of follow-up are clinically relevant to demonstrate the progression of the chronic kidney disease; and (C) A description of subjects from the target population ( e.g., (ii) Detailed documentation of a reference interval study that includes: (A) Data generated in samples from healthy individuals; and (B) Estimation of the upper and lower limits of the reference intervals and percentages of healthy individuals in each device-identified risk category. (iii) When appropriate, detailed information that demonstrates the precision of the numeric values of the device output (score) based on the precision profiles of each individual input. (iv) When appropriate, detailed information on the impact of the cumulative effect of potential interferents on the numeric values of the device output (score) based on the information known or determined for the potential of interference for each individual input. (2) The labeling required under § 809.10(b) of this chapter must include: (i) Limiting statements indicating that: (A) The test results are not intended to diagnose any disease or condition; (B) The test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including information obtained by alternative methods, and clinical evaluation, as appropriate; and (C) The device is not intended for serial monitoring of kidney disease progression or for monitoring the effect of any therapeutic product. (ii) Limiting statements, where applicable, describing the limitations on the clinical interpretations of the test results. (iii) Limiting statements, where applicable, describing the limitations to the data generated in the clinical study(ies). (iv) Detailed information on device performance in relevant subgroups ( e.g., [91 FR 46715, July 24, 2026] § 862.1225 Creatinine test system. (a) Identification. (b) Classification. § 862.1230 Cyclic AMP test system. (a) Identification. (b) Classification. § 862.1235 Cyclosporine test system. (a) Identification. (b) Classification. [67 FR 58329, Sept. 16, 2002] § 862.1240 Cystine test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1245 Dehydroepiandrosterone (free and sulfate) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1250 Desoxycorticosterone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1255 2,3-Diphosphoglyceric acid test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] § 862.1260 Estradiol test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1265 Estriol test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1270 Estrogens (total, in pregnancy) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1275 Estrogens (total, nonpregnancy) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1280 Estrone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1285 Etiocholanolone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1290 Fatty acids test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] § 862.1295 Folic acid test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988] § 862.1300 Follicle-stimulating hormone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1305 Formiminoglutamic acid (FIGLU) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] § 862.1310 Galactose test system. (a) Identification. (b) Classification. § 862.1315 Galactose-1-phosphate uridyl transferase test system. (a) Identification. (b) Classification. § 862.1320 Gastric acidity test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] § 862.1325 Gastrin test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1330 Globulin test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1335 Glucagon test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1340 Urinary glucose (nonquantitative) test system. (a) Identification. (b) Classification. § 862.1345 Glucose test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019; 85 FR 18445, Apr. 2, 2020] § 862.1350 Continuous glucose monitor secondary alarm system. (a) Identification. (b) Classification. (1) Devices being marketed must include appropriate measures to protect against unauthorized access to data and unauthorized modification of data. (2) The labeling must prominently and conspicuously display a warning that states “Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system.” (3) The labeling for the device must include a statement that reads “This device is not intended to replace self-monitoring practices as advised by a physician.” [82 FR 13550, Mar. 14, 2017, as amended at 84 FR 71796, Dec. 30, 2019; 86 FR 20283, Apr. 19, 2021] § 862.1355 Integrated continuous glucose monitoring system. (a) Identification. (b) Classification. (1) Design verification and validation must include the following: (i) Robust clinical data demonstrating the accuracy of the device in the intended use population. (ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order ( e.g., (iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device. (iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period. (v) Clinical study results in the adult population must meet the following performance requirements: (A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent. (B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent. (C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent. (D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent. (E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent. (F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent. (G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent. (H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL. (I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL. (J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements. (K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements. (vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate. (vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use. (2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data. (3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section. (4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications. (5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period. (6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy. (7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites ( e.g., (i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL. (ii) A description of the accuracy of positive and negative rate of change data. (iii) A description of the frequency and duration of gaps in sensor data. (iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable. (v) A description of the observed duration of iCGM life for the device. [87 FR 9238, Feb. 18, 2022] § 862.1356 Interoperable automated glycemic controller. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use. (A) The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use. (B) For devices indicated for use with multiple therapeutic agents for the same therapeutic effect ( e.g., (C) When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events. (ii) Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use. (iii) A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices. (iv) Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to ( e.g., e.g., (v) Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices. (vi) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( e.g., e.g., (vii) A detailed plan and procedure for assigning postmarket responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller. (2) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following: (i) Risk control measures to address device system hazards; (ii) Design decisions related to how the risk control measures impact essential performance; and (iii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design. (3) The device shall include appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following: (i) Secure authentication (pairing) to connected devices; (ii) Secure, accurate, and reliable means of data transmission between the controller and connected devices; (iii) Sharing of necessary state information between the controller and any connected devices ( e.g., (iv) Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified; (v) A detailed process and procedures for sharing the controller's interface specification with connected devices and for validating the correct implementation of that protocol; and (vi) A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance. (4) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices, and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the controller must, at a minimum, include: (i) Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices; (ii) Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices ( e.g., (iii) Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and (iv) Connectivity events ( e.g., (5) The device must only receive glucose input from devices cleared under § 862.1355 (integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section. (6) The device must only command drug delivery from devices cleared under § 880.5730 of this chapter (alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section. (7) An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable. (8) The labeling required under § 809.10(b) of this chapter must include: (i) A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part. (ii) A prominent statement identifying any populations for which use of this device has been determined to be unsafe. (iii) A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate. (iv) The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (b)(1)(iii) of this section. (v) A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate. (vi) A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (b)(1)(i) of this section. (vii) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device. (viii) For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses. [87 FR 14172, Mar. 14, 2022] § 862.1358 Insulin therapy adjustment device. (a) Identification. (b) Classification. (1) Design verification and validation must include the following: (i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations; (ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated; (iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations; (iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification; (v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures; (vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and (vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level. (2) The device must not be intended for use in implementing automated insulin dosing. (3) Your 21 CFR 809.10(b) labeling must include: (i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device; (ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations; (iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and (iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel). [83 FR 54874, Nov. 1, 2018] § 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1365 Glutathione test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] § 862.1370 Human growth hormone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1373 Hemoglobin A1c test system. (a) Identification. (b) Classification. (1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA. (2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following: (i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable. (ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method. (iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent. (iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S. (3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations. [79 FR 50551, Aug. 25, 2014] § 862.1375 Histidine test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1377 Urinary homocystine (nonquantitative) test system. (a) Identification. (b) Classification. § 862.1380 Hydroxybutyric dehydrogenase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] § 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system. (a) Identification. moiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortisol, cortisone 11-desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of various diseases of the adrenal or pituitary glands and gonadal disorders. (b) Classification. [52 FR 16122, May 1, 1987; 52 FR 29468, Aug. 7, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1390 5-Hydroxyindole acetic acid/serotonin test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1395 17-Hydroxyprogesterone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1400 Hydroxyproline test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1405 Immunoreactive insulin test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1410 Iron (non-heme) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] § 862.1415 Iron-binding capacity test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] § 862.1420 Isocitric dehydrogenase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1430 17-Ketosteroids test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1435 Ketones (nonquantitative) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1440 Lactate dehydrogenase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 63 FR 59225, Nov. 3, 1998] § 862.1445 Lactate dehydrogenase isoenzymes test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] § 862.1450 Lactic acid test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system. (a) Identification. (b) Classification. § 862.1460 Leucine aminopeptidase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1465 Lipase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1470 Lipid (total) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1475 Lipoprotein test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1485 Luteinizing hormone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1488 Lysosomal storage disorder newborn screening test system. (a) Identification. (b) Classification. (1) Design verification and validation must include information that demonstrates the performance characteristics of the device, including: (i) Study results that adequately demonstrate the clinical validity of the device, which must include information supporting the link between the analyte being measured and the condition being screened. The clinical validity of the device must be demonstrated in a clinical validation study using either well-characterized prospectively or retrospectively obtained clinical specimens from the intended use population. Testing in the clinical validation study must be performed by operators representative of the types of operators intended to use the test. The study design of the clinical validation study must assess the effects of sample collection and processing steps on test performance. Confirmed positive specimens must have a diagnosis based on confirmatory diagnostic methods or clinically meaningful information regarding the status of the subject must be obtained. (ii) The reference interval in the normal newborn population for the analyte or analytes measured by the device. (iii) Study results demonstrating the level of carryover or drift affecting the device performance. (iv) Study results demonstrating the concentrations of the limit of blank, limit of detection, and limit of quantitation of the device. Sample concentrations below the limit of quantitation must not be reported by the device. (v) Study results, which must be collected using sample panels from at least three reagent lots and at least three instruments over more than 20 testing days, demonstrating the imprecision of the device. The sample panels must consist of blood spot specimens with a range of analyte concentrations that span the reportable range of the device and must include samples with concentrations in the screen positive range, samples with concentrations at each cutoff, and samples with concentration in the normal range. (2) The labeling required under § 809.10(b) of this chapter must include: (i) A warning that indicates that the test is not intended to diagnose lysosomal storage disorders. (ii) A warning that indicates that test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, and clinical evaluation as appropriate. (iii) Detailed information on device performance, including the false positive rate and the false negative rate observed in the clinical study. (iv) Information on device performance in any relevant subgroup ( e.g., [90 FR 27230, June 26, 2025] § 862.1490 Lysozyme (muramidase) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1493 Breast milk macronutrients test system. (a) Identification. (b) Classification. (1) Design verification and validation must include the following: (i) An appropriate traceability plan, as determined by FDA, to minimize the risk of drift in the breast milk macronutrient test system results over time. (ii) Data that demonstrate appropriate precision, as determined by FDA, of the breast milk macronutrients test system. Precision studies must include assessment of a minimum of three breast milk specimens containing different concentrations (low, medium, and high levels) of fat, carbohydrates, and protein. Precision data must include breast milk specimen measurements that are collected at a minimum of three laboratory sites. (iii) Data that demonstrate appropriate measurement accuracy, as determined by FDA, of fat, carbohydrates, and protein in breast milk. Measurement accuracy data must include breast milk specimen measurements that are collected at a minimum of one laboratory site. (iv) Data from studies appropriate, as determined by FDA, to demonstrate that the device is free from significant interference from substances that could be present in human milk, including hemoglobin, and medications that are used by breastfeeding subjects. (2) The labeling required under § 809.10 of this chapter must include a limiting statement indicating that the results should be used only as an aid in the nutritional management of infants and not as the sole basis for making nutrition decisions. [90 FR 19628, May 9, 2025] § 862.1495 Magnesium test system. (a) Identification. (b) Classification. § 862.1500 Malic dehydrogenase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1505 Mucopolysaccharides (nonquantitative) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1506 Muscular dystrophy newborn screening test. (a) Identification. (b) Classification. (1) Design verification and validation must include a clinical validation study that includes the following: (i) Results that demonstrate that the analyte being measured identifies a population of newborns who should be subject to follow up diagnostic testing for the condition being screened. (ii) Predictive value of the device demonstrated using either well characterized prospectively or retrospectively obtained clinical specimens from the intended use population. (iii) Testing performed by device users who are representative of the types of operators intended to use the test. (iv) A design that assesses the effects of sample collection and processing steps on test performance. (v) Tested confirmed positive specimens must have associated diagnostic outcome information based on confirmatory diagnostic methods, or clinically meaningful information regarding the status of the subject must be obtained. (vi) Data, provided or referenced, generated in samples from the intended use population, that demonstrates the upper reference interval(s), including sufficient samples to calculate the 97.5th and 99.5th percentile information, for the analyte or analytes measured by the device. (2) The labeling required under § 809.10(b) of this chapter must include: (i) A warning which states that test results are not intended to diagnose muscular dystrophies. (ii) A warning which states that test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, and clinical evaluation as appropriate. (iii) Detailed information on device performance, including the false positive screen rate and the false negative screen rate observed in the clinical study, and any limitations to the data generated in the clinical study ( e.g., (iv) Information on device performance in relevant subgroups ( e.g., [90 FR 27228, June 26, 2025] § 862.1509 Methylmalonic acid (nonquantitative) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] § 862.1510 Nitrite (nonquantitative) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1515 Nitrogen (amino-nitrogen) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1520 5′-Nucleotidase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1530 Plasma oncometry test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1535 Ornithine carbamyl transferase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1540 Osmolality test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1542 Oxalate test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1545 Parathyroid hormone test system. (a) Identification. (b) Classification. § 862.1550 Urinary pH (nonquantitative) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1555 Phenylalanine test system. (a) Identification. (b) Classification. § 862.1560 Urinary phenylketones (nonquantitative) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1565 6-Phosphogluconate dehydrogenase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1570 Phosphohexose isomerase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1575 Phospholipid test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1580 Phosphorus (inorganic) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] § 862.1585 Human placental lactogen test system. (a) Identification. (b) Classification. § 862.1590 Porphobilinogen test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1595 Porphyrins test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1600 Potassium test system. (a) Identification. (b) Classification. § 862.1602 Prognostic test for development or progression of preeclampsia. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) Detailed documentation of a study that demonstrates the clinical performance of the device for its intended use, evaluated across multiple intended use sites and broad demographics representative of intended use patients in the United States; or through an alternative approach determined to be appropriate by FDA; (ii) Detailed documentation of studies that demonstrate the analytical performance of the device for its intended use, including for each analyte and device output. These studies must include precision, reproducibility, metrological accuracy, and analytical specificity studies, or alternative approaches determined to be appropriate by FDA; and (iii) As part of the risk management activities, documentation of an appropriate licensed practitioner training program on the proper use of the device and proper interpretation of results that must be offered to licensed practitioners, or an alternative approach determined to be appropriate by FDA. (2) The labeling required under § 809.10(b) of this chapter must include: (i) Detailed descriptions of the device studies demonstrating the performance of the device, including results; and (ii) Limiting statements including the following: (A) The test result is intended as an aid in the management of the patient, and not to be used to replace clinical judgement. (B) The test result is not to be used to aid in the diagnosis of preeclampsia or conditions resulting from progression of preeclampsia. (C) The test result is not to be used to aid in decisions of hospital discharge. (D) The test result is not to be used to aid in decisions of pregnancy delivery. (E) The test is not intended to inform the healthcare provider about whether or not changes in immediate treatment, including medication or hospitalization, are needed. [91 FR 38497, June 26, 2026] § 862.1605 Pregnanediol test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1610 Pregnanetriol test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1615 Pregnenolone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1620 Progesterone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1622 Prognostic test for assessment of liver related disease progression. (a) Identification. (b) Classification. (1) Design verification and validation must include clinical validation data providing: (i) Information demonstrating clinical performance in a population of patients with liver disease for the different risk categories ( e.g., (ii) Information demonstrating that the outcomes measured and the length of followup are clinically relevant for the progression of the specified liver disease. (iii) Information demonstrating that the clinical criteria for determining whether the target disease is present and that the exclusion and inclusion criteria for subjects who have the target disease are appropriate. (iv) Information demonstrating test performance of the complete test system, including any sample collection and processing steps. (v) Information, provided or referenced, generated in samples from non-diseased individuals, that demonstrate the upper and lower reference intervals for the output provided by the device. (2) The labeling required under 21 CFR 809.10(b) must include: (i) A warning statement that test results are not intended to diagnose disease or for monitoring the effect of any therapeutic product. (ii) A warning statement that test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including information obtained by alternative methods, and clinical evaluation, as appropriate. (iii) A warning statement that describes any limitations on the clinical interpretation(s) of the test results. (iv) Detailed information on device performance, including any limitations to the data generated in the clinical study(ies) and information on device performance in relevant subgroups ( e.g., (v) Information on the analytical performance of the device, including demonstration of reproducibility across multiple sites and multiple reagent lots, or an alternative reproducibility study design determined to be appropriate by FDA. [88 FR 2519, Jan. 17, 2023] § 862.1625 Prolactin (lactogen) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1630 Protein (fractionation) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1635 Total protein test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 63 FR 59225, Nov. 3, 1998] § 862.1640 Protein-bound iodine test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1645 Urinary protein or albumin (nonquantitative) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1650 Pyruvate kinase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1655 Pyruvic acid test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1660 Quality control material (assayed and unassayed). (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000, 84 FR 71796, Dec. 30, 2019] § 862.1665 Sodium test system. (a) Identification. (b) Classification. § 862.1670 Sorbitol dehydrogenase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1675 Blood specimen collection device. (a) Identification. (b) Classification. § 862.1676 Blood collection device for cell-free nucleic acids. (a) Identification. (b) Classification. (1) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device for its intended use, including all of its indications for use, and must include the following: (i) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( e.g., (ii) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( e.g., (A) Data demonstrating that blood samples collected in the device have reproducible cell-free nucleic acid yields that are suitable, as determined by FDA, for downstream testing as appropriate for the intended use, including estimates of within-lot, within-device, and lot-to-lot variability; (B) Data demonstrating that cell-free nucleic acid yields isolated from blood specimens collected into the device do not add clinically significant bias to test results obtained using the downstream application(s) described in the intended use. For devices indicated for use with multiple downstream applications, data demonstrating acceptable performance for each type of claimed use or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed; (C) Data demonstrating that the device appropriately stabilizes cell-free nucleic acids after sample collection, during storage, and during transport over the claimed shelf life of the device; (D) Data demonstrating that samples collected in the device have minimal levels of contamination with other types of nucleic acids present in cells or cellular components, and that these levels of contamination do not interfere with downstream testing; (E) Data from analytical or clinical studies that demonstrate that, when used as intended, the device consistently draws a blood sample volume that is within the indicated fill range; (F) Data from analytical or clinical studies that demonstrate that, when used as intended, cell-free nucleic acid yield, stability, and quality are not significantly impacted by interference due to other parts of the device (such as reduced or excess active ingredient) or specimen collection and processing procedures (such as hemolysis, centrifugation, or mixing of blood with anticoagulant or additives); and (G) Data from analytical studies that demonstrate that the device is suitable for its intended use across all storage and sample handling conditions described in the device labeling, including device shelf life and shipping conditions ( e.g., (iii) A protocol, reviewed and determined acceptable by FDA, that specifies the verification and validation activities that will be performed for anticipated device modifications to reevaluate performance claims or performance specifications. This protocol must include a process for assessing whether a modification to technology, engineering, performance, materials, specifications, or indications for use, or any combination thereof, could significantly affect the safety or effectiveness of the device. The protocol must include assessment metrics, acceptance criteria, and analytical methods for the performance testing of changes. [89 FR 72983, Sept. 9, 2024] § 862.1678 Tacrolimus test system. (a) Identification. (b) Classification. [67 FR 58329, Sept. 16, 2002] § 862.1680 Testosterone test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988] § 862.1685 Thyroxine-binding globulin test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] § 862.1690 Thyroid stimulating hormone test system. (a) Identification. (b) Classification. § 862.1695 Free thyroxine test system. (a) Identification. (b) Classification. § 862.1700 Total thyroxine test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] § 862.1705 Triglyceride test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1710 Total triiodothyronine test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 62286, Oct. 18, 2000] § 862.1715 Triiodothyronine uptake test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 64 FR 1124, Jan. 8, 1999] § 862.1720 Triose phosphate isomerase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1725 Trypsin test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1730 Free tyrosine test system. (a) Identification. (b) Classification. § 862.1770 Urea nitrogen test system. (a) Identification. (b) Classification. § 862.1775 Uric acid test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019; 85 FR 18445, Apr. 2, 2020] § 862.1780 Urinary calculi (stones) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1785 Urinary urobilinogen (nonquantitative) test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1790 Uroporphyrin test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1795 Vanilmandelic acid test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1805 Vitamin A test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1810 Vitamin B 12 (a) Identification. 12 12 (b) Classification. § 862.1815 Vitamin E test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1820 Xylose test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1825 Vitamin D test system. (a) Identification. (b) Classification. (1) Labeling in conformance with 21 CFR 809.10 and (2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards. [63 FR 40366, July 29, 1998] § 862.1840 Total 25-hydroxyvitamin D mass spectrometry test system. (a) Identification. (b) Classification. (1) The device must have initial and annual standardization verification by a certifying vitamin D standardization organization deemed acceptable by FDA. (2) The 21 CFR 809.10(b) compliant labeling must include detailed descriptions of performance testing conducted to evaluate precision, accuracy, linearity, interference, including the following: (i) Performance testing of device precision must, at a minimum, use intended sample type with Vitamin D concentrations at medically relevant decision points. At least one sample in the precision studies must be an unmodified patient sample. This testing must evaluate repeatability and reproducibility using a protocol from an FDA-recognized standard. (ii) Performance testing of device accuracy must include a minimum of 115 serum or plasma samples that span the measuring interval of the device and compare results of the new device to results of a reference method or a legally marketed standardized mass spectrometry based vitamin D assay. The results must be described in the 21 CFR 809.10(b)(12) compliant labeling of the device. (iii) Interference from vitamin D analogs and metabolites including vitamin D2, vitamin D3, 1-hydroxyvitamin D2, 1-hydroxyvitamin D3, 3-Epi-25-Hydroxyvitamin D2, 3-Epi-25-Hydroxyvitamin D3, 1,25-Dihydroxyvitamin D2, 1,25-Dihydroxyvitamin D3, 3-Epi-1,25-Dihydroxyvitamin D2, and 3-Epi-1,25-Dihydroxyvitamin D3, 25, 26-Dihydroxyvitamin-D3, 24 (R), 25-dihydroxyvitamin-D3, 23 (R), 25-dihydroxyvitamin-D3 must be described in the 21 CFR 809.10(b)(7) compliant labeling of the device. (3) The 21 CFR 809.10(b) compliant labeling must be supported by a reference range study representative of the performance of the device. The study must be conducted using samples collected from apparently healthy male and female adults at least 21 years of age and older from at least 3 distinct climatic regions within the United States in different weather seasons. The ethnic, racial, and gender background of this study population must be representative of the U.S. population demographics. (4) The results of the device as provided in the 21 CFR 809.10(b) compliant labeling and any test report generated must be reported as only total 25-hydroxyvitamin D. [82 FR 51559, Nov. 7, 2017, as amended at 83 FR 25914, June 5, 2018] Subpart C—Clinical Laboratory Instruments § 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 66 FR 38788, July 25, 2001; 90 FR 55980, Dec. 4, 2025] § 862.2100 Calculator/data processing module for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001; 86 FR 20283, Apr. 19, 2021] § 862.2120 Continuous glucose monitor data management system. (a) Identification. (b) Classification. [84 FR 57817, Oct. 29, 2019] § 862.2140 Centrifugal chemistry analyzer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.2160 Discrete photometric chemistry analyzer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2170 Micro chemistry analyzer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2230 Chromatographic separation material for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38788, July 25, 2001] § 862.2250 Gas liquid chromatography system for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2260 High pressure liquid chromatography system for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2265 High throughput genomic sequence analyzer for clinical use. (a) Identification. (b) Classification. (1) The labeling for the instrument system must reference legally marketed pre-analytical and analytical reagents to be used with the instrument system and include or reference legally marketed analytical software that includes sequence alignment and variant calling functions, to be used with the instrument system. (2) The labeling for the instrument system must include a description of the following information: (i) The specimen type(s) validated as an appropriate source of nucleic acid for this instrument. (ii) The type(s) of nucleic acids ( e.g., (iii) The type(s) of sequence variations ( e.g. (iv) The type(s) of sequencing ( e.g., (v) The appropriate read depth for the sensitivity claimed and validation information supporting those claims. (vi) The nucleic acid extraction method(s) validated for use with the instrument system. (vii) Limitations must specify the types of sequence variations that the instrument cannot detect with the claimed accuracy and precision ( e.g., (viii) Performance characteristics of the instrument system must include: (A) Reproducibility data generated using multiple instruments and multiple operators, and at multiple sites. Samples tested must include all claimed specimen types, nucleic acid types, sequence variation types, and types of sequencing. Variants queried shall be located in varying sequence context ( e.g., (B) Accuracy data for all claimed specimen types and nucleic acid types generated by testing a panel of well characterized samples to query all claimed sequence variation types, types of sequencing, and sequences located in varying sequence context ( e.g., (C) If applicable, data describing endogenous or exogenous substances that may interfere with the instrument system. (D) If applicable, data demonstrating the ability of the system to consistently generate an accurate result for a given sample across different indexing primer combinations. (ix) The upper and lower limit of input nucleic acid that will achieve the claimed accuracy and reproducibility. Data supporting such claims must also be summarized. [82 FR 13552, Mar. 14, 2017, as amended at 84 FR 71797, Dec. 30, 2019] § 862.2270 Thin-layer chromatography system for clinical use. (a) Identification. (b) Classification. i.e., [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000; 90 FR 55980, Dec. 4, 2025] § 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2310 Clinical sample concentrator. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 60 FR 38899, July 28, 1995; 66 FR 38788, July 25, 2001] § 862.2320 Beta or gamma counter for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38788, July 25, 2001] § 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2485 Electrophoresis apparatus for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38788, July 25, 2001] § 862.2500 Enzyme analyzer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2540 Flame emission photometer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2560 Fluorometer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2570 Instrumentation for clinical multiplex test systems. (a) Identification. (b) Classification. [70 FR 11868, Mar. 10, 2005, as amended at 84 FR 71797, Dec. 30, 2019] § 862.2680 Microtitrator for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2700 Nephelometer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2720 Plasma oncometer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38788, July 25, 2001] § 862.2730 Osmometer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2750 Pipetting and diluting system for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2800 Refractometer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38788, July 25, 2001] § 862.2850 Atomic absorption spectrophotometer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2860 Mass spectrometer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2900 Automated urinalysis system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2920 Plasma viscometer for clinical use. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38788, July 25, 2001] Subpart D—Clinical Toxicology Test Systems § 862.3030 Acetaminophen test system. (a) Identification. (b) Classification. § 862.3035 Amikacin test system. (a) Identification. (b) Classification. § 862.3040 Alcohol test system. (a) Identification. (b) Classification. § 862.3050 Breath-alcohol test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] § 862.3080 Breath nitric oxide test system. (a) Identification. (b) Classification. [68 FR 40127, July 7, 2003] § 862.3100 Amphetamine test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] § 862.3110 Antimony test system. (a) Identification. (b) Classification. § 862.3115 Anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease. (a) Identification. (b) Classification. (1) Design verification and validation must include the following: (i) Detailed documentation of studies that demonstrate the analytical performance of the device for its intended use, including for each analyte and device output. These studies must demonstrate analytical performance for each monoclonal antibody analyte and device output that is adequate to support all intended clinical uses, including all of its indications for use, and testing environments. These studies must include precision, reproducibility, linearity, accuracy, high dose hook effect, sample stability, detection limits (including limit of blank, limit of detection, and limit of quantification) and analytical specificity studies, or alternative approaches determined to be appropriate by FDA. (ii) Detailed documentation of data that is adequate to support the accuracy of the device and/or device performance for all intended clinical uses, including all of its indications for use, as determined to be appropriate by FDA. (iii) Detailed documentation demonstrating traceability of the device to an internationally recognized reference material, as determined to be appropriate by FDA. (2) The labeling required under § 809.10(b) of this chapter must include limiting statements including the following: (i) The device should not be used for conditions other than Crohn's disease or ulcerative colitis. (ii) The test result is intended as an aid in the management of the patient, and not to be used to replace clinical judgment. [91 FR 57495, Sept. 10, 2026] § 862.3120 Arsenic test system. (a) Identification. (b) Classification. § 862.3150 Barbiturate test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] § 862.3170 Benzodiazepine test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] § 862.3200 Clinical toxicology calibrator. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] § 862.3220 Carbon monoxide test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] § 862.3240 Cholinesterase test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] § 862.3245 Clozapine test system. (a) Identification. (b) Classification. (1) Design verification and validation must include the following: (i) Precision study data that demonstrates precision that is clinically appropriate, as determined by FDA, for the clozapine test system. Precision studies must include a minimum of three samples containing different concentrations of clozapine including near medical decision points and throughout the expected therapeutic range of clozapine. Samples near the medical decision points must be clinical specimens collected from patients taking clozapine; (ii) Method comparison data that demonstrates accuracy that is clinically acceptable, as determined by FDA, for the clozapine test system; (iii) Data from studies that demonstrate that the device is free from clinically significant interference, as determined by FDA, from commonly co-administered medications that are used in patients with treatment-resistant schizophrenia; and (iv) Data from studies that demonstrate that the device is free from clinically significant cross-reactivity, as determined by FDA, from major circulating metabolites found in the intended use population. (2) The labeling required under § 809.10 of this chapter must include a limiting statement conveying that the assay should only be used in conjunction with information available from clinical evaluations and other diagnostic procedures and that results from the assay alone should not be used in making treatment decisions. [89 FR 75491, Sept. 16, 2024] § 862.3250 Cocaine and cocaine metabolite test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] § 862.3270 Codeine test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019] § 862.3280 Clinical toxicology control material. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000, 84 FR 71798, Dec. 30, 2019] § 862.3300 Digitoxin test system. (a) Identification. (b) Classification. § 862.3320 Digoxin test system. (a) Identification. (b) Classification. § 862.3350 Diphenylhydantoin test system. (a) Identification. (b) Classification. § 862.3360 Drug metabolizing enzyme genotyping system. (a) Identification. (b) Classification. [70 FR 11867, Mar. 10, 2005] § 862.3364 Pharmacogenetic assessment system. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) Data appropriate, as determined by FDA, to demonstrate the analytical accuracy and reliability of the device in intended use specimens, including precision, reproducibility, accuracy, limits of detection, and interferences. This information must include: (A) Data demonstrating appropriate, as determined by FDA, reproducibility for each genotype using each claimed sample type. Reproducibility data must be evaluated using specimens collected and processed in a manner consistent with the device's instructions for use, or, as determined by FDA, an appropriate alternative sample panel. (B) Analytical data demonstrating the limits of detection, including the minimum amount of input deoxy-ribonucleic acid (DNA) that will consistently produce accurate results. (C) Data demonstrating no clinically significant effects from endogenous and exogenous interferents relevant to each intended use specimen type. Interference data must also include an assessment of potentially interfering genetic sequences ( e.g., (D) Validation data appropriate, as determined by FDA, to support specimen collection and handling claims. (E) Clinical data generated in intended use patient populations demonstrating the pharmacogenetic association between the genetic variant tested and any clinical claims or therapy-related recommendations associated with that genotype. (ii) Results from an appropriate, as determined by FDA, user comprehension study that demonstrate the intended user can use the device safely. The user comprehension study must be designed to include the following: (A) Study participants from a statistically sufficient sample size and a demographically diverse ( e.g., (B) An evaluation of all result comprehension concepts that are critical for safe use of the device. (2) The labeling required under § 809.10 of this chapter must include: (i) Clear information, written in language appropriate for the intended user, that describes instructions for how test results should be interpreted. These instructions must be supported by valid scientific evidence and include: (A) Appropriate explanation of the claimed pharmacogenetic associations for all variants included in the test, any relevant variants not included in the test ( e.g., (B) Appropriate explanation of non-genetic and non-tested genetic factors that may impact interpretation of the test results; (ii) Detailed descriptions of analytical performance including, as applicable, precision, reproducibility, accuracy, limits of detection, and interferences as specified in paragraph (b)(1)(i) of this section, in language appropriate for the intended user; (iii) A warning statement that the patient should not use the test results to stop or change any medication, and that medications should always be taken as prescribed by a healthcare professional; (iv) A limiting statement explaining that this test is not intended to inform the patient about their current state of health, including whether the patient should or should not take a medication, or how much of a medication the patient should take, as appropriate; (v) A warning statement that the test does not diagnose any health conditions and is not a substitute for visits to a doctor or other healthcare professional; and (vi) A prominent and conspicuous limiting statement that the test provides only a preliminary test result that needs to be confirmed using an independent pharmacogenetic test without such a limitation prior to making any medical decisions. Alternatively, appropriate design verification and validation activities, including the generation of robust analytical data demonstrating appropriate analytical accuracy and reliability of test results for each genetic variant included in the test report, must be performed that demonstrate that the test can be used to make well-informed clinical decisions. (3) The test report must include an appropriate description of how the test results should be used by healthcare providers who may receive the test results from their patients, as applicable. (4) Publicly available pre-purchase labeling with unrestricted access that contains the following information must be provided: (i) A clear description of the test and its technology, the genotypes detected, and relevant clinical claims associated with each genotype; (ii) A clear description of what information the test will provide. This includes variant information, the limitations associated with the test, and any precautionary information about the test the user should be aware of before purchase; and (iii) A discussion of answers to frequently asked questions that is sufficient to provide intended users with an appropriate understanding of information specific to each pharmacogenetic association that is claimed. (5) The genetic test must use a sample collection device that is FDA-cleared or -approved, or classified as 510(k) exempt, with an indication for in vitro diagnostic use in DNA testing. (6) The intended use of the device must not include an indication for use in supporting or sustaining human life, being of substantial importance in preventing impairment of human health, or presenting a potential, unreasonable risk of illness or injury. [90 FR 40706, Aug. 21, 2025] § 862.3380 Ethosuximide test system. (a) Identification. (b) Classification. § 862.3450 Gentamicin test system. (a) Identification. (b) Classification. § 862.3460 Plazomicin test system. (a) Identification. (b) Classification. (1) Design verification and validation must include the following: (i) Precision study data that demonstrates clinically appropriate precision of the plazomicin test system. Precision studies must include a minimum of three samples containing different concentrations of plazomicin, including near medical decision points throughout the expected therapeutic range of plazomicin. Samples near the medical decision points must be clinical specimens collected from patients taking plazomicin. (ii) Method comparison data that demonstrates clinically appropriate accuracy of the plazomicin test system, as determined by FDA. Method comparison data must be collected at a minimum of three laboratory sites. (iii) Data from studies appropriate to demonstrate that the device is free from clinically significant interference from co-administered medications that are used in patients with complicated urinary tract infection, as determined by FDA. (2) The device's labeling required under § 809.10 of this chapter must include a warning statement that explains: “This assay should only be used in conjunction with information available from clinical evaluations and other diagnostic procedures.” [90 FR 22629, May 29, 2025] § 862.3520 Kanamycin test system. (a) Identification. (b) Classification. § 862.3550 Lead test system. (a) Identification. (b) Classification. § 862.3555 Lidocaine test system. (a) Identification. (b) Classification. § 862.3560 Lithium test system. (a) Identification. (b) Classification. § 862.3580 Lysergic acid diethylamide (LSD) test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019] § 862.3590 Meprobamate test system. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) Robust data demonstrating the accuracy of the device when used in the intended specimen matrix. The accuracy data must include a comparison between the meprobamate test system results and meprobamate results that are measured on an FDA-accepted measurement method that is specific and accurate (e.g., gas or liquid chromatography combined with tandem mass spectrometry). (ii) Robust analytical data demonstrating the performance characteristics of the device, including, but not limited to, specificity, cross-reactivity to relevant endogenous and exogenous substances, and the reproducibility of analyte detection around the cutoff(s). (2) The intended use of the device must not include an indication for use in monitoring therapeutic drug concentrations or informing dosing adjustment decisions. (3) Your 21 CFR 809.10 labeling must include the following: (i) If indicated for use as a screening test to identify preliminary results for further confirmation, the intended use must state “This assay provides only a preliminary analytical result. A more specific alternative chemical confirmatory method (e.g., gas or liquid chromatography and mass spectrometry) must be used to obtain a confirmed analytical result. Clinical consideration and professional judgment must be exercised with any drug of abuse test, particularly when the preliminary test result is positive.” (ii) A limiting statement that reads as follows: “This test should not be used to monitor therapeutic drug concentrations or to inform dosing adjustment decisions.” [83 FR 54876, Nov. 1, 2018] § 862.3600 Mercury test system. (a) Identification. (b) Classification. § 862.3610 Methamphetamine test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019] § 862.3620 Methadone test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019] § 862.3630 Methaqualone test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019] § 862.3640 Morphine test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019] § 862.3645 Neuroleptic drugs radioreceptor assay test system. (a) Identification. (b) Classification. § 862.3650 Opiate test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019] § 862.3652 Organophosphate test system. (a) Identification. (b) Classification. (1) The distribution of these devices is limited to laboratories with experienced personnel who are trained to measure and evaluate organophosphate exposure and guide public health response. (2) Analytical testing must demonstrate the device has appropriate performance characteristics, including adequate precision and accuracy across the measuring range and near medical decision points. [82 FR 48415, Oct. 18, 2017] § 862.3660 Phenobarbital test system. (a) Identification. (b) Classification. § 862.3670 Phenothiazine test system. (a) Identification. (b) Classification. § 862.3680 Primidone test system. (a) Identification. (b) Classification. § 862.3700 Propoxyphene test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019] § 862.3750 Quinine test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988; 65 FR 2310, Jan. 14, 2000] § 862.3800 Reagents for molecular diagnostic instrument test systems. (a) Identification. (b) Classification. [82 FR 61163, Dec. 27, 2017] § 862.3830 Salicylate test system. (a) Identification. (b) Classification. § 862.3840 Sirolimus test system. (a) Identification. (b) Classification. [69 FR 58259, Sept. 30, 2004] § 862.3850 Sulfonamide test system. (a) Identification. (b) Classification. [52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988; 65 FR 2310, Jan. 14, 2000] § 862.3870 Cannabinoid test system. (a) Identification. delta (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71799, Dec. 30, 2019] § 862.3880 Theophylline test system. (a) Identification. (b) Classification. § 862.3900 Tobramycin test system. (a) Identification. (b) Classification. § 862.3910 Tricyclic antidepressant drugs test system. (a) Identification. (b) Classification. e.g., [52 FR 16122, May 1, 1987, as amended at 84 FR 71799, Dec. 30, 2019] § 862.3950 Vancomycin test system. (a) Identification. (b) Classification. § 862.3970 Voriconazole test system. (a) Identification. (b) Classification. (1) Design verification and validation must include the following information: (i) Data demonstrating the precision of the voriconazole test system. Precision studies must include a minimum of three samples containing different concentrations of voriconazole, including near medical decision points at the high and low end of the expected therapeutic range. Samples with concentrations near medical decision points must be individual or pooled clinical specimens, collected from patients taking voriconazole. (ii) Method comparison data demonstrating accuracy of the voriconazole test system. Method comparison data must be collected at three laboratory sites. The comparator method must not be subject to bias due to nonspecific detection of voriconazole. (iii) Data from interference studies performed to evaluate potential interference from co-administered medications used for conditions in which voriconazole is indicated. (iv) Data from studies performed to evaluate cross reactivity of the major metabolite, N-oxide voriconazole. (2) The labeling required under § 809.10(b) of this chapter must include a warning statement as follows: “This assay should only be used in conjunction with information available from clinical evaluations and other diagnostic procedures.” [90 FR 19626, May 9, 2025]

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