Part 862 — Clinical Chemistry and Clinical Toxicology Devices
Current through Sep 8, 2026
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
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.
Sections
- § 862.1 Scope.
- § 862.2 Regulation of calibrators.
- § 862.3 Effective dates of requirement for premarket approval.
- § 862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- § 862.1020 Acid phosphatase (total or prostatic) test system.
- § 862.1025 Adrenocorticotropic hormone (ACTH) test system.
- § 862.1030 Alanine amino transferase (ALT/SGPT) test system.
- § 862.1035 Albumin test system.
- § 862.1040 Aldolase test system.
- § 862.1045 Aldosterone test system.
- § 862.1050 Alkaline phosphatase or isoenzymes test system.
- § 862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
- § 862.1060 Delta-aminolevulinic acid test system.
- § 862.1065 Ammonia test system.
- § 862.1070 Amylase test system.
- § 862.1075 Androstenedione test system.
- § 862.1080 Androsterone test system.
- § 862.1085 Angiotensin I and renin test system.
- § 862.1090 Angiotensin converting enzyme (A.C.E.) test system.
- § 862.1092 Anti-mullerian hormone test system.
- § 862.1093 Menopause test system.
- § 862.1095 Ascorbic acid test system.
- § 862.1100 Aspartate amino transferase (AST/SGOT) test system.
- § 862.1110 Bilirubin (total or direct) test system.
- § 862.1113 Bilirubin (total and unbound) in the neonate test system.
- § 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system.
- § 862.1117 B-type natriuretic peptide test system.
- § 862.1118 Biotinidase test system.
- § 862.1120 Blood gases (PCO2, PO2) and blood pH test system.
- § 862.1130 Blood volume test system.
- § 862.1135 C-peptides of proinsulin test system.
- § 862.1140 Calcitonin test system.
- § 862.1145 Calcium test system.
- § 862.1150 Calibrator.
- § 862.1155 Human chorionic gonadotropin (HCG) test system.
- § 862.1160 Bicarbonate/carbon dioxide test system.
- § 862.1163 Cardiac allograft gene expression profiling test system.
- § 862.1164 Setmelanotide eligibility gene variant detection system.
- § 862.1165 Catecholamines (total) test system.
- § 862.1170 Chloride test system.
- § 862.1175 Cholesterol (total) test system.
- § 862.1177 Cholylglycine test system.
- § 862.1180 Chymotrypsin test system.
- § 862.1185 Compound S (11-deoxycortisol) test system.
- § 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
- § 862.1190 Copper test system.
- § 862.1195 Corticoids test system.
- § 862.1200 Corticosterone test system.
- § 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
- § 862.1210 Creatine test system.
- § 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
- § 862.1220 Acute kidney injury test system.
- § 862.1223 Prognostic test for assessment of chronic kidney disease progression.
- § 862.1225 Creatinine test system.
- § 862.1230 Cyclic AMP test system.
- § 862.1235 Cyclosporine test system.
- § 862.1240 Cystine test system.
- § 862.1245 Dehydroepiandrosterone (free and sulfate) test system.
- § 862.1250 Desoxycorticosterone test system.
- § 862.1255 2,3-Diphosphoglyceric acid test system.
- § 862.1260 Estradiol test system.
- § 862.1265 Estriol test system.
- § 862.1270 Estrogens (total, in pregnancy) test system.
- § 862.1275 Estrogens (total, nonpregnancy) test system.
- § 862.1280 Estrone test system.
- § 862.1285 Etiocholanolone test system.
- § 862.1290 Fatty acids test system.
- § 862.1295 Folic acid test system.
- § 862.1300 Follicle-stimulating hormone test system.
- § 862.1305 Formiminoglutamic acid (FIGLU) test system.
- § 862.1310 Galactose test system.
- § 862.1315 Galactose-1-phosphate uridyl transferase test system.
- § 862.1320 Gastric acidity test system.
- § 862.1325 Gastrin test system.
- § 862.1330 Globulin test system.
- § 862.1335 Glucagon test system.
- § 862.1340 Urinary glucose (nonquantitative) test system.
- § 862.1345 Glucose test system.
- § 862.1350 Continuous glucose monitor secondary alarm system.
- § 862.1355 Integrated continuous glucose monitoring system.
- § 862.1356 Interoperable automated glycemic controller.
- § 862.1358 Insulin therapy adjustment device.
- § 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
- § 862.1365 Glutathione test system.
- § 862.1370 Human growth hormone test system.
- § 862.1373 Hemoglobin A1c test system.
- § 862.1375 Histidine test system.
- § 862.1377 Urinary homocystine (nonquantitative) test system.
- § 862.1380 Hydroxybutyric dehydrogenase test system.
- § 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
- § 862.1390 5-Hydroxyindole acetic acid/serotonin test system.
- § 862.1395 17-Hydroxyprogesterone test system.
- § 862.1400 Hydroxyproline test system.
- § 862.1405 Immunoreactive insulin test system.
- § 862.1410 Iron (non-heme) test system.
- § 862.1415 Iron-binding capacity test system.
- § 862.1420 Isocitric dehydrogenase test system.
- § 862.1430 17-Ketosteroids test system.
- § 862.1435 Ketones (nonquantitative) test system.
- § 862.1440 Lactate dehydrogenase test system.
- § 862.1445 Lactate dehydrogenase isoenzymes test system.
- § 862.1450 Lactic acid test system.
- § 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.
- § 862.1460 Leucine aminopeptidase test system.
- § 862.1465 Lipase test system.
- § 862.1470 Lipid (total) test system.
- § 862.1475 Lipoprotein test system.
- § 862.1485 Luteinizing hormone test system.
- § 862.1488 Lysosomal storage disorder newborn screening test system.
- § 862.1490 Lysozyme (muramidase) test system.
- § 862.1493 Breast milk macronutrients test system.
- § 862.1495 Magnesium test system.
- § 862.1500 Malic dehydrogenase test system.
- § 862.1505 Mucopolysaccharides (nonquantitative) test system.
- § 862.1506 Muscular dystrophy newborn screening test.
- § 862.1509 Methylmalonic acid (nonquantitative) test system.
- § 862.1510 Nitrite (nonquantitative) test system.
- § 862.1515 Nitrogen (amino-nitrogen) test system.
- § 862.1520 5′-Nucleotidase test system.
- § 862.1530 Plasma oncometry test system.
- § 862.1535 Ornithine carbamyl transferase test system.
- § 862.1540 Osmolality test system.
- § 862.1542 Oxalate test system.
- § 862.1545 Parathyroid hormone test system.
- § 862.1550 Urinary pH (nonquantitative) test system.
- § 862.1555 Phenylalanine test system.
- § 862.1560 Urinary phenylketones (nonquantitative) test system.
- § 862.1565 6-Phosphogluconate dehydrogenase test system.
- § 862.1570 Phosphohexose isomerase test system.
- § 862.1575 Phospholipid test system.
- § 862.1580 Phosphorus (inorganic) test system.
- § 862.1585 Human placental lactogen test system.
- § 862.1590 Porphobilinogen test system.
- § 862.1595 Porphyrins test system.
- § 862.1600 Potassium test system.
- § 862.1602 Prognostic test for development or progression of preeclampsia.
- § 862.1605 Pregnanediol test system.
- § 862.1610 Pregnanetriol test system.
- § 862.1615 Pregnenolone test system.
- § 862.1620 Progesterone test system.
- § 862.1622 Prognostic test for assessment of liver related disease progression.
- § 862.1625 Prolactin (lactogen) test system.
- § 862.1630 Protein (fractionation) test system.
- § 862.1635 Total protein test system.
- § 862.1640 Protein-bound iodine test system.
- § 862.1645 Urinary protein or albumin (nonquantitative) test system.
- § 862.1650 Pyruvate kinase test system.
- § 862.1655 Pyruvic acid test system.
- § 862.1660 Quality control material (assayed and unassayed).
- § 862.1665 Sodium test system.
- § 862.1670 Sorbitol dehydrogenase test system.
- § 862.1675 Blood specimen collection device.
- § 862.1676 Blood collection device for cell-free nucleic acids.
- § 862.1678 Tacrolimus test system.
- § 862.1680 Testosterone test system.
- § 862.1685 Thyroxine-binding globulin test system.
- § 862.1690 Thyroid stimulating hormone test system.
- § 862.1695 Free thyroxine test system.
- § 862.1700 Total thyroxine test system.
- § 862.1705 Triglyceride test system.
- § 862.1710 Total triiodothyronine test system.
- § 862.1715 Triiodothyronine uptake test system.
- § 862.1720 Triose phosphate isomerase test system.
- § 862.1725 Trypsin test system.
- § 862.1730 Free tyrosine test system.
- § 862.1770 Urea nitrogen test system.
- § 862.1775 Uric acid test system.
- § 862.1780 Urinary calculi (stones) test system.
- § 862.1785 Urinary urobilinogen (nonquantitative) test system.
- § 862.1790 Uroporphyrin test system.
- § 862.1795 Vanilmandelic acid test system.
- § 862.1805 Vitamin A test system.
- § 862.1810 Vitamin B12 test system.
- § 862.1815 Vitamin E test system.
- § 862.1820 Xylose test system.
- § 862.1825 Vitamin D test system.
- § 862.1840 Total 25-hydroxyvitamin D mass spectrometry test system.
- § 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
- § 862.2100 Calculator/data processing module for clinical use.
- § 862.2120 Continuous glucose monitor data management system.
- § 862.2140 Centrifugal chemistry analyzer for clinical use.
- § 862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use.
- § 862.2160 Discrete photometric chemistry analyzer for clinical use.
- § 862.2170 Micro chemistry analyzer for clinical use.
- § 862.2230 Chromatographic separation material for clinical use.
- § 862.2250 Gas liquid chromatography system for clinical use.
- § 862.2260 High pressure liquid chromatography system for clinical use.
- § 862.2265 High throughput genomic sequence analyzer for clinical use.
- § 862.2270 Thin-layer chromatography system for clinical use.
- § 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
- § 862.2310 Clinical sample concentrator.
- § 862.2320 Beta or gamma counter for clinical use.
- § 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
- § 862.2485 Electrophoresis apparatus for clinical use.
- § 862.2500 Enzyme analyzer for clinical use.
- § 862.2540 Flame emission photometer for clinical use.
- § 862.2560 Fluorometer for clinical use.
- § 862.2570 Instrumentation for clinical multiplex test systems.
- § 862.2680 Microtitrator for clinical use.
- § 862.2700 Nephelometer for clinical use.
- § 862.2720 Plasma oncometer for clinical use.
- § 862.2730 Osmometer for clinical use.
- § 862.2750 Pipetting and diluting system for clinical use.
- § 862.2800 Refractometer for clinical use.
- § 862.2850 Atomic absorption spectrophotometer for clinical use.
- § 862.2860 Mass spectrometer for clinical use.
- § 862.2900 Automated urinalysis system.
- § 862.2920 Plasma viscometer for clinical use.
- § 862.3030 Acetaminophen test system.
- § 862.3035 Amikacin test system.
- § 862.3040 Alcohol test system.
- § 862.3050 Breath-alcohol test system.
- § 862.3080 Breath nitric oxide test system.
- § 862.3100 Amphetamine test system.
- § 862.3110 Antimony test system.
- § 862.3115 Anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease.
- § 862.3120 Arsenic test system.
- § 862.3150 Barbiturate test system.
- § 862.3170 Benzodiazepine test system.
- § 862.3200 Clinical toxicology calibrator.
- § 862.3220 Carbon monoxide test system.
- § 862.3240 Cholinesterase test system.
- § 862.3245 Clozapine test system.
- § 862.3250 Cocaine and cocaine metabolite test system.
- § 862.3270 Codeine test system.
- § 862.3280 Clinical toxicology control material.
- § 862.3300 Digitoxin test system.
- § 862.3320 Digoxin test system.
- § 862.3350 Diphenylhydantoin test system.
- § 862.3360 Drug metabolizing enzyme genotyping system.
- § 862.3364 Pharmacogenetic assessment system.
- § 862.3380 Ethosuximide test system.
- § 862.3450 Gentamicin test system.
- § 862.3460 Plazomicin test system.
- § 862.3520 Kanamycin test system.
- § 862.3550 Lead test system.
- § 862.3555 Lidocaine test system.
- § 862.3560 Lithium test system.
- § 862.3580 Lysergic acid diethylamide (LSD) test system.
- § 862.3590 Meprobamate test system.
- § 862.3600 Mercury test system.
- § 862.3610 Methamphetamine test system.
- § 862.3620 Methadone test system.
- § 862.3630 Methaqualone test system.
- § 862.3640 Morphine test system.
- § 862.3645 Neuroleptic drugs radioreceptor assay test system.
- § 862.3650 Opiate test system.
- § 862.3652 Organophosphate test system.
- § 862.3660 Phenobarbital test system.
- § 862.3670 Phenothiazine test system.
- § 862.3680 Primidone test system.
- § 862.3700 Propoxyphene test system.
- § 862.3750 Quinine test system.
- § 862.3800 Reagents for molecular diagnostic instrument test systems.
- § 862.3830 Salicylate test system.
- § 862.3840 Sirolimus test system.
- § 862.3850 Sulfonamide test system.
- § 862.3870 Cannabinoid test system.
- § 862.3880 Theophylline test system.
- § 862.3900 Tobramycin test system.
- § 862.3910 Tricyclic antidepressant drugs test system.
- § 862.3950 Vancomycin test system.
- § 862.3970 Voriconazole test system.