Home/CFR/Title 21/Part 862
FEDERAL · 21 CFR

Part 862 — Clinical Chemistry and Clinical Toxicology Devices

261 sections · Title 21: Food and Drugs

§ 862.1Scope.
§ 862.2Regulation of calibrators.
§ 862.3Effective dates of requirement for premarket approval.
§ 862.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 862.1020Acid phosphatase (total or prostatic) test system.
§ 862.1025Adrenocorticotropic hormone (ACTH) test system.
§ 862.1030Alanine amino transferase (ALT/SGPT) test system.
§ 862.1035Albumin test system.
§ 862.1040Aldolase test system.
§ 862.1045Aldosterone test system.
§ 862.1050Alkaline phosphatase or isoenzymes test system.
§ 862.1055Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
§ 862.1060Delta-aminolevulinic acid test system.
§ 862.1065Ammonia test system.
§ 862.1070Amylase test system.
§ 862.1075Androstenedione test system.
§ 862.1080Androsterone test system.
§ 862.1085Angiotensin I and renin test system.
§ 862.1090Angiotensin converting enzyme (A.C.E.) test system.
§ 862.1092Anti-mullerian hormone test system.
§ 862.1093Menopause test system.
§ 862.1095Ascorbic acid test system.
§ 862.1100Aspartate amino transferase (AST/SGOT) test system.
§ 862.1110Bilirubin (total or direct) test system.
§ 862.1113Bilirubin (total and unbound) in the neonate test system.
§ 862.1115Urinary bilirubin and its conjugates (nonquantitative) test system.
§ 862.1117B-type natriuretic peptide test system.
§ 862.1118Biotinidase test system.
§ 862.1120Blood gases (P<sub>CO2</sub>, P<sub>O2</sub>) and blood pH test system.
§ 862.1130Blood volume test system.
§ 862.1135C-peptides of proinsulin test system.
§ 862.1140Calcitonin test system.
§ 862.1145Calcium test system.
§ 862.1150Calibrator.
§ 862.1155Human chorionic gonadotropin (HCG) test system.
§ 862.1160Bicarbonate/carbon dioxide test system.
§ 862.1163Cardiac allograft gene expression profiling test system.
§ 862.1164Setmelanotide eligibility gene variant detection system.
§ 862.1165Catecholamines (total) test system.
§ 862.1170Chloride test system.
§ 862.1175Cholesterol (total) test system.
§ 862.1177Cholylglycine test system.
§ 862.1180Chymotrypsin test system.
§ 862.1185Compound S (11-deoxycortisol) test system.
§ 862.1187Conjugated sulfolithocholic acid (SLCG) test system.
§ 862.1190Copper test system.
§ 862.1195Corticoids test system.
§ 862.1200Corticosterone test system.
§ 862.1205Cortisol (hydrocortisone and hydroxycorticosterone) test system.
§ 862.1210Creatine test system.
§ 862.1215Creatine phosphokinase/creatine kinase or isoenzymes test system.
§ 862.1220Acute kidney injury test system.
§ 862.1225Creatinine test system.
§ 862.1230Cyclic AMP test system.
§ 862.1235Cyclosporine test system.
§ 862.1240Cystine test system.
§ 862.1245Dehydroepiandrosterone (free and sulfate) test system.
§ 862.1250Desoxycorticosterone test system.
§ 862.12552,3-Diphosphoglyceric acid test system.
§ 862.1260Estradiol test system.
§ 862.1265Estriol test system.
§ 862.1270Estrogens (total, in pregnancy) test system.
§ 862.1275Estrogens (total, nonpregnancy) test system.
§ 862.1280Estrone test system.
§ 862.1285Etiocholanolone test system.
§ 862.1290Fatty acids test system.
§ 862.1295Folic acid test system.
§ 862.1300Follicle-stimulating hormone test system.
§ 862.1305Formiminoglutamic acid (FIGLU) test system.
§ 862.1310Galactose test system.
§ 862.1315Galactose-1-phosphate uridyl transferase test system.
§ 862.1320Gastric acidity test system.
§ 862.1325Gastrin test system.
§ 862.1330Globulin test system.
§ 862.1335Glucagon test system.
§ 862.1340Urinary glucose (nonquantitative) test system.
§ 862.1345Glucose test system.
§ 862.1350Continuous glucose monitor secondary alarm system.
§ 862.1355Integrated continuous glucose monitoring system.
§ 862.1356Interoperable automated glycemic controller.
§ 862.1358Insulin therapy adjustment device.
§ 862.1360Gamma-glutamyl transpeptidase and isoenzymes test system.
§ 862.1365Glutathione test system.
§ 862.1370Human growth hormone test system.
§ 862.1373Hemoglobin A1c test system.
§ 862.1375Histidine test system.
§ 862.1377Urinary homocystine (nonquantitative) test system.
§ 862.1380Hydroxybutyric dehydrogenase test system.
§ 862.138517-Hydroxycorticosteroids (17-ketogenic steroids) test system.
§ 862.13905-Hydroxyindole acetic acid/serotonin test system.
§ 862.139517-Hydroxyprogesterone test system.
§ 862.1400Hydroxyproline test system.
§ 862.1405Immunoreactive insulin test system.
§ 862.1410Iron (non-heme) test system.
§ 862.1415Iron-binding capacity test system.
§ 862.1420Isocitric dehydrogenase test system.
§ 862.143017-Ketosteroids test system.
§ 862.1435Ketones (nonquantitative) test system.
§ 862.1440Lactate dehydrogenase test system.
§ 862.1445Lactate dehydrogenase isoenzymes test system.
§ 862.1450Lactic acid test system.
§ 862.1455Lecithin/sphingomyelin ratio in amniotic fluid test system.
§ 862.1460Leucine aminopeptidase test system.
§ 862.1465Lipase test system.
§ 862.1470Lipid (total) test system.
§ 862.1475Lipoprotein test system.
§ 862.1485Luteinizing hormone test system.
§ 862.1488Lysosomal storage disorder newborn screening test system.
§ 862.1490Lysozyme (muramidase) test system.
§ 862.1493Breast milk macronutrients test system.
§ 862.1495Magnesium test system.
§ 862.1500Malic dehydrogenase test system.
§ 862.1505Mucopolysaccharides (nonquantitative) test system.
§ 862.1506Muscular dystrophy newborn screening test.
§ 862.1509Methylmalonic acid (nonquantitative) test system.
§ 862.1510Nitrite (nonquantitative) test system.
§ 862.1515Nitrogen (amino-nitrogen) test system.
§ 862.15205′-Nucleotidase test system.
§ 862.1530Plasma oncometry test system.
§ 862.1535Ornithine carbamyl transferase test system.
§ 862.1540Osmolality test system.
§ 862.1542Oxalate test system.
§ 862.1545Parathyroid hormone test system.
§ 862.1550Urinary pH (nonquantitative) test system.
§ 862.1555Phenylalanine test system.
§ 862.1560Urinary phenylketones (nonquantitative) test system.
§ 862.15656-Phosphogluconate dehydrogenase test system.
§ 862.1570Phosphohexose isomerase test system.
§ 862.1575Phospholipid test system.
§ 862.1580Phosphorus (inorganic) test system.
§ 862.1585Human placental lactogen test system.
§ 862.1590Porphobilinogen test system.
§ 862.1595Porphyrins test system.
§ 862.1600Potassium test system.
§ 862.1602Prognostic test for development or progression of preeclampsia.
§ 862.1605Pregnanediol test system.
§ 862.1610Pregnanetriol test system.
§ 862.1615Pregnenolone test system.
§ 862.1620Progesterone test system.
§ 862.1622Prognostic test for assessment of liver related disease progression.
§ 862.1625Prolactin (lactogen) test system.
§ 862.1630Protein (fractionation) test system.
§ 862.1635Total protein test system.
§ 862.1640Protein-bound iodine test system.
§ 862.1645Urinary protein or albumin (nonquantitative) test system.
§ 862.1650Pyruvate kinase test system.
§ 862.1655Pyruvic acid test system.
§ 862.1660Quality control material (assayed and unassayed).
§ 862.1665Sodium test system.
§ 862.1670Sorbitol dehydrogenase test system.
§ 862.1675Blood specimen collection device.
§ 862.1676Blood collection device for cell-free nucleic acids.
§ 862.1678Tacrolimus test system.
§ 862.1680Testosterone test system.
§ 862.1685Thyroxine-binding globulin test system.
§ 862.1690Thyroid stimulating hormone test system.
§ 862.1695Free thyroxine test system.
§ 862.1700Total thyroxine test system.
§ 862.1705Triglyceride test system.
§ 862.1710Total triiodothyronine test system.
§ 862.1715Triiodothyronine uptake test system.
§ 862.1720Triose phosphate isomerase test system.
§ 862.1725Trypsin test system.
§ 862.1730Free tyrosine test system.
§ 862.1770Urea nitrogen test system.
§ 862.1775Uric acid test system.
§ 862.1780Urinary calculi (stones) test system.
§ 862.1785Urinary urobilinogen (nonquantitative) test system.
§ 862.1790Uroporphyrin test system.
§ 862.1795Vanilmandelic acid test system.
§ 862.1805Vitamin A test system.
§ 862.1810Vitamin B<sub>12</sub> test system.
§ 862.1815Vitamin E test system.
§ 862.1820Xylose test system.
§ 862.1825Vitamin D test system.
§ 862.1840Total 25-hydroxyvitamin D mass spectrometry test system.
§ 862.2050General purpose laboratory equipment labeled or promoted for a specific medical use.
§ 862.2100Calculator/data processing module for clinical use.
§ 862.2120Continuous glucose monitor data management system.
§ 862.2140Centrifugal chemistry analyzer for clinical use.
§ 862.2150Continuous flow sequential multiple chemistry analyzer for clinical use.
§ 862.2160Discrete photometric chemistry analyzer for clinical use.
§ 862.2170Micro chemistry analyzer for clinical use.
§ 862.2230Chromatographic separation material for clinical use.
§ 862.2250Gas liquid chromatography system for clinical use.
§ 862.2260High pressure liquid chromatography system for clinical use.
§ 862.2265High throughput genomic sequence analyzer for clinical use.
§ 862.2270Thin-layer chromatography system for clinical use.
§ 862.2300Colorimeter, photometer, or spectrophotometer for clinical use.
§ 862.2310Clinical sample concentrator.
§ 862.2320Beta or gamma counter for clinical use.
§ 862.2400Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
§ 862.2485Electrophoresis apparatus for clinical use.
§ 862.2500Enzyme analyzer for clinical use.
§ 862.2540Flame emission photometer for clinical use.
§ 862.2560Fluorometer for clinical use.
§ 862.2570Instrumentation for clinical multiplex test systems.
§ 862.2680Microtitrator for clinical use.
§ 862.2700Nephelometer for clinical use.
§ 862.2720Plasma oncometer for clinical use.
§ 862.2730Osmometer for clinical use.
§ 862.2750Pipetting and diluting system for clinical use.
§ 862.2800Refractometer for clinical use.
§ 862.2850Atomic absorption spectrophotometer for clinical use.
§ 862.2860Mass spectrometer for clinical use.
§ 862.2900Automated urinalysis system.
§ 862.2920Plasma viscometer for clinical use.
§ 862.3030Acetaminophen test system.
§ 862.3035Amikacin test system.
§ 862.3040Alcohol test system.
§ 862.3050Breath-alcohol test system.
§ 862.3080Breath nitric oxide test system.
§ 862.3100Amphetamine test system.
§ 862.3110Antimony test system.
§ 862.3120Arsenic test system.
§ 862.3150Barbiturate test system.
§ 862.3170Benzodiazepine test system.
§ 862.3200Clinical toxicology calibrator.
§ 862.3220Carbon monoxide test system.
§ 862.3240Cholinesterase test system.
§ 862.3245Clozapine test system.
§ 862.3250Cocaine and cocaine metabolite test system.
§ 862.3270Codeine test system.
§ 862.3280Clinical toxicology control material.
§ 862.3300Digitoxin test system.
§ 862.3320Digoxin test system.
§ 862.3350Diphenylhydantoin test system.
§ 862.3360Drug metabolizing enzyme genotyping system.
§ 862.3364Pharmacogenetic assessment system.
§ 862.3380Ethosuximide test system.
§ 862.3450Gentamicin test system.
§ 862.3460Plazomicin test system.
§ 862.3520Kanamycin test system.
§ 862.3550Lead test system.
§ 862.3555Lidocaine test system.
§ 862.3560Lithium test system.
§ 862.3580Lysergic acid diethylamide (LSD) test system.
§ 862.3590Meprobamate test system.
§ 862.3600Mercury test system.
§ 862.3610Methamphetamine test system.
§ 862.3620Methadone test system.
§ 862.3630Methaqualone test system.
§ 862.3640Morphine test system.
§ 862.3645Neuroleptic drugs radioreceptor assay test system.
§ 862.3650Opiate test system.
§ 862.3652Organophosphate test system.
§ 862.3660Phenobarbital test system.
§ 862.3670Phenothiazine test system.
§ 862.3680Primidone test system.
§ 862.3700Propoxyphene test system.
§ 862.3750Quinine test system.
§ 862.3800Reagents for molecular diagnostic instrument test systems.
§ 862.3830Salicylate test system.
§ 862.3840Sirolimus test system.
§ 862.3850Sulfonamide test system.
§ 862.3870Cannabinoid test system.
§ 862.3880Theophylline test system.
§ 862.3900Tobramycin test system.
§ 862.3910Tricyclic antidepressant drugs test system.
§ 862.3950Vancomycin test system.
§ 862.3970Voriconazole test system.