21 CFR Part 862 — Clinical Chemistry and Clinical Toxicology Devices
Subpart A — General Provisions
Subpart B — Clinical Chemistry Test Systems
- § 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 (P<sub>CO2</sub>, P<sub>O2</sub>) 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.
- § 862.1165— 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.
- § 862.1225— 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.
- § 862.1605— 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 B<sub>12</sub> 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.
Subpart C — Clinical Laboratory Instruments
- § 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.
Subpart D — Clinical Toxicology Test Systems
- § 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.
- § 862.3120— 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.