标题 21--食品和药品
第一章--食品和药物管理局
卫生与公众服务
部 分章 H 分章 - 医疗器械
第862部分临床化学和临床毒理学设备
PART 862 | CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES |
Subpart A - General Provisions
§ 862.1 - Scope.
§ 862.2 - Regulation of calibrators.
§ 862.3 - Effective dates of requirement forpremarket approval.
§ 862.9 - Limitations of exemptions fromsection 510(k) of the Federal Food, Drug, and Cosmetic Act (theact).
Subpart B - Clinical Chemistry Test Systems
§ 862.1020 - Acid phosphatase (total orprostatic) 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 orisoenzymes test system.
§ 862.1055 - Newborn screening test systemfor amino acids, free carnitine, and acylcarnitines using tandemmass spectrometry.
§ 862.1060 - Delta-aminolevulinic acid testsystem.
§ 862.1065 - Ammonia test system.
§ 862.1070 - Amylase test system.
§ 862.1075 - Androstenedione testsystem.
§ 862.1080 - Androsterone test system.
§ 862.1085 - Angiotensin I and renin testsystem.
§ 862.1090 - Angiotensin converting enzyme(A.C.E.) 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 itsconjugates (nonquantitative) test system.
§ 862.1117 - B-type natriuretic peptide testsystem.
§ 862.1118 - Biotinidase test system.
§ 862.1120 - Blood gases (PCO2, PO2) andblood pH test system.
§ 862.1130 - Blood volume test system.
§ 862.1135 - C-peptides of proinsulin testsystem.
§ 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 testsystem.
§ 862.1163 - Cardiac allograft geneexpression profiling test system.
§ 862.1165 - Catecholamines (total) testsystem.
§ 862.1170 - Chloride test system.
§ 862.1175 - Cholesterol (total) testsystem.
§ 862.1177 - Cholylglycine test system.
§ 862.1180 - Chymotrypsin test system.
§ 862.1185 - Compound S (11-deoxycortisol)test system.
§ 862.1187 - Conjugated sulfolithocholicacid (SLCG) test system.
§ 862.1190 - Copper test system.
§ 862.1195 - Corticoids test system.
§ 862.1200 - Corticosterone test system.
§ 862.1205 - Cortisol (hydrocortisone andhydroxycorticosterone) test system.
§ 862.1210 - Creatine test system.
§ 862.1215 - Creatine phosphokinase/creatinekinase or isoenzymes test system.
§ 862.1220 - Acute kidney injury testsystem.
§ 862.1225 - Creatinine test system.
§ 862.1230 - Cyclic AMP test system.
§ 862.1235 - Cyclosporine test system.
§ 862.1240 - Cystine test system.
§ 862.1245 - Dehydroepiandrosterone (freeand sulfate) test system.
§ 862.1250 - Desoxycorticosterone testsystem.
§ 862.1255 - 2,3-Diphosphoglyceric acid testsystem.
§ 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 testsystem.
§ 862.1290 - Fatty acids test system.
§ 862.1295 - Folic acid test system.
§ 862.1300 - Follicle-stimulating hormonetest system.
§ 862.1305 - Formiminoglutamic acid (FIGLU)test system.
§ 862.1310 - Galactose test system.
§ 862.1315 - Galactose-1-phosphate uridyltransferase test system.
§ 862.1320 - Gastric acidity testsystem.
§ 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 monitorsecondary alarm system.
§ 862.1355 - Integrated continuous glucosemonitoring system.
§ 862.1356 - Interoperable automatedglycemic controller.
§ 862.1358 - Insulin therapy adjustmentdevice.
§ 862.1360 - Gamma-glutamyl transpeptidaseand isoenzymes test system.
§ 862.1365 - Glutathione test system.
§ 862.1370 - Human growth hormone testsystem.
§ 862.1373 - Hemoglobin A1c test system.
§ 862.1375 - Histidine test system.
§ 862.1377 - Urinary homocystine(nonquantitative) test system.
§ 862.1380 - Hydroxybutyric dehydrogenasetest system.
§ 862.1385 - 17-Hydroxycorticosteroids(17-ketogenic steroids) test system.
§ 862.1390 - 5-Hydroxyindole aceticacid/serotonin test system.
§ 862.1395 - 17-Hydroxyprogesterone testsystem.
§ 862.1400 - Hydroxyproline test system.
§ 862.1405 - Immunoreactive insulin testsystem.
§ 862.1410 - Iron (non-heme) testsystem.
§ 862.1415 - Iron-binding capacity testsystem.
§ 862.1420 - Isocitric dehydrogenase testsystem.
§ 862.1430 - 17-Ketosteroids testsystem.
§ 862.1435 - Ketones (nonquantitative) testsystem.
§ 862.1440 - Lactate dehydrogenase testsystem.
§ 862.1445 - Lactate dehydrogenaseisoenzymes test system.
§ 862.1450 - Lactic acid test system.
§ 862.1455 - Lecithin/sphingomyelin ratio inamniotic fluid test system.
§ 862.1460 - Leucine aminopeptidase testsystem.
§ 862.1465 - Lipase test system.
§ 862.1470 - Lipid (total) test system.
§ 862.1475 - Lipoprotein test system.
§ 862.1485 - Luteinizing hormone testsystem.
§ 862.1490 - Lysozyme (muramidase) testsystem.
§ 862.1495 - Magnesium test system.
§ 862.1500 - Malic dehydrogenase testsystem.
§ 862.1505 - Mucopolysaccharides(nonquantitative) test system.
§ 862.1509 - Methylmalonic acid(nonquantitative) test system.
§ 862.1510 - Nitrite (nonquantitative) testsystem.
§ 862.1515 - Nitrogen (amino-nitrogen) testsystem.
§ 862.1520 - 5'-Nucleotidase testsystem.
§ 862.1530 - Plasma oncometry testsystem.
§ 862.1535 - Ornithine carbamyl transferasetest system.
§ 862.1540 - Osmolality test system.
§ 862.1542 - Oxalate test system.
§ 862.1545 - Parathyroid hormone testsystem.
§ 862.1550 - Urinary pH (nonquantitative)test system.
§ 862.1555 - Phenylalanine test system.
§ 862.1560 - Urinary phenylketones(nonquantitative) test system.
§ 862.1565 - 6-Phosphogluconatedehydrogenase test system.
§ 862.1570 - Phosphohexose isomerase testsystem.
§ 862.1575 - Phospholipid test system.
§ 862.1580 - Phosphorus (inorganic) testsystem.
§ 862.1585 - Human placental lactogen testsystem.
§ 862.1590 - Porphobilinogen testsystem.
§ 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 assessmentof liver related disease progression.
§ 862.1625 - Prolactin (lactogen) testsystem.
§ 862.1630 - Protein (fractionation) testsystem.
§ 862.1635 - Total protein test system.
§ 862.1640 - Protein-bound iodine testsystem.
§ 862.1645 - Urinary protein or albumin(nonquantitative) test system.
§ 862.1650 - Pyruvate kinase testsystem.
§ 862.1655 - Pyruvic acid test system.
§ 862.1660 - Quality control material(assayed and unassayed).
§ 862.1665 - Sodium test system.
§ 862.1670 - Sorbitol dehydrogenase testsystem.
§ 862.1675 - Blood specimen collectiondevice.
§ 862.1678 - Tacrolimus test system.
§ 862.1680 - Testosterone test system.
§ 862.1685 - Thyroxine-binding globulin testsystem.
§ 862.1690 - Thyroid stimulating hormonetest system.
§ 862.1695 - Free thyroxine test system.
§ 862.1700 - Total thyroxine testsystem.
§ 862.1705 - Triglyceride test system.
§ 862.1710 - Total triiodothyronine testsystem.
§ 862.1715 - Triiodothyronine uptake testsystem.
§ 862.1720 - Triose phosphate isomerase testsystem.
§ 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) testsystem.
§ 862.1785 - Urinary urobilinogen(nonquantitative) test system.
§ 862.1790 - Uroporphyrin test system.
§ 862.1795 - Vanilmandelic acid testsystem.
§ 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 massspectrometry test system.
Subpart C - Clinical Laboratory Instruments
§ 862.2050 - General purpose laboratoryequipment labeled or promoted for a specific medical use.
§ 862.2100 - Calculator/data processingmodule for clinical use.
§ 862.2120 - Continuous glucose monitor datamanagement system.
§ 862.2140 - Centrifugal chemistry analyzerfor clinical use.
§ 862.2150 - Continuous flow sequentialmultiple chemistry analyzer for clinical use.
§ 862.2160 - Discrete photometric chemistryanalyzer for clinical use.
§ 862.2170 - Micro chemistry analyzer forclinical use.
§ 862.2230 - Chromatographic separationmaterial for clinical use.
§ 862.2250 - Gas liquid chromatographysystem for clinical use.
§ 862.2260 - High pressure liquidchromatography system for clinical use.
§ 862.2265 - High throughput genomicsequence analyzer for clinical use.
§ 862.2270 - Thin-layer chromatographysystem for clinical use.
§ 862.2300 - Colorimeter, photometer, orspectrophotometer for clinical use.
§ 862.2310 - Clinical sampleconcentrator.
§ 862.2320 - Beta or gamma counter forclinical use.
§ 862.2400 - Densitometer/scanner(integrating, reflectance, TLC, or radiochromatogram) for clinicaluse.
§ 862.2485 - Electrophoresis apparatus forclinical use.
§ 862.2500 - Enzyme analyzer for clinicaluse.
§ 862.2540 - Flame emission photometer forclinical use.
§ 862.2560 - Fluorometer for clinicaluse.
§ 862.2570 - Instrumentation for clinicalmultiplex test systems.
§ 862.2680 - Microtitrator for clinicaluse.
§ 862.2700 - Nephelometer for clinicaluse.
§ 862.2720 - Plasma oncometer for clinicaluse.
§ 862.2730 - Osmometer for clinical use.
§ 862.2750 - Pipetting and diluting systemfor clinical use.
§ 862.2800 - Refractometer for clinicaluse.
§ 862.2850 - Atomic absorptionspectrophotometer for clinical use.
§ 862.2860 - Mass spectrometer for clinicaluse.
§ 862.2900 - Automated urinalysissystem.
§ 862.2920 - Plasma viscometer for clinicaluse.
Subpart D - Clinical Toxicology TestSystems
§ 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 testsystem.
§ 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 toxicologycalibrator.
§ 862.3220 - Carbon monoxide testsystem.
§ 862.3240 - Cholinesterase test system.
§ 862.3250 - Cocaine and cocaine metabolitetest system.
§ 862.3270 - Codeine test system.
§ 862.3280 - Clinical toxicology controlmaterial.
§ 862.3300 - Digitoxin test system.
§ 862.3320 - Digoxin test system.
§ 862.3350 - Diphenylhydantoin testsystem.
§ 862.3360 - Drug metabolizing enzymegenotyping system.
§ 862.3380 - Ethosuximide test system.
§ 862.3450 - Gentamicin 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 testsystem.
§ 862.3620 - Methadone test system.
§ 862.3630 - Methaqualone test system.
§ 862.3640 - Morphine test system.
§ 862.3645 - Neuroleptic drugs radioreceptorassay test system.
§ 862.3650 - Opiate test system.
§ 862.3652 - Organophosphate testsystem.
§ 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 moleculardiagnostic 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 drugstest system.
§ 862.3950 - Vancomycin test system.
