Title 21, Part 862 — Clinical Chemistry and Clinical Toxicology Devices

Scope.

Regulation of calibrators.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Acid phosphatase (total or prostatic) test system.

Adrenocorticotropic hormone (ACTH) test system.

Alanine amino transferase (ALT/SGPT) test system.

Albumin test system.

Aldolase test system.

Aldosterone test system.

Alkaline phosphatase or isoenzymes test system.

Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.

Delta-aminolevulinic acid test system.

Ammonia test system.

Amylase test system.

Androstenedione test system.

Androsterone test system.

Angiotensin I and renin test system.

Angiotensin converting enzyme (A.C.E.) test system.

Anti-mullerian hormone test system.

Menopause test system.

Ascorbic acid test system.

Aspartate amino transferase (AST/SGOT) test system.

Bilirubin (total or direct) test system.

Bilirubin (total and unbound) in the neonate test system.

Urinary bilirubin and its conjugates (nonquantitative) test system.

B-type natriuretic peptide test system.

Biotinidase test system.

Blood gases (P, P) and blood pH test system.

Blood volume test system.

C-peptides of proinsulin test system.

Calcitonin test system.

Calcium test system.

Calibrator.

Human chorionic gonadotropin (HCG) test system.

Bicarbonate/carbon dioxide test system.

Cardiac allograft gene expression profiling test system.

Catecholamines (total) test system.

Chloride test system.

Cholesterol (total) test system.

Cholylglycine test system.

Chymotrypsin test system.

Compound S (11-deoxycortisol) test system.

Conjugated sulfolithocholic acid (SLCG) test system.

Copper test system.

Corticoids test system.

Corticosterone test system.

Cortisol (hydrocortisone and hydroxycorticosterone) test system.

Creatine test system.

Creatine phosphokinase/creatine kinase or isoenzymes test system.

Acute kidney injury test system.

Creatinine test system.

Cyclic AMP test system.

Cyclosporine test system.

Cystine test system.

Dehydroepiandrosterone (free and sulfate) test system.

Desoxycorticosterone test system.

2,3-Diphosphoglyceric acid test system.

Estradiol test system.

Estriol test system.

Estrogens (total, in pregnancy) test system.

Estrogens (total, nonpregnancy) test system.

Estrone test system.

Etiocholanolone test system.

Fatty acids test system.

Folic acid test system.

Follicle-stimulating hormone test system.

Formiminoglutamic acid (FIGLU) test system.

Galactose test system.

Galactose-1-phosphate uridyl transferase test system.

Gastric acidity test system.

Gastrin test system.

Globulin test system.

Glucagon test system.

Urinary glucose (nonquantitative) test system.

Glucose test system.

Continuous glucose monitor secondary alarm system.

Integrated continuous glucose monitoring system.

Interoperable automated glycemic controller.

Insulin therapy adjustment device.

Gamma-glutamyl transpeptidase and isoenzymes test system.

Glutathione test system.

Human growth hormone test system.

Hemoglobin A1c test system.

Histidine test system.

Urinary homocystine (nonquantitative) test system.

Hydroxybutyric dehydrogenase test system.

17-Hydroxycorticosteroids (17-ketogenic steroids) test system.

5-Hydroxyindole acetic acid/serotonin test system.

17-Hydroxyprogesterone test system.

Hydroxyproline test system.

Immunoreactive insulin test system.

Iron (non-heme) test system.

Iron-binding capacity test system.

Isocitric dehydrogenase test system.

17-Ketosteroids test system.

Ketones (nonquantitative) test system.

Lactate dehydrogenase test system.

Lactate dehydrogenase isoenzymes test system.

Lactic acid test system.

Lecithin/sphingomyelin ratio in amniotic fluid test system.

Leucine aminopeptidase test system.

Lipase test system.

Lipid (total) test system.

Lipoprotein test system.

Luteinizing hormone test system.

Lysosomal storage disorder newborn screening test system.

Lysozyme (muramidase) test system.

Breast milk macronutrients test system.

Magnesium test system.

Malic dehydrogenase test system.

Mucopolysaccharides (nonquantitative) test system.

Muscular dystrophy newborn screening test.

Methylmalonic acid (nonquantitative) test system.

Nitrite (nonquantitative) test system.

Nitrogen (amino-nitrogen) test system.

5′-Nucleotidase test system.

Plasma oncometry test system.

Ornithine carbamyl transferase test system.

Osmolality test system.

Oxalate test system.

Parathyroid hormone test system.

Urinary pH (nonquantitative) test system.

Phenylalanine test system.

Urinary phenylketones (nonquantitative) test system.

6-Phosphogluconate dehydrogenase test system.

Phosphohexose isomerase test system.

Phospholipid test system.

Phosphorus (inorganic) test system.

Human placental lactogen test system.

Porphobilinogen test system.

Porphyrins test system.

Potassium test system.

Pregnanediol test system.

Pregnanetriol test system.

Pregnenolone test system.

Progesterone test system.

Prognostic test for assessment of liver related disease progression.

Prolactin (lactogen) test system.

Protein (fractionation) test system.

Total protein test system.

Protein-bound iodine test system.

Urinary protein or albumin (nonquantitative) test system.

Pyruvate kinase test system.

Pyruvic acid test system.

Quality control material (assayed and unassayed).

Sodium test system.

Sorbitol dehydrogenase test system.

Blood specimen collection device.

Blood collection device for cell-free nucleic acids.

Tacrolimus test system.

Testosterone test system.

Thyroxine-binding globulin test system.

Thyroid stimulating hormone test system.

Free thyroxine test system.

Total thyroxine test system.

Triglyceride test system.

Total triiodothyronine test system.

Triiodothyronine uptake test system.

Triose phosphate isomerase test system.

Trypsin test system.

Free tyrosine test system.

Urea nitrogen test system.

Uric acid test system.

Urinary calculi (stones) test system.

Urinary urobilinogen (nonquantitative) test system.

Uroporphyrin test system.

Vanilmandelic acid test system.

Vitamin A test system.

Vitamin B test system.

Vitamin E test system.

Xylose test system.

Vitamin D test system.

Total 25-hydroxyvitamin D mass spectrometry test system.

General purpose laboratory equipment labeled or promoted for a specific medical use.

Calculator/data processing module for clinical use.

Continuous glucose monitor data management system.

Centrifugal chemistry analyzer for clinical use.

Continuous flow sequential multiple chemistry analyzer for clinical use.

Discrete photometric chemistry analyzer for clinical use.

Micro chemistry analyzer for clinical use.

Chromatographic separation material for clinical use.

Gas liquid chromatography system for clinical use.

High pressure liquid chromatography system for clinical use.

High throughput genomic sequence analyzer for clinical use.

Thin-layer chromatography system for clinical use.

Colorimeter, photometer, or spectrophotometer for clinical use.

Clinical sample concentrator.

Beta or gamma counter for clinical use.

Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

Electrophoresis apparatus for clinical use.

Enzyme analyzer for clinical use.

Flame emission photometer for clinical use.

Fluorometer for clinical use.

Instrumentation for clinical multiplex test systems.

Microtitrator for clinical use.

Nephelometer for clinical use.

Plasma oncometer for clinical use.

Osmometer for clinical use.

Pipetting and diluting system for clinical use.

Refractometer for clinical use.

Atomic absorption spectrophotometer for clinical use.

Mass spectrometer for clinical use.

Automated urinalysis system.

Plasma viscometer for clinical use.

Acetaminophen test system.

Amikacin test system.

Alcohol test system.

Breath-alcohol test system.

Breath nitric oxide test system.

Amphetamine test system.

Antimony test system.

Arsenic test system.

Barbiturate test system.

Benzodiazepine test system.

Clinical toxicology calibrator.

Carbon monoxide test system.

Cholinesterase test system.

Clozapine test system.

Cocaine and cocaine metabolite test system.

Codeine test system.

Clinical toxicology control material.

Digitoxin test system.

Digoxin test system.

Diphenylhydantoin test system.

Drug metabolizing enzyme genotyping system.

Pharmacogenetic assessment system.

Ethosuximide test system.

Gentamicin test system.

Plazomicin test system.

Kanamycin test system.

Lead test system.

Lidocaine test system.

Lithium test system.

Lysergic acid diethylamide (LSD) test system.

Meprobamate test system.

Mercury test system.

Methamphetamine test system.

Methadone test system.

Methaqualone test system.

Morphine test system.

Neuroleptic drugs radioreceptor assay test system.

Opiate test system.

Organophosphate test system.

Phenobarbital test system.

Phenothiazine test system.

Primidone test system.

Propoxyphene test system.

Quinine test system.

Reagents for molecular diagnostic instrument test systems.

Salicylate test system.

Sirolimus test system.

Sulfonamide test system.

Cannabinoid test system.

Theophylline test system.

Tobramycin test system.

Tricyclic antidepressant drugs test system.

Vancomycin test system.

Voriconazole test system.