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862.2250 Gas liquid chromatography system

for clinical use. 862.2260 High pressure liquid chroma

tography system for clinical use. 862.2270 Thin-layer chromatography system

for clinical use. 862.2300 Colorimeter, photometer, or spec

trophotometer 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 clin

ical use. 862.2500 Enzyme analyzer for clinical use. 862.2540 Flame emission photometer for

clinical use. 862.2560 Fluorometer for clinical use. 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 spectrophotom

eter for clinical use. 862.2860 Mass spectrometer for clinical use. 862.2900 Automated urinalysis system. 862.2920 Plasma viscometer for clinical use.

862.3630 Methaqualone test system. 862.3640 Morphine test system, 862.3645 Neuroleptic drugs radioreceptor

assay test system. 862.3650 Opiate 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. 862.3830 Salicylate 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.

AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

SOURCE: 52 FR 16122, May 1, 1987, unless otherwise noted.

Subpart A-General Provisions

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. 862.3100 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. 862.3250 Cocaine and cocaine metabolite test

system. 862.3270 Codeine test system. 862.3280 Clinical toxicology control mate

rial. 862.3300 Digitoxin test system. 862.3320 Digoxin test system. 862.3350 Diphenylhydantoin test 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. 862.3600 Mercury test system. 862.3610 Methamphetamine test system. 862.3620 Methadone test system.

$ 862.1 Scope.

(a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required in 8 807.87.

(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

$ 862.2 Regulation of calibrators.

Many devices classified in this part are intended to be used with a calibrator. A calibrator has a reference value assigned to it which serves as the basis by which test results of patients are derived or calculated. The calibrator for a device may be (a) manufactured and distributed separately from the device with which it is intended to be used, (b) manufactured and distributed as one of several device components, such as in a kit of reagents, or (c) built-in as an integral part of the device. Because of the central role that a calibrator plays in the measurement process and the critical effect calibrators have on accuracy of test results, elsewhere in this part, all three of these types of calibrators (88 862.1150 and 862.3200 of this part) are classified into class II, notwithstanding the classification of the device with which it is intended to be used. Thus, a device and its calibrator may have different classifications, even if the calibrator is built into the device. $ 862.3 Effective dates of requirement

for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's

issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new" device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

8862.9 Limitations of exemptions from

section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

Subpart B-Clinical Chemistry Test

Systems

$ 862.1020 Acid phosphatase (total or

prostatic) test system. (a) Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

(b) Classification. Class II.

$ 862.1025 Adrenocorticotropic hor

mone (ACTH) test system. (a) Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

(b) Classification. Class II.

eases

of

(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental Scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(C) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic dis

with the exception immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as quired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in $ 812.3(k) of this chapter; and

(9) For near patient testing (point of care).

as

ac

or

$ 862.1030 Alanine amino transferase

(ALT/SGPT) test system. (a) Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $ 862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000)

8 862.1035 Albumin test system.

(a) Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

(b) Classification. Class II.

[65 FR 2304, Jan. 14, 2000)

(diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds including delta-aminolevulinic acid).

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to $862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000)

$ 862.1040 Aldolase test system.

(a) Identification. An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchennetype muscular dystrophy.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $ 862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000) $862.1045 Aldosterone test system.

(a) Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism,

selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.

(b) Classification. Class II.

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8 862.1065 Ammonia test system.

(a) Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

(b) Classification. Class I. 8862.1070 Amylase test system.

(a) Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

(b) Classification. Class II. 8862.1075 Androstenedione test sys

tem. (a) Identification. An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $ 862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000) 8862.1080 Androsterone test system.

(a) Identification. An androsterone test system is a device intended to measure the hormone adrosterone in serum, plasma, and urine. Androsterone measurements are used in the

8 862.1060 Delta-aminolevulinic acid

test system. (a) Identification. A deltaaminolevulinic acid test system is a device intended to measure the level of delta-aminolevulinic acid (a precursor of porphyrin) in urine. Deltaaminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias

a

or

serum

diagnosis and treatment of gonadal and adrenal diseases.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000)

ity of the enzyme aspartate amino transferase (AST) (also known as serum glutamic oxaloacetic transferase SGOT) in

and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

(b) Classification. Class II.

of

$ 862.1110 Bilirubin (total or direct)

test system. (a) Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

(b) Classification. Class II.

un

$862.1085 Angiotensin I and renin test

system. (a) Identification. An angiotensin I and renin test system is a device intended to measure the level angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.

(b) Classification. Class II. 8862.1090 Angiotensin converting en

zyme (A.C.E.) test system. (a) Identification. An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.

(b) Classification. Class II. 8862.1095 Ascorbic acid test system.

(a) Identification. An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 8 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]

8 862.1113 Bilirubin (total and

bound) in the neonate test system. (a) Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

(b) Classification. Class I.

(54 FR 30206, July 19, 1989)

8 862.1115 Urinary bilirubin and its

conjugates (nonquantitative) test

system. (a) Identification. A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $ 862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000)

$862.1100 Aspartate amino transferase

(AST/SGOT) test system. (a) Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activ

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