used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome. (b) Classification. Class I.

§862.1070 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.

§862.1075 Androstenedione test system.

(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]

§ 862.1080 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 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]

§ 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 of 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.

§ 862.1090 Angiotensin converting enzyme (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.

§862.1095 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 § 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 activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum 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.

§ 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

$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]

$862.1118 Biotinidase test system.

(a) Identification. The biotinidase test system is an in vitro diagnostic device intended to measure the activity of the enzyme biotinidase in blood. Measurements of biotinidase are used in the treatment and diagnosis of biotinidase deficiency, an inborn error of metabolism in infants, characterized by the inability to utilize dietary protein bound vitamin or to recycle endogenous biotin. The deficiency may result in irreversible neurological impairment.

(b) Classification. Class II (special controls). The special control is sale,

distribution, and use in accordance with the prescription device requirements in § 801.109 of this chapter.

[65 FR 16521, Mar. 29, 2000]

EFFECTIVE DATE NOTE: At 65 FR 16521, Mar. 29, 2000, §862.1118 was added, effective Apr. 28, 2000.

§ 862.1120 Blood gases (Pco2, P。2) and blood pH test system.

(a) Identification. A blood gases (Pco2, Po2) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (Pco2, Po2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

(b) Classification. Class II.

§862.1130 Blood volume test system.

(a) Identification. A blood volume test system is a device intended to measure the circulating blood volume. Blood volume measurements are used in the diagnosis and treatment of shock, hemorrhage, and polycythemia vera (a disease characterized by an absolute increase in erythrocyte mass and total blood volume).

(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]

§862.1135 C-peptides of proinsulin test system.

(a) Identification. A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.

(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]

§862.1155 Human

chorionic gonadotropin (HCG) test system. (a) Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy—(1) Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.

(2) Classification. Class II.

(b) Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy— (1) Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

(2) Classification. Class III.

(3) Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.

§862.1160 Bicarbonate/carbon dioxide test system.

(a) Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base bal

ance.

(b) Classification. Class II.

§862.1165 Catecholamines (total) test system.

(a) Identification. A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, and ganglioneuroma, retinoblastoma).

(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]

§862.1170 Chloride test system.

(a) Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

(b) Classification. Class II.

$862.1175 Cholesterol (total) test system.

(a) Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

(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]

$862.1177 Cholylglycine test system.

(a) Identification. A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease. (b) Classification. Class II.

$862.1180 Chymotrypsin test system.

(a) Identification. A chymotrypsin test system is a device intended to measure the activity of the enzyme chymotrypsin in blood and other body fluids and in feces. Chymotrypsin measurements are used in the diagnosis and treatment of pancreatic exocrine insufficiency.

(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]

ical symptoms of masculinization and hypertension.

(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]

§862.1187 Conjugated sulfolithocholic acid (SLCG) test system.

(a) Identification. A conjugated sulfolithocholic acid (SLCG) test system is a device intended to measure the bile acid SLCG in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

(b) Classification. Class II.

§862.1190 Copper test system.

(a) Identification. A copper test system is a device intended to measure copper levels in plasma, serum, and urine. Measurements of copper are used in the diagnosis and treatment of anemia, infections, inflammations, and Wilson's disease (a hereditary disease primarily of the liver and nervous system). Test results are also used in monitoring patients with Hodgkin's disease (a disease primarily of the lymph system).

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]

8862.1195 Corticoids test system.

(a) Identification. A corticoids test system is a device intended to measure the levels of corticoids (hormones of the adrenal cortex) in serum and p lasma. Measurements of corticoids are used in the diagnosis and treatment of disorders of the cortex of the adrenal glands, especially those associated with hypertension and electrolyte disturbances.

(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]

§862.1200 Corticosterone test system. (a) Identification. A corticosterone test system is a device intended to measure corticosterone (a steroid secreted by the adrenal gland) levels in plasma. Measurements of corticosterone are used in the diagnosis and treatment of adrenal disorders such as adrenal cortex disorders and blocks in cortisol synthesis.

(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]

§ 862.1210 Creatine test system.

(a) Identification. A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]

isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchennetype muscular dystrophy.

(b) Classification. Class II. §862.1225 Creatinine test system.

(a) Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

(b) Classification. Class II. $862.1230 Cyclic AMP test system.

(a) Identification. A cyclic AMP test system is a device intended to measure the level of adenosine 3', 5'monophosphate (cyclic AMP) in plasma, urine, and other body fluids. Cyclic AMP measurements are used in the diagnosis and treatment of endocrine disorders, including hyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP measurements may also be used in the diagnosis and treatment of Graves' disease (a disorder of the thyroid) and in the differentiation of causes of hypercalcemia (elevated levels of serum calcium.)

(b) Classification. Class II.

§862.1240 Cystine test system.

(a) Identification. A cystine test system is a device intended to measure the amino acid cystine in urine. Cystine measurements are used in the diagnosis of cystinuria (occurrence of cystine in urine). Patients with cystinuria frequently develop kidney calculi (stones).

(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]