Food and Drug Administration, HHS § 862.1045

(2) For use in screening or diagnosis § 862.1030 Alanine amino transferase of familial or acquired genetic dis- (ALT/SGPT) test system. orders, including inborn errors of me- (a) Identification. An alanine amino tabolism; transferase (ALT/SGPT) test system is (3) For measuring an analyte that a device intended to measure the activ- serves as a surrogate marker for ity of the enzyme alanine amino trans- screening, diagnosis, or monitoring ferase (ALT) (also known as a serum life-threatening diseases such as ac- glutamic pyruvic transaminase or quired immune deficiency syndrome SGPT) in serum and plasma. Alanine (AIDS), chronic or active hepatitis, tu- amino transferase measurements are berculosis, or myocardial infarction or used in the diagnosis and treatment of to monitor therapy; certain diseases (e.g., viral hepa- (4) For assessing the risk of cardio- titis and cirrhosis) and diseases. vascular diseases; (b) Classification. Class I (general con- (5) For use in diabetes management; trols). The device is exempt from the (6) For identifying or inferring the premarket notification procedures in identity of a microorganism directly subpart E of part 807 of this chapter from clinical material; subject to § 862.9. (7) For detection of antibodies to [52 FR 16122, May 1, 1987, as amended at 65 microorganisms other than FR 2305, Jan. 14, 2000] immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or § 862.1035 Albumin test system. are used to determine immunity, or the (a) Identification. An albumin test assay is intended for use in matrices system is a device intended to measure other than serum or plasma; the albumin concentration in serum (8) For noninvasive testing as defined and plasma. Albumin measurements in § 812.3(k) of this chapter; and are used in the diagnosis and treat- (9) For near patient testing (point of ment of numerous diseases involving care). primarily the liver or kidneys. (b) Classification. Class II. [65 FR 2304, Jan. 14, 2000] § 862.1040 Aldolase test system. Subpart B—Clinical Chemistry Test (a) Identification. An aldolase test Systems system is a device intended to measure the activity of the enzyme aldolase in § 862.1020 Acid phosphatase (total or serum or plasma. Aldolase measure- prostatic) test system. ments are used in the diagnosis and (a) Identification. An acid phosphatase treatment of the early stages of acute (total or prostatic) test system is a de- hepatitis and for certain muscle dis- vice intended to measure the activity eases such as progressive Duchenne- of the acid phosphatase enzyme in plas- type muscular dystrophy. ma and serum. (b) Classification. Class I (general con- (b) Classification. Class II. trols). The device is exempt from the premarket notification procedures in § 862.1025 Adrenocorticotropic hor- subpart E of part 807 of this chapter mone (ACTH) test system. subject to § 862.9. (a) Identification. An adrenocortico- [52 FR 16122, May 1, 1987, as amended at 65 tropic (ACTH) test system is FR 2305, Jan. 14, 2000] a device intended to measure adreno- corticotropic hormone in plasma and § 862.1045 test system. serum. ACTH measurements are used (a) Identification. An aldosterone test in the differential diagnosis and treat- system is a device intended to measure ment of certain disorders of the adre- the hormone aldosterone in serum and nal glands such as Cushing’s syndrome, urine. Aldosterone measurements are adrenocortical insufficiency, and the used in the diagnosis and treatment of ectopic ACTH syndrome. primary aldosteronism (a disorder (b) Classification. Class II. caused by the excessive secretion of

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aldosterone by the ), hy- serum and urine. Amylase measure- pertension caused by primary ments are used primarily for the diag- aldosteronism, selective nosis and treatment of pancreatitis (in- hypoaldosteronism, edematous states, flammation of the ). and other conditions of electrolyte im- (b) Classification. Class II. balance. (b) Classification. Class II. § 862.1075 test sys- tem. § 862.1050 Alkaline phosphatase or (a) Identification. An androstenedione isoenzymes test system. test system is a device intended to (a) Identification. An alkaline phos- measure androstenedione (a substance phatase or isoenzymes test system is a secreted by the testes, , and adre- device intended to measure alkaline nal glands) in serum. Adrostenedione phosphatase or its isoenzymes (a group measurements are used in the diag- of enzymes with similar biological ac- nosis and treatment of females with ex- tivity) in serum or plasma. Measure- cessive levels of androgen (male sex ments of alkaline phosphatase or its hormone) production. isoenzymes are used in the diagnosis (b) Classification. Class I (general con- and treatment of liver, bone, parathy- trols). The device is exempt from the roid, and intestinal diseases. premarket notification procedures in (b) Classification. Class II. subpart E of part 807 of this chapter subject to § 862.9. § 862.1060 Delta-aminolevulinic acid test system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A delta- FR 2305, Jan. 14, 2000] aminolevulinic acid test system is a device intended to measure the level of § 862.1080 Androsterone test system. delta-aminolevulinic acid (a precursor (a) Identification. An androsterone of porphyrin) in urine. Delta- test system is a device intended to aminolevulinic acid measurements are measure the hormone adrosterone in used in the diagnosis and treatment of serum, plasma, and urine. Andros- lead poisoning and certain porphyrias terone measurements are used in the (diseases affecting the liver, gastro- diagnosis and treatment of gonadal and intestinal, and nervous systems that adrenal diseases. are accompanied by increased urinary (b) Classification. Class I (general con- excretion of various heme compounds trols). The device is exempt from the including delta-aminolevulinic acid). premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from pre- subject to § 862.9. market notification procedures in sub- [52 FR 16122, May 1, 1987, as amended at 65 part E of part 807 of this chapter sub- FR 2305, Jan. 14, 2000] ject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 § 862.1085 Angiotensin I and test FR 2305, Jan. 14, 2000] system. (a) Identification. An angiotensin I § 862.1065 Ammonia test system. and renin test system is a device in- (a) Identification. An ammonia test tended to measure the level of system is a device intended to measure angiotensin I generated by renin in ammonia levels in blood, serum, and plasma. Angiotensin I measurements plasma, Ammonia measurements are are used in the diagnosis and treat- used in the diagnosis and treatment of ment of certain types of hypertension. severe liver disorders, such as cir- (b) Classification. Class II. rhosis, hepatitis, and Reye’s syndrome. (b) Classification. Class I. § 862.1090 Angiotensin converting en- zyme (A.C.E.) test system. § 862.1070 Amylase test system. (a) Identification. An angiotensin con- (a) Identification. An amylase test verting enzyme (A.C.E.) test system is system is a device intended to measure a device intended to measure the activ- the activity of the enzyme amylase in ity of angiotensin converting enzyme

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in serum and plasma. Measurements § 862.1113 Bilirubin (total and un- obtained by this device are used in the bound) in the neonate test system. diagnosis and treatment of diseases (a) Identification. A bilirubin (total such as sarcoidosis, a disease charac- and unbound) in the neonate test sys- terized by the formation of nodules in tem is a device intended to measure the lungs, bones, and skin, and the levels of bilirubin (total and un- Gaucher’s disease, a hereditary dis- bound) in the blood (serum) of newborn order affecting the spleen. infants to aid in indicating the risk of (b) Classification. Class II. bilirubin encephalopathy (kernicterus). (b) Classification. Class I. § 862.1095 Ascorbic acid test system. [54 FR 30206, July 19, 1989] (a) Identification. An ascorbic acid test system is a device intended to § 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test measure the level of ascorbic acid (vi- system. tamin C) in plasma, serum, and urine. Ascorbic acid measurements are used (a) Identification. A urinary bilirubin and its conjugates (nonquantitative) in the diagnosis and treatment of test system is a device intended to ascorbic acid dietary deficiencies. measure the levels of bilirubin con- (b) Classification. Class I (general con- jugates in urine. Measurements of uri- trols). The device is exempt from the nary bilirubin and its conjugates (non- premarket notification procedures in quantitative) are used in the diagnosis subpart E of part 807 of this chapter and treatment of certain liver diseases. subject to § 862.9. (b) Classification. Class I (general con- trols). The device is exempt from the [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] premarket notification procedures in subpart E of part 807 of this chapter § 862.1100 Aspartate amino transferase subject to § 862.9. (AST/SGOT) test system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. An aspartate amino FR 2305, Jan. 14, 2000] transferase (AST/SGOT) test system is § 862.1117 B-type a device intended to measure the activ- test system. ity of the enzyme aspartate amino (a) Identification. The B-type transferase (AST) (also known as a natriuretic peptide (BNP) test system serum glutamic oxaloacetic transferase is an in vitro diagnostic device in- or SGOT) in serum and plasma. tended to measure BNP in whole blood Aspartate amino transferase measure- and plasma. Measurements of BNP are ments are used in the diagnosis and used as an aid in the diagnosis of pa- treatment of certain types of liver and tients with congestive heart failure. heart disease. (b) Classification. Class II (special (b) Classification. Class II. controls). The special control is ‘‘Class II Special Control Guidance Document § 862.1110 Bilirubin (total or direct) for B–Type Natriuretic Peptide Pre- test system. market Notifications; Final Guidance (a) Identification. A bilirubin (total or for Industry and FDA Reviewers.’’ direct) test system is a device intended [66 FR 12734, Feb. 28, 2001] to measure the levels of bilirubin (total or direct) in plasma or serum. Measure- § 862.1118 Biotinidase test system. ments of the levels of bilirubin, an or- (a) Identification. The biotinidase test ganic compound formed during the nor- system is an in vitro diagnostic device mal and abnormal distruction of red intended to measure the activity of the blood cells, if used in the diagnosis and enzyme biotinidase in blood. Measure- treatment of liver, hemolytic ments of biotinidase are used in the hematological, and metabolic dis- treatment and diagnosis of biotinidase orders, including hepatitis and gall deficiency, an inborn error of metabo- bladder block. lism in infants, characterized by the (b) Classification. Class II. inability to utilize dietary protein

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bound vitamin or to recycle endoge- subpart E of part 807 of this chapter nous biotin. The deficiency may result subject to § 862.9. in irreversible neurological impair- [52 FR 16122, May 1, 1987, as amended at 65 ment. FR 2305, Jan. 14, 2000] (b) Classification. Class II (special controls). The special control is sale, § 862.1140 test system. distribution, and use in accordance (a) Identification. A calcitonin test with the prescription device require- system is a device intended to measure ments in § 801.109 of this chapter. the hormone calcitonin (thyrocalcitonin) levels in plasma and [65 FR 16521, Mar. 29, 2000] serum. Calcitonin measurements are used in the diagnosis and treatment of § 862.1120 Blood gases (PCO2, PO2) and blood pH test system. diseases involving the thyroid and parathyroid glands, including car- (a) Identification. A blood gases (PCO2, cinoma and hyperparathyroidism (ex- PO2) and blood pH test system is a de- cessive activity of the parathyroid vice intended to measure certain gases gland). in blood, serum, plasma or pH of blood, (b) Classification. Class II. serum, and plasma. Measurements of § 862.1145 Calcium test system. blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treat- (a) Identification. A calcium test sys- ment of life-threatening acid-base dis- tem is a device intended to measure turbances. the total calcium level in serum. Cal- (b) Classification. Class II. cium measurements are used in the di- agnosis and treatment of parathyroid § 862.1130 Blood volume test system. disease, a variety of bone diseases, chronic renal disease and tetany (inter- (a) Identification. A blood volume test mittent muscular contractions or system is a device intended to measure spasms). the circulating blood volume. Blood (b) Classification. Class II. volume measurements are used in the diagnosis and treatment of shock, hem- § 862.1150 Calibrator. orrhage, and polycythemia vera (a dis- (a) Identification. A calibrator is a de- ease characterized by an absolute in- vice intended for medical purposes for crease in erythrocyte mass and total use in a test system to establish points blood volume). of reference that are used in the deter- (b) Classification. Class I (general con- mination of values in the measurement trols). The device is exempt from the of substances in human specimens. (See premarket notification procedures in also § 862.2 in this part.) subpart E of part 807 of this chapter (b) Classification. Class II. subject to § 862.9. § 862.1155 Human chorionic [52 FR 16122, May 1, 1987, as amended at 65 gonadotropin (HCG) test system. FR 2305, Jan. 14, 2000] (a) Human chorionic gonadotropin § 862.1135 C-peptides of proinsulin test (HCG) test system intended for the early system. detection of pregnancy—(1) Identification. A human chorionic gonadotropin (HCG) (a) Identification. A C-peptides of test system is a device intended for the proinsulin test system is a device in- early detection of pregnancy is in- tended to measure C-peptides of tended to measure HCG, a placental proinsulin levels in serum, plasma, and hormone, in plasma or urine. urine. Measurements of C-peptides of (2) Classification. Class II. proinsulin are used in the diagnosis (b) Human chorionic gonadotropin and treatment of patients with abnor- (HCG) test system intended for any uses mal secretion, including diabe- other than early detection of pregnancy— tes mellitus. (1) Identification. A human chorionic (b) Classification. Class I (general con- goadotropin (HCG) test system is a de- trols). The device is exempt from the vice intended for any uses other than premarket notification procedures in early detection of pregnancy (such as

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an aid in the diagnosis, prognosis, and disorders such as cystic fibrosis and di- management of treatment of persons abetic acidosis. with certain tumors or carcinomas) is (b) Classification. Class II. intended to measure HCG, a placental hormone, in plasma or urine. § 862.1175 Cholesterol (total) test sys- (2) Classification. Class III. tem. (3) Date PMA or notice of completion of (a) Identification. A cholesterol (total) a PDP is required. As of the enactment test system is a device intended to date of the amendments, May 28, 1976, measure cholesterol in plasma and an approval under section 515 of the act serum. Cholesterol measurements are is required before the device described used in the diagnosis and treatment of in paragraph (b)(1) may be commer- disorders involving excess cholesterol cially distributed. See § 862.3. in the blood and lipid and lipoprotein metabolism disorders. § 862.1160 Bicarbonate/carbon dioxide test system. (b) Classification. Class I (general con- trols). The device is exempt from the (a) Identification. A bicarbonate/car- premarket notification procedures in bon dioxide test system is a device in- subpart E of part 807 of this chapter tended to measure bicarbonate/carbon subject to § 862.9. dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide [52 FR 16122, May 1, 1987, as amended at 65 measurements are used in the diag- FR 2305, Jan. 14, 2000] nosis and treatment of numerous po- tentially serious disorders associated § 862.1177 Cholylglycine test system. with changes in body acid-base bal- (a) Identification. A cholylglycine test ance. system is a device intended to measure (b) Classification. Class II. the bile acid cholylglycine in serum. Measurements obtained by this device § 862.1165 Catecholamines (total) test are used in the diagnosis and treat- system. ment of liver disorders, such as cir- (a) Identification. A catecholamines rhosis or obstructive liver disease. (total) test system is a device intended (b) Classification. Class II. to determine whether a group of simi- lar compounds (epinephrine, § 862.1180 Chymotrypsin test system. , and ) are (a) A chymotrypsin present in urine and plasma. Identification. Catecholamine determinations are test system is a device intended to used in the diagnosis and treatment of measure the activity of the enzyme adrenal medulla and hypertensive dis- chymotrypsin in blood and other body orders, and for catecholamine-secret- fluids and in feces. Chymotrypsin ing tumors (pheochromo-cytoma, neu- measurements are used in the diag- roblastoma, ganglioneuroma, and nosis and treatment of pancreatic exo- retinoblastoma). crine insufficiency. (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 862.9. subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] FR 2305, Jan. 14, 2000]

§ 862.1170 Chloride test system. § 862.1185 Compound S (11- deoxycortisol) test system. (a) Identification. A chloride test sys- tem is a device intended to measure (a) Identification. A compound S (11- the level of chloride in plasma, serum, dioxycortisol) test system is a device sweat, and urine. Chloride measure- intended to measure the level of com- ments are used in the diagnosis and pound S (11-dioxycortisol) in plasma. treatment of electrolyte and metabolic Compound S is a steroid intermediate

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in the biosynthesis of the adrenal hor- with hypertension and electrolyte dis- mone . Measurements of com- turbances. pound S are used in the diagnosis and (b) Classification. Class I (general con- treatment of certain adrenal and pitui- trols). The device is exempt from the tary gland disorders resulting in clin- premarket notification procedures in ical symptoms of masculinization and subpart E of part 807 of this chapter hypertension. subject to § 862.9. (b) Classification. Class I (general con- trols). The device is exempt from the [52 FR 16122, May 1, 1987, as amended at 65 premarket notification procedures in FR 2305, Jan. 14, 2000] subpart E of part 807 of this chapter subject to § 862.9. § 862.1200 Corticosterone test system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A corticosterone FR 2305, Jan. 14, 2000] test system is a device intended to measure corticosterone (a steroid se- § 862.1187 Conjugated sulfolithocholic creted by the adrenal gland) levels in acid (SLCG) test system. plasma. Measurements of corticos- (a) Identification. A conjugated terone are used in the diagnosis and sulfolithocholic acid (SLCG) test sys- treatment of adrenal disorders such as tem is a device intended to measure disorders and blocks in the bile acid SLCG in serum. Measure- cortisol synthesis. ments obtained by this device are used (b) Classification. Class I (general con- in the diagnosis and treatment of liver trols). The device is exempt from the disorders, such as cirrhosis or obstruc- tive liver disease. premarket notification procedures in (b) Classification. Class II. subpart E of part 807 of this chapter subject to § 862.9. § 862.1190 Copper test system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A copper test sys- FR 2305, Jan. 14, 2000] tem is a device intended to measure copper levels in plasma, serum, and § 862.1205 Cortisol (hydrocortisone urine. Measurements of copper are used and hydroxycorticosterone) test in the diagnosis and treatment of ane- system. mia, infections, inflammations, and (a) Identification. A cortisol (hydro- Wilson’s disease (a hereditary disease and hydroxycorticosterone) primarily of the liver and nervous sys- test system is a device intended to tem). Test results are also used in mon- measure the cortisol se- itoring patients with Hodgkin’s disease creted by the adrenal gland in plasma (a disease primarily of the lymph sys- and urine. Measurements of cortisol tem). (b) Classification. Class I (general con- are used in the diagnosis and treat- trols). The device is exempt from the ment of disorders of the adrenal gland. premarket notification procedures in (b) Classification. Class II. subpart E of part 807 of this chapter subject to the limitations in § 862.9. § 862.1210 Creatine test system. (a) Identification. A creatine test sys- [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, tem is a device intended to measure 2001] creatine (a substance synthesized in the liver and pancreas and found in bio- § 862.1195 Corticoids test system. logical fluids) in plasma, serum, and (a) Identification. A corticoids test urine. Measurements of creatine are system is a device intended to measure used in the diagnosis and treatment of the levels of corticoids (hormones of muscle diseases and endocrine dis- the adrenal cortex) in serum and p orders including hyperthyroidism. lasma. Measurements of corticoids are (b) Classification. Class I (general con- used in the diagnosis and treatment of trols). The device is exempt from the disorders of the cortex of the adrenal premarket notification procedures in glands, especially those associated

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subpart E of part 807 of this chapter therapy with this drug. This generic subject to the limitations in § 862.9. type of device includes immunoassays and chromatographic assays for [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, cyclosporine. 2001] (b) Classification. Class II (special controls). The special control is ‘‘Class § 862.1215 Creatine phosphokinase/cre- II Special Controls Guidance Docu- atine kinase or isoenzymes test sys- ment: Cyclosporine and Tacrolimus As- tem. says; Guidance for Industry and FDA.’’ (a) Identification. A creatine See § 862.1(d) for the availability of this phosphokinase/creatine kinase or guidance document. isoenzymes test system is a device in- tended to measure the activity of the [67 FR 58329, Sept. 16, 2002] enzyme creatine phosphokinase or its § 862.1240 Cystine test system. isoenzymes (a group of enzymes with similar biological activity) in plasma (a) Identification. A cystine test sys- and serum. Measurements of creatine tem is a device intended to measure phosphokinase and its isoenzymes are the amino acid cystine in urine. Cys- used in the diagnosis and treatment of tine measurements are used in the di- myocardial infarction and muscle dis- agnosis of cystinuria (occurrence of eases such as progressive, Duchenne- cystine in urine). Patients with type muscular dystrophy. cystinuria frequently develop (b) Classification. Class II. calculi (stones). (b) Classification. Class I (general con- § 862.1225 Creatinine test system. trols). The device is exempt from the (a) Identification. A creatinine test premarket notification procedures in system is a device intended to measure subpart E of part 807 of this chapter creatinine levels in plasma and urine. subject to § 862.9. Creatinine measurements are used in [52 FR 16122, May 1, 1987, as amended at 65 the diagnosis and treatment of renal FR 2305, Jan. 14, 2000] diseases, in monitoring renal dialysis, and as a calculation basis for meas- § 862.1245 uring other urine analytes. (free and sulfate) test system. (b) Classification. Class II. (a) Identification. A § 862.1230 Cyclic AMP test system. dehydroepiandrosterone (free and sul- fate) test system is a device intended (a) Identification. A cyclic AMP test to measure dehydroepiandrosterone system is a device intended to measure (DHEA) and its sulfate in urine, serum, the level of adenosine 3′, 5′- plasma, and amniotic fluid. monophosphate (cyclic AMP) in plas- Dehydroepiandrosterone measurements ma, urine, and other body fluids. Cyclic are used in the diagnosis and treat- AMP measurements are used in the di- ment of DHEA-secreting adrenal car- agnosis and treatment of endocrine dis- cinomas. orders, including hyperparathyroidism (b) Classification. Class I (general con- (overactivity of the ). trols). The device is exempt from the Cyclic AMP measurements may also be premarket notification procedures in used in the diagnosis and treatment of subpart E of part 807 of this chapter Graves’ disease (a disorder of the thy- subject to § 862.9. roid) and in the differentiation of causes of hypercalcemia (elevated lev- [52 FR 16122, May 1, 1987, as amended at 65 els of serum calcium.) FR 2306, Jan. 14, 2000] (b) Classification. Class II. § 862.1250 Desoxycorticosterone test § 862.1235 Cyclosporine test system. system. (a) Identification. A cyclosporine test (a) Identification. A system is a device intended to quan- desoxycorticosterone test system is a titatively determine cyclosporine con- device intended to measure centrations as an aid in the manage- desoxycorticosterone (DOC) in plasma ment of transplant patients receiving and urine. DOC measurements are used

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in the diagnosis and treatment of pa- diagnosis and treatment of tients with hypermineralocorticoidism fetoplacental distress in certain cases (excess retention of sodium and loss of of high-risk pregnancy. potassium) and other disorders of the (b) Classification. Class I (general con- adrenal gland. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to § 862.9. subpart E of part 807 of this chapter subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1270 (total, in preg- nancy) test system. § 862.1255 2,3-Diphosphoglyceric acid test system. (a) Identification. As estrogens (total, (a) Identification. A 2,3- in pregnancy) test system is a device diphosphoglyceric acid test system is a intended to measure total estrogens in device intended to measure 2,3- plasma, serum, and urine during preg- diphosphoglyceric acid (2,3-DPG) in nancy. The device primarily measures erythrocytes (red blood cells). Meas- estrone plus . Measurements urements of 2,3-diphosphoglyceric acid of total estrogens are used to aid in the are used in the diagnosis and treat- diagnosis and treatment of ment of blood disorders that affect the fetoplacental distress in certain cases delivery of oxygen by erythrocytes to of high-risk pregnancy. tissues and in monitoring the quality (b) Classification. Class I (general con- of stored blood. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to § 862.9. subpart E of part 807 of this chapter subject to the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] § 862.1275 Estrogens (total, nonpreg- nancy) test system. § 862.1260 Estradiol test system. (a) Identification. As estrogens (total, (a) Identification. An estradiol test nonpregnancy) test system is a device system is a device intended to measure intended to measure the level of estro- estradiol, an estrogenic steroid, in gens (total estrone, estradiol, and es- plasma. Estradiol measurements are triol) in plasma, serum, and urine of used in the diagnosis and treatment of males and nonpregnant females. Meas- various hormonal sexual disorders and urement of estrogens (total, nonpreg- in assessing placental function in com- nancy) is used in the diagnosis and plicated pregnancy. treatment of numerous disorders, in- (b) Classification. Class I (general con- cluding infertility, amenorrhea (ab- trols). The device is exempt from the sence of menses) differentiation of pri- premarket notification procedures in mary and secondary ovarian malfunc- subpart E of part 807 of this chapter tion, secreting testicular and subject to § 862.9. ovarian tumors, and precocious pu- [52 FR 16122, May 1, 1987, as amended at 65 berty in females. FR 2306, Jan. 14, 2000] (b) Classification. Class I (general con- trols). The device is exempt from the § 862.1265 Estriol test system. premarket notification procedures in (a) Identification. An estriol test sys- subpart E of part 807 of this chapter tem is a device intended to measure es- subject to § 862.9. triol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. [52 FR 16122, May 1, 1987, as amended at 65 Estriol measurements are used in the FR 2306, Jan. 14, 2000]

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§ 862.1280 Estrone test system. serum. Folic acid measurements are (a) Identification. An estrone test sys- used in the diagnosis and treatment of tem is a device intended to measure megaloblastic anemia, which is charac- estrone, an estrogenic steroid, in plas- terized by the presence of megaloblasts ma. Estrone measurements are used in (an abnormal red blood cell series) in the diagnosis and treatment of numer- the bone marrow. ous disorders, including infertility, (b) Classification. Class II. amenorrhea, differentiation of primary [52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, and secondary ovarian malfunction, es- 1988] trogen secreting testicular and ovarian tumors, and precocious puberty in fe- § 862.1300 Follicle-stimulating hor- males. mone test system. (b) Classification. Class I (general con- trols). The device is exempt from the (a) Identification. A follicle-stimu- premarket notification procedures in lating hormone test system is a device subpart E of part 807 of this chapter intended to measure follicle-stimu- subject to § 862.9. lating hormone (FSH) in plasma, serum, and urine. FSH measurements [52 FR 16122, May 1, 1987, as amended at 65 are used in the diagnosis and treat- FR 2306, Jan. 14, 2000] ment of pituitary gland and gonadal § 862.1285 Etiocholanolone test system. disorders. (b) Classification. Class I (general con- (a) Identification. An etiocholanolone trols). The device is exempt from the test system is a device intended to premarket notification procedures in measure etiocholanolone in serum and urine. Etiocholanolone is a metabolic subpart E of part 807 of this chapter product of the hormone subject to § 862.9. and is excreted in the urine. [52 FR 16122, May 1, 1987, as amended at 65 Etiocholanolone measurements are FR 2306, Jan. 14, 2000] used in the diagnosis and treatment of disorders of the testes and . § 862.1305 Formiminoglutamic acid (b) Classification. Class I (general con- (FIGLU) test system. trols). The device is exempt from the (a) Identification. A premarket notification procedures in formiminoglutamic acid (FIGLU) test subpart E of part 807 of this chapter system is a device intended to measure subject to § 862.9. formiminolutamic acid in urine. [52 FR 16122, May 1, 1987, as amended at 65 FIGLU measurements obtained by this FR 2306, Jan. 14, 2000] device are used in the diagnosis of anemias, such as pernicious anemia § 862.1290 Fatty acids test system. and congenital hemolytic anemia. (a) Identification. A fatty acids test (b) Classification. Class I (general con- system is a device intended to measure trols). The device is exempt from the fatty acids in plasma and serum. Meas- premarket notification procedures in urements of fatty acids are used in the subpart E of part 807 of this chapter diagnosis and treatment of various dis- subject to the limitations in § 862.9. orders of lipid metabolism. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 53 trols). The device is exempt from the FR 21449, June 8, 1988; 66 FR 38787, July 25, premarket notification procedures in 2001] subpart E of part 807 of this chapter subject to the limitations in § 862.9. § 862.1310 Galactose test system. [52 FR 16122, May 1, 1987, as amended at 53 (a) Identification. A galactose test FR 21449, June 8, 1988; 66 FR 38787, July 25, system is a device intended to measure 2001] galactose in blood and urine. Galactose measurements are used in the diag- § 862.1295 Folic acid test system. nosis and treatment of the hereditary (a) Identification. A folic acid test sys- disease galactosemia (a disorder of ga- tem is a device intended to measure lactose metabolism) in infants. the vitamin folic acid in plasma and (b) Classification. Class I.

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§ 862.1315 Galactose-1-phosphate patients with numerous illnesses in- uridyl transferase test system. cluding severe liver and renal disease, (a) Identification. A galactose-1-phos- multiple myeloma, and other disorders phate uridyl transferase test system is of blood globulins. a device intended to measure the activ- (b) Classification. Class I (general con- ity of the enzyme galactose-1-phos- trols). The device is exempt from the phate uridyl transferase in premarket notification procedures in erythrocytes (red blood cells). Meas- subpart E of part 807 of this chapter urements of galactose-1-phosphate subject to § 862.9. uridyl transferase are used in the diag- nosis and treatment of the hereditary [52 FR 16122, May 1, 1987, as amended at 65 disease galactosemia (disorder of galac- FR 2306, Jan. 14, 2000] tose metabolism) in infants. § 862.1335 test system. (b) Classification. Class II. (a) Identification. A glucagon test sys- § 862.1320 Gastric acidity test system. tem is a device intended to measure (a) Identification. A gastric acidity the pancreatic hormone glucagon in test system is a device intended to plasma and serum. Glucagon measure- measure the acidity of gastric fluid. ments are used in the diagnosis and Measurements of gastric acidity are treatment of patients with various dis- used in the diagnosis and treatment of orders of carbohydrate metabolism, in- patients with peptic ulcer, Zollinger- cluding diabetes mellitus, hypo- Ellison syndrome (peptic ulcer due to glycemia, and hyperglycemia. -secreting tumor of the pan- (b) Classification. Class I (general con- creas), and related gastric disorders. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to § 862.9. subpart E of part 807 of this chapter subject to the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] § 862.1340 Urinary glucose (non- quantitative) test system. § 862.1325 Gastrin test system. (a) Identification. A urinary glucose (a) Identification. A gastrin test sys- (nonquantitative) test system is a de- tem is a device intended to measure vice intended to measure glucosuria the hormone gastrin in plasma and (glucose in urine). Urinary glucose serum. Measurements of gastrin are (nonquantitative) measurements are used in the diagnosis and treatment of used in the diagnosis and treatment of patients with ulcers, pernicious ane- carbohydrate metabolism disorders in- mia, and the Zollinger-Ellison syn- cluding diabetes mellitus, hypo- drome (peptic ulcer due to a gastrin-se- glycemia, and hyperglycemia. creting tumor of the pancreas). (b) Classification. Class II. (b) Classification. Class I (general con- trols). The device is exempt from the § 862.1345 Glucose test system. premarket notification procedures in subpart E of part 807 of this chapter (a) Identification. A glucose test sys- subject to § 862.9. tem is a device intended to measure glucose quantitatively in blood and [52 FR 16122, May 1, 1987, as amended at 65 other body fluids. Glucose measure- FR 2306, Jan. 14, 2000] ments are used in the diagnosis and § 862.1330 Globulin test system. treatment of carbohydrate metabolism disorders including diabetes mellitus, (a) Identification. A globulin test sys- neonatal hypoglycemia, and idiopathic tem is a device intended to measure hypoglycemia, and of pancreatic islet globulins (proteins) in plasma and serum. Measurements of globulin are cell carcinoma. used in the diagnosis and treatment of (b) Classification. Class II.

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§ 862.1360 Gamma-glutamyl subpart E of part 807 of this chapter transpeptidase and isoenzymes test subject to § 862.9. system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A gamma-glutamyl FR 2306, Jan. 14, 2000] transpeptidase and isoenzymes test system is a device intended to measure § 862.1375 Histidine test system. the activity of the enzyme gamma- (a) Identification. A histidine test sys- glutamyl transpeptidase (GGTP) in tem is a device intended to measure plasma and serum. Gamma-glutamyl free histidine (an amino acid) in plas- transpeptidase and isoenzymes meas- ma and urine. Histidine measurements urements are used in the diagnosis and are used in the diagnosis and treat- treatment of liver diseases such as al- ment of hereditary histidinemia char- coholic cirrhosis and primary and sec- acterized by excess histidine in the ondary liver tumors. blood and urine often resulting in men- (b) Classification. Class I (general con- tal retardation and disordered speech trols). The device is exempt from the development. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to § 862.9. premarket notification procedures in [52 FR 16122, May 1, 1987, as amended at 65 subpart E of part 807 of this chapter FR 2306, Jan. 14, 2000] subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 § 862.1365 Glutathione test system. FR 2306, Jan. 14, 2000] (a) Identification. A glutathione test system is a device intended to measure § 862.1377 Urinary homocystine (non- glutathione (the tripeptide of glycine, quantitative) test system. cysteine, and glutamic acid) in (a) Identification. A urinary erythrocytes (red blood cells). Gluta- homocystine (nonquantitative) test thione measurements are used in the system is a device intended to identify diagnosis and treatment of certain homocystine (an analogue of the amino drug-induced hemolytic (erythrocyte acid cystine) in urine. The identifica- destroying) anemias due to an inher- tion of urinary homocystine is used in ited enzyme deficiency. the diagnosis and treatment of (b) Classification. Class I (general con- homocystinuria (homosystine in trols). The device is exempt from the urine), a heritable metabolic disorder premarket notification procedures in which may cause mental retardation. subpart E of part 807 of this chapter (b) Classification. Class II. subject to the limitations in § 862.9 § 862.1380 Hydroxybutyric dehydro- [52 FR 16122, May 1, 1987, as amended at 53 genase test system. FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] (a) Identification. A hydroxybutyric dehydrogenase test system is a device § 862.1370 Human intended to measure the activity of the test system. enzyme alpha-hydroxybutric dehydro- (a) Identification. A human growth genase (HBD) in plasma or serum. HBD hormone test system is a device in- measurements are used in the diag- tended to measure the levels of human nosis and treatment of myocardial in- growth hormone in plasma. Human farction, renal damage (such as rejec- growth hormone measurements are tion of transplants), certain used in the diagnosis and treatment of hematological diseases (such as acute disorders involving the anterior lobe of leukemias and megaloblastic anemias) the pituitary gland. and, to a lesser degree, liver disease. (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in

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subpart E of part 807 of this chapter § 862.1395 17-Hydroxyprogesterone subject to the limitations in § 862.9. test system. [52 FR 16122, May 1, 1987, as amended at 53 (a) Identification. A 17- FR 21449, June 8, 1988; 66 FR 38787, July 25, hydroxyprogesterone test system is a 2001] device intended to measure 17- hydroxyprogesterone (a steroid) in § 862.1385 17-Hydroxycorticosteroids plasma and serum. Measurements of 17- (17-ketogenic steroids) test system. hydroxyprogesterone are used in the (a) Identification. A 17-hydroxy- diagnosis and treatment of various dis- corticosteroids (17-ketogenic steroids) orders of the adrenal glands or the ova- test system is a device intended to ries. measure corticosteroids that possess a (b) Classification. Class I (general con- dihydroxyacetone trols). 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 2306, Jan. 14, 2000] moiety on the steroid nucleus in urine. Corticosteroids with this chemical con- § 862.1400 Hydroxyproline test system. figuration include cortisol, cortisone (a) Identification. A hydroxyproline 11-desoxycortisol, test system is a device intended to desoxycorticosterone, and their measure the amino acid tetrahydroderivatives. This group of hydroxyproline in urine. hormones is synthesized by the adrenal Hydroxyproline measurements are used gland. Measurements of 17-hydroxy- in the diagnosis and treatment of var- corticosteroids (17-ketogenic steroids) ious (connective tissue) dis- are used in the diagnosis and treat- eases, bone disease such as Paget’s dis- ment of various diseases of the adrenal ease, and endocrine disorders such as or pituitary glands and gonadal dis- hyperparathyroidism and hyper- orders. thyroidism. (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 862.9. subject to § 862.9. [52 FR 16122, May. 1, 1987; 52 FR 29468, Aug. 7, [52 FR 16122, May 1, 1987, as amended at 65 1987, as amended at 65 FR 2306, Jan. 14, 2000] FR 2306, Jan. 14, 2000]

§ 862.1390 5-Hydroxyindole acetic acid/ § 862.1405 Immunoreactive insulin test system. serotonin test system. (a) Identification. An immunoreactive (a) Identification. A 5-hydroxyindole insulin test system is a device intended acetic acid/serotonin test system is a to measure immunoreactive insulin in device intended to measure 5- serum and plasma. Immunoreactive in- hydroxyindole acetic acid/serotonin in sulin measurements are used in the di- urine. Measurements of 5- agnosis and treatment of various car- hydroxyindole acetic acid/serotonin are bohydrate metabolism disorders, in- used in the diagnosis and treatment of cluding diabetes mellitus, and hypo- carcinoid tumors of endocrine tissue. glycemia. (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 862.9. subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] FR 2306, Jan. 14, 2000]

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§ 862.1410 Iron (non-heme) test system. and of other endocrine disorders, in- (a) Identification. An iron (non-heme) cluding hypertension, diabetes, and test system is a device intended to hypothyroidism. measure iron (non-heme) in serum and (b) Classification. Class I (general con- plasma. Iron (non-heme) measurements trols). The device is exempt from the are used in the diagnosis and treat- premarket notification procedures in ment of diseases such as iron defi- subpart E of part 807 of this chapter ciency anemia, hemochromatosis (a subject to § 862.9. disease associated with widespread de- posit in the tissues of two iron-con- [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] taining pigments, hemosiderin and hemofuscin, and characterized by pig- § 862.1435 Ketones (nonquantitative) mentation of the skin), and chronic test system. renal disease. (b) Classification. Class I. (a) Identification. A ketones (non- quantitative) test system is a device § 862.1415 Iron-binding capacity test intended to identify ketones in urine system. and other body fluids. Identification of (a) Identification. An iron-binding ca- ketones is used in the diagnosis and pacity test system is a device intended treatment of acidosis (a condition to measure iron-binding capacity in characterized by abnormally high acid- serum. Iron-binding capacity measure- ity of body fluids) or ketosis (a condi- ments are used in the diagnosis and tion characterized by increased produc- treatment of anemia. tion of ketone bodies such as acetone) (b) Classification. Class I. and for monitoring patients on § 862.1420 Isocitric dehydrogenase test ketogenic diets and patients with dia- system. betes. (a) Identification. An isocitric dehy- (b) Classification. Class I (general con- drogenase test system is a device in- trols). The device is exempt from the tended to measure the activity of the premarket notification procedures in enzyme isocitric dehydrogenase in subpart E of part 807 of this chapter serum and plasma. Isocitric dehydro- subject to § 862.9. genase measurements are used in the [52 FR 16122, May 1, 1987, as amended at 65 diagnosis and treatment of liver dis- FR 2307, Jan. 14, 2000] ease such as viral hepatitis, cirrhosis, or acute inflammation of the biliary § 862.1440 Lactate dehydrogenase test tract; pulmonary disease such as pul- system. monary infarction (local arrest or sud- (a) Identification. A lactate dehydro- den insufficiency of the blood supply to genase test system is a device intended the lungs), and diseases associated with to measure the activity of the enzyme pregnancy. (b) Classification. Class I (general con- lactate dehydrogenase in serum. Lac- trols). The device is exempt from the tate dehydrogenase measurements are premarket notification procedures in used in the diagnosis and treatment of subpart E of part 807 of this chapter liver diseases such as acute viral hepa- subject to the limitations in § 862.9. titis, cirrhosis, and metastatic car- cinoma of the liver, cardiac diseases [52 FR 16122, May 1, 1987, as amended at 53 such as myocardial infarction, and tu- FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] mors of the lung or kidneys. (b) Classification. Class II (special § 862.1430 17-Ketosteroids test system. controls). The device is exempt from (a) Identification. A 17-ketosteroids the premarket notification procedures test system is a device intended to in subpart E of part 807 of this chapter measure 17-ketosteroids in urine. Meas- subject to § 862.9. urements of 17-ketosteroids are used in [52 FR 16122, May 1, 1987, as amended at 63 the diagnosis and treatment of dis- FR 59225, Nov. 3, 1998] orders of the adrenal cortex and

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§ 862.1445 Lactate dehydrogenase the premarket notification procedures isoenzymes test system. in subpart E of part 807 of this chapter (a) Identification. A lactate dehydro- subject to § 862.9. genase isoenzymes test system is a de- [52 FR 16122, May 1, 1987, as amended at 65 vice intended to measure the activity FR 2307, Jan. 14, 2000] of lactate dehydrogenase isoenzymes (a group of enzymes with similar biologi- § 862.1465 Lipase test system. cal activity) in serum. Measurements (a) Identification. A lipase test system of lactate dehydrogenase isoenzymes is a device intended to measure the ac- are used in the diagnosis and treat- tivity of the enzymes lipase in serum. ment of liver diseases, such as viral Lipase measurements are used in diag- hepatitis, and myocardial infarction. nosis and treatment of diseases of the (b) Classification. Class II. pancreas such as acute pancreatitis § 862.1450 Lactic acid test system. and obstruction of the pancreatic duct. (b) Classification. Class I (general con- (a) Identification. A lactic acid test trols). The device is exempt from the system is a device intended to measure premarket notification procedures in lactic acid in whole blood and plasma. subpart E of part 807 of this chapter Lactic acid measurements that evalu- subject to § 862.9. ate the acid-base status are used in the diagnosis and treatment of lactic aci- [52 FR 16122, May 1, 1987, as amended at 65 dosis (abnormally high acidity of the FR 2307, Jan. 14, 2000] blood). (b) Classification. Class I (general con- § 862.1470 Lipid (total) test system. trols). The device is exempt from the (a) Identification. A lipid (total) test premarket notification procedures in system is a device intended to measure subpart E of part 807 of this chapter total lipids (fats or fat-like substances) subject to § 862.9. in serum and plasma. Lipid (total) [52 FR 16122, May 1, 1987, as amended at 65 measurements are used in the diag- FR 2307, Jan. 14, 2000] nosis and treatment of various diseases involving lipid metabolism and athero- § 862.1455 Lecithin/sphingomyelin sclerosis. ratio in amniotic fluid test system. (b) Classification. Class I (general con- (a) Identification. A lecithin/ trols). The device is exempt from the sphingomyelin ratio in amniotic fluid premarket notification procedures in test system is a device intended to subpart E of part 807 of this chapter measure the lecithin/sphingomyelin subject to the limitations in § 862.9. ratio in amniotic fluid. Lecithin and [52 FR 16122, May 1, 1987, as amended at 53 sphingomyelin are phospholipids (fats FR 21449, June 8, 1988; 66 FR 38788, July 25, or fat-like substances containing phos- 2001] phorus). Measurements of the lecithin/ sphingomyelin ratio in amniotic fluid § 862.1475 Lipoprotein test system. are used in evaluating fetal maturity. (a) Identification. A lipoprotein test (b) Classification. Class II. system is a device intended to measure § 862.1460 aminopeptidase lipoprotein in serum and plasma. test system. Lipoprotein measurements are used in the diagnosis and treatment of lipid (a) Identification. A leucine disorders (such as diabetes mellitus), aminopeptidase test system is a device atherosclerosis, and various liver and intended to measure the activity of the renal diseases. enzyme leucine amino-peptidase in serum, plasma, and urine. Leucine (b) Classification. Class I (general con- aminopeptidase measurements are used trols). The device is exempt from the in the diagnosis and treatment of liver premarket notification procedures in diseases such as viral hepatitis and ob- subpart E of part 807 of this chapter structive jaundice. subject to § 862.9. (b) Classification. Class I (general [52 FR 16122, May 1, 1987, as amended at 65 controls). The device is exempt from FR 2307, Jan. 14, 2000]

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§ 862.1485 test liver diseases, myocardial infarctions, system. cancer, and blood disorders such as (a) Identification. A luteinizing hor- myelogenous (produced in the bone mone test system is a device intended marrow) leukemia. to measure luteinizing hormone in (b) Classification. Class I (general serum and urine. Luteinizing hormone controls). The device is exempt from measurements are used in the diag- the premarket notification procedures nosis and treatment of gonadal dys- in subpart E of part 807 of this chapter function. subject to § 862.9. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 65 trols). The device is exempt from the FR 2307, Jan. 14, 2000] premarket notification procedures in subpart E of part 807 of this chapter § 862.1505 Mucopolysaccharides (non- quantitative) test system. subject to § 862.9. (a) Identification. A [52 FR 16122, May 1, 1987, as amended at 65 mucopolysaccharides (nonquantitative) FR 2307, Jan. 14, 2000] test system is a device intended to § 862.1490 Lysozyme (muramidase) test measure the levels of system. mucopolysaccharides in urine. Mucopolysaccharide measurements in (a) Identification. A lysozyme urine are used in the diagnosis and (muramidase) test system is a device treatment of various inheritable dis- intended to measure the activity of the orders that affect bone and connective bacteriolytic enzyme lysozyme tissues, such as Hurler’s, Hunter’s, (muramidase) in serum, plasma, leu- Sanfilippo’s, Scheie’s Morquio’s and kocytes, and urine. Lysozyme measure- Maroteaux-Lamy syndromes. ments are used in the diagnosis and (b) Classification. Class I (general con- treatment of monocytic leukemia and trols). The device is exempt from the kidney disease. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to § 862.9. premarket notification procedures in subpart E of part 807 of this chapter [52 FR 16122, May 1, 1987, as amended at 65 subject to the limitations in § 862.9. FR 2307, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 53 § 862.1509 Methylmalonic acid (non- FR 21449, June 8, 1988; 66 FR 38788, July 25, quantitative) test system. 2001] (a) Identification. A methylmalonic acid (nonquantitative) test system is a § 862.1495 Magnesium test system. device intended to identify (a) Identification. A magnesium test methylmalonic acid in urine. The iden- system is a device intended to measure tification of methylmalonic acid in magnesium levels in serum and plas- urine is used in the diagnosis and ma. Magnesium measurements are used treatment of methylmalonic aciduria, in the diagnosis and treatment of a heritable metabolic disorder which, if hypomagnesemia (abnormally low plas- untreated, may cause mental retarda- ma levels of magnesium) and tion. hypermagnesemia (abnormally high (b) Classification. Class II. plasma levels of magnesium). (b) Classification. Class I. § 862.1510 Nitrite (nonquantitative) test system. § 862.1500 Malic dehydrogenase test (a) Identification. A nitrite (non- system. quantitative) test system is a device (a) Identification. A malic dehydro- intended to identify nitrite in urine. genase test system is a device that is Nitrite identification is used in the di- intended to measure the activity of the agnosis and treatment of uninary tract enzyme malic dehydrogenase in serum infection of bacterial origin. and plasma. Malic dehydrogenase (b) Classification. Class I (general con- measurements are used in the diag- trols). The device is exempt from the nosis and treatment of muscle and premarket notification procedures in

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subpart E of part 807 of this chapter capillary permeability, such as edema subject to § 862.9. and shock. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] trols). The device is exempt from the premarket notification procedures in § 862.1515 Nitrogen (amino-nitrogen) subpart E of part 807 of this chapter test system. subject to § 862.9. (a) Identification. A nitrogen (amino- [52 FR 16122, May 1, 1987, as amended at 65 nitrogen) test system is a device in- FR 2307, Jan. 14, 2000] tended to measure amino acid nitrogen levels in serum, plasma, and urine. Ni- § 862.1535 Ornithine carbamyl trans- trogen (amino-nitrogen) measurements ferase test system. are used in the diagnosis and treat- (a) Identification. An ornithine ment of certain forms of severe liver carbamyl transferase test system is a disease and renal disorders. device intended to measure the activ- (b) Classification. Class I (general con- ity of the enzyme ornithine carbamyl trols). The device is exempt from the transferase (OCT) in serum. Ornithine premarket notification procedures in carbamyl transferase measurements subpart E of part 807 of this chapter are used in the diagnosis and treat- subject to the limitations in § 862.9. ment of liver diseases, such as infec- tious hepatitis, acute cholecystitis (in- [52 FR 16122, May 1, 1987, as amended at 53 flammation of the gall bladder), cir- FR 21449, June 8, 1988; 66 FR 38788, July 25, rhosis, and liver metastases. 2001] (b) Classification. Class I (general con- § 862.1520 5′-Nucleotidase test system. trols). The device is exempt from the premarket notification procedures in ′ (a) Identification. A 5 -nucleotidase subpart E of part 807 of this chapter test system is a device intended to subject to § 862.9. measure the activity of the enzyme 5′- nucleotidase in serum and plasma. [52 FR 16122, May 1, 1987, as amended at 65 Measurements of 5′-nucleotidase are FR 2307, Jan. 14, 2000] used in the diagnosis and treatment of liver diseases and in the differentia- § 862.1540 Osmolality test system. tions between liver and bone diseases (a) Identification. An osmolality test in the presence of elevated serum alka- system is a device intended to measure line phosphatase activity. ionic and nonionic solute concentra- (b) Classification. Class I (general con- tion in body fluids, such as serum and trols). The device is exempt from the urine. Osmolality measurement is used premarket notification procedures in as an adjunct to other tests in the eval- subpart E of part 807 of this chapter uation of a variety of diseases, includ- subject to § 862.9. ing kidney diseases (e.g., chronic pro- gressive renal failure), diabetes [52 FR 16122, May 1, 1987, as amended at 65 insipidus, other endocrine and meta- FR 2307, Jan. 14, 2000] bolic disorders, and fluid imbalances. § 862.1530 Plasma oncometry test sys- (b) Classification. Class I (general con- tem. trols). The device is exempt from the premarket notification procedures in (a) Identification. A plasma subpart E of part 807 of this chapter oncometry test system is a device in- subject to § 862.9. tended to measure plasma oncotic pres- sure. Plasma oncotic pressure is that [52 FR 16122, May 1, 1987, as amended at 65 portion of the total fluid pressure con- FR 2307, Jan. 14, 2000] tributed by proteins and other mol- ecules too large to pass through a spec- § 862.1542 Oxalate test system. ified membrane. Measurements of plas- (a) Identification. An oxalate test sys- ma oncotic pressure are used in the di- tem is a device intended to measure agnosis and treatment of dehydration the concentration of oxalate in urine. and circulatory disorders related to Measurements of oxalate are used to low serum protein levels and increased aid in the diagnosis or treatment of

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urinary stones or certain other meta- § 862.1560 Urinary phenylketones bolic disorders. (nonquantitative) test system. (b) Classification. Class I (general con- (a) Identification. A urinary trols). The device is exempt from the phenylketones (nonquantitative) test premarket notification procedures in system is a device intended to identify subpart E of part 807 of this chapter phenylketones (such as phenylpyruvic subject to § 862.9. acid) in urine. The identification of [52 FR 16122, May 1, 1987, as amended at 65 urinary phenylketones is used in the FR 2307, Jan. 14, 2000] diagnosis and treatment of congenital phenylketonuria which, if untreated, § 862.1545 test may cause mental retardation. system. (b) Classification. Class I (general con- (a) Identification. A parathyroid hor- trols). The device is exempt from the mone test system is a device intended premarket notification procedures in to measure the levels of parathyroid subpart E of part 807 of this chapter hormone in serum and plasma. Meas- subject to § 862.9. urements of parathyroid hormone lev- [52 FR 16122, May 1, 1987, as amended at 65 els are used in the differential diag- FR 2307, Jan. 14, 2000] nosis of hypercalcemia (abnormally high levels of calcium in the blood) and § 862.1565 6-Phosphogluconate dehy- hypocalcemia (abnormally low levels of drogenase test system. calcium in the blood) resulting from (a) Identification. A 6- disorders of calcium metabolism. phosphogluconate dehydrogenase test (b) Classification. Class II. system is a device intended to measure the activity of the enzyme 6- § 862.1550 Urinary pH (nonquantita- phosphogluconate dehydrogenase (6 tive) test system. PGD) in serum and erythrocytes. Meas- (a) Identification. A urinary pH (non- urements of 6-phosphogluconate dehy- quantitative) test system is a device drogenase are used in the diagnosis and intended to estimate the pH of urine. treatment of certain liver diseases Estimations of pH are used to evaluate (such as hepatitis) and anemias. the acidity or alkalinity of urine as it (b) Classification. Class I (general con- relates to numerous renal and meta- trols). The device is exempt from the bolic disorders and in the monitoring premarket notification procedures in of patients with certain diets. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to the limitations in § 862.9. trols). The device is exempt from the [52 FR 16122, May 1, 1987, as amended at 53 premarket notification procedures in FR 21449, June 8, 1988; 66 FR 38788, July 25, subpart E of part 807 of this chapter 2001] subject to § 862.9. § 862.1570 Phosphohexose isomerase [52 FR 16122, May 1, 1987, as amended at 65 test system. FR 2307, Jan. 14, 2000] (a) Identification. A phosphohexose § 862.1555 Phenylalanine test system. isomerase test system is a device in- tended to measure the activity of the (a) Identification. A phenylalanine enzyme phosphohexose isomerase in test system is a device intended to serum. Measurements of measure free phenylalanine (an amino phosphohexose isomerase are used in acid) in serum, plasma, and urine. the diagnosis and treatment of muscle Measurements of phenylalanine are diseases such as muscular dystrophy, used in the diagnosis and treatment of liver diseases such as hepatitis or cir- congenital phenylketonuria which, if rhosis, and metastatic carcinoma. untreated, may cause mental retarda- (b) Classification. Class I (general con- tion. trols). The device is exempt from the (b) Classification. Class II. premarket notification procedures in

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subpart E of part 807 of this chapter § 862.1590 Porphobilinogen test sys- subject to § 862.9. tem. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A porphobilinogen FR 2307, Jan. 14, 2000] test system is a device intended to measure porphobilinogen (one of the § 862.1575 Phospholipid test system. derivatives of hemoglobin which can (a) Identification. A phospholipid test make the urine a red color) in urine. system is a device intended to measure Measurements obtained by this device phospholipids in serum and plasma. are used in the diagnosis and treat- Measurements of phospholipids are ment of porphyrias (primarily inher- used in the diagnosis and treatment of ited diseases associated with disturbed disorders involving lipid (fat) metabo- porphyrine metabolism), lead poi- lism. soning, and other diseases character- (b) Classification. Class I (general con- ized by alterations in the heme path- trols). The device is exempt from the way. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to the limitations in § 862.9. premarket notification procedures in subpart E of part 807 of this chapter [52 FR 16122, May 1, 1987, as amended at 53 subject to § 862.9. FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1580 Phosphorus (inorganic) test system. § 862.1595 Porphyrins test system. (a) Identification. A phosphorus (inor- (a) Identification. A porphyrins test ganic) test system is a device intended system is a device intended to measure to measure inorganic phosphorus in porphyrins (compounds formed during serum, plasma, and urine. Measure- the biosynthesis of heme, a constituent ments of phosphorus (inorganic) are of hemoglobin, and related compounds) used in the diagnosis and treatment of in urine and feces. Measurements ob- various disorders, including parathy- tained by this device are used in the di- roid gland and kidney diseases, and vi- agnosis and treatment of lead poi- tamin D imbalance. soning, porphyrias (primarily inherited (b) Classification. Class I. diseases associated with disturbed por- phyrin metabolism), and other diseases § 862.1585 characterized by alterations in the test system. heme pathway. (a) Identification. A human placental (b) Classification. Class I (general con- lactogen test system is a device in- trols). The device is exempt from the tended to measure the hormone human premarket notification procedures in placental lactogen (HPL), (also known subpart E of part 807 of this chapter as human chorionic subject to § 862.9. somatomammotrophin (HCS)), in ma- [52 FR 16122, May 1, 1987, as amended at 65 ternal serum and maternal plasma. FR 2308, Jan. 14, 2000] Measurements of human placental lactogen are used in the diagnosis and § 862.1600 Potassium test system. clinical management of high-risk preg- (a) Identification. A potassium test nancies involving fetal distress associ- system is a device intended to measure ated with placental insufficiency. potassium in serum, plasma, and urine. Measurements of HPL are also used in Measurements obtained by this device pregnancies complicated by hyper- are used to monitor electrolyte balance tension, proteinuria, edema, post-ma- in the diagnosis and treatment of dis- turity, placental insufficiency, or pos- eases conditions characterized by low sible miscarriage. or high blood potassium levels. (b) Classification. Class II. (b) Classification. Class II.

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§ 862.1605 Pregnanediol test system. serum and plasma. Measurements ob- tained by this device are used in the di- (a) Identification. A pregnanediol test agnosis and treatment of disorders of system is a device intended to measure the ovaries or . pregnanediol (a major urinary meta- (b) Classification. Class I (general con- bolic product of ) in urine. trols). The device is exempt from the Measurements obtained by this device premarket notification procedures in are used in the diagnosis and treat- subpart E of part 807 of this chapter ment of disorders of the ovaries or pla- subject to § 862.9. centa. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 65 trols). The device is exempt from the FR 2308, Jan. 14, 2000] premarket notification procedures in subpart E of part 807 of this chapter § 862.1625 (lactogen) test sys- tem. subject to § 862.9. (a) Identification. A prolactin [52 FR 16122, May 1, 1987, as amended at 65 (lactogen) test system is a device in- FR 2308, Jan. 14, 2000] tended to measure the anterior pitui- § 862.1610 Pregnanetriol test system. tary polypeptide hormone prolactin in serum and plasma. Measurements ob- (a) Identification. A pregnanetriol test tained by this device are used in the di- system is a device intended to measure agnosis and treatment of disorders of pregnanetriol (a precursor in the bio- the gland or of the synthesis of the adrenal hormone portion of the brain. cortisol) in urine. Measurements ob- (b) Classification. Class I (general con- tained by this device are used in the di- trols). The device is exempt from the agnosis and treatment of congenital premarket notification procedures in adrenal hyperplasia (congenital en- subpart E of part 807 of this chapter largement of the adrenal gland). subject to § 862.9. (b) Classification. Class I (general con- trols). The device is exempt from the [52 FR 16122, May 1, 1987, as amended at 65 premarket notification procedures in FR 2308, Jan. 14, 2000] subpart E of part 807 of this chapter § 862.1630 Protein (fractionation) test subject to § 862.9. system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A protein (fraction- FR 2308, Jan. 14, 2000] ation) test system is a device intended to measure protein fractions in blood, § 862.1615 Pregnenolone test system. urine, cerebrospinal fluid, and other (a) Identification. A pregnenolone test body fluids. Protein fractionations are system is a device intended to measure used as a aid in recognizing abnormal pregnenolone (a precursor in the bio- proteins in body fluids and genetic synthesis of the adrenal hormone variants of proteins produced in dis- cortisol and adrenal androgen) in eases with tissue destruction. serum and plasma. Measurements ob- (b) Classification. Class I (general con- tained by this device are used in the di- trols). The device is exempt from the agnosis and treatment of diseases of premarket notification procedures in the adrenal cortex or the gonads. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to § 862.9. trols). The device is exempt from the [52 FR 16122, May 1, 1987, as amended at 65 premarket notification procedures in FR 2308, Jan. 14, 2000] subpart E of part 807 of this chapter subject to § 862.9. § 862.1635 Total protein test system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A total protein test FR 2308, Jan. 14, 2000] system is a device intended to measure total protein(s) in serum or plasma. § 862.1620 Progesterone test system. Measurements obtained by this device (a) Identification. A progesterone test are used in the diagnosis and treat- system is a device intended to measure ment of a variety of diseases involving progesterone (a female hormone) in the liver, kidney, or bone marrow as

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well as other metabolic or nutritional (b) Classification. Class I (general con- disorders. trols). The device is exempt from the (b) Classification. Class II (special premarket notification procedures in controls). The device is exempt from subpart E of part 807 of this chapter the premarket notification procedures subject to § 862.9. in subpart E of part 807 of this chapter subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 63 FR 59225, Nov. 3, 1998] § 862.1655 Pyruvic acid test system. § 862.1640 Protein-bound iodine test (a) Identification. A pyruvic acid test system. system is a device intended to measure (a) Identification. A protein-bound io- pyruvic acid (an intermediate com- dine test system is a device intended to pound in the metabolism of carbo- measure protein-bound iodine in hydrate) in plasma. Measurements ob- serum. Measurements of protein-bound tained by this device are used in the iodine obtained by this device are used evaluation of electrolyte metabolism in the diagnosis and treatment of thy- and in the diagnosis and treatment of roid disorders. acid-base and electrolyte disturbances (b) Classification. Class I (general con- or anoxia (the reduction of oxygen in trols). The device is exempt from the body tissues). premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to the limitations in § 862.9. premarket notification procedures in [52 FR 16122, May 1, 1987, as amended at 53 subpart E of part 807 of this chapter FR 21449, June 8, 1988; 66 FR 38788, July 25, subject to § 862.9. 2001] [52 FR 16122, May 1, 1987, as amended at 65 § 862.1645 Urinary protein or albumin FR 2308, Jan. 14, 2000] (nonquantitative) test system. (a) Identification. A urinary protein or § 862.1660 Quality control material (as- albumin (nonquantitative) test system sayed and unassayed). is a device intended to identify pro- (a) Identification. A quality control teins or albumin in urine. Identifica- material (assayed and unassayed) for tion of urinary protein or albumin clinical chemistry is a device intended (nonquantitative) is used in the diag- for medical purposes for use in a test nosis and treatment of disease condi- system to estimate test precision and tions such as renal or heart diseases or to detect systematic analytical devi- thyroid disorders, which are character- ations that may arise from reagent or ized by proteinuria or albuminuria. (b) Classification. Class I (general con- analytical instrument variation. A trols). The device is exempt from the quality control material (assayed and premarket notification procedures in unassayed) may be used for proficiency subpart E of part 807 of this chapter testing in interlaboratory surveys. subject to § 862.9. This generic type of device includes controls (assayed and unassayed) for [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] blood gases, electrolytes, enzymes, multianalytes (all kinds), single (speci- § 862.1650 Pyruvate kinase test system. fied) analytes, or urinalysis controls. (a) Identification. A pyruvate kinase (b) Classification. Class I (general con- test system is a device intended to trols). Except when used in donor measure the activity of the enzyme screening tests, unassayed material is pyruvate kinase in erythrocytes (red exempt from the premarket notifica- blood cells). Measurements obtained by tion procedures in subpart E of part 807 this device are used in the diagnosis of this chapter subject to § 862.9. and treatment of various inherited [52 FR 16122, May 1, 1987, as amended at 65 anemias due to pyruvate kinase defi- FR 2308, Jan. 14, 2000] ciency or of acute leukemias.

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§ 862.1665 Sodium test system. type of device includes immunoassays (a) Identification. A sodium test sys- and chromatographic assays for tem is a device intended to measure so- tacrolimus. dium in serum, plasma, and urine. (b) Classification. Class II (special Measurements obtained by this device controls). The special control is ‘‘Class are used in the diagnosis and treat- II Special Controls Guidance Docu- ment of aldosteronism (excessive secre- ment: Cyclosporine and Tacrolimus As- tion of the hormone aldosterone), dia- says; Guidance for Industry and FDA.’’ betes insipidus (chronic excretion of See § 862.1(d) for the availability of this large amounts of dilute urine, accom- guidance document. panied by extreme thirst), adrenal hy- [67 FR 58329, Sept. 16, 2002] pertension, Addison’s disease (caused by destruction of the adrenal glands), § 862.1680 Testosterone test system. dehydration, inappropriate antidiuretic hormone secretion, or other diseases (a) Identification. A testosterone test involving electrolyte imbalance. system is a device intended to measure (b) Classification. Class II. testosterone (a male sex hormone) in serum, plasma, and urine. Measure- § 862.1670 Sorbitol dehydrogenase test ment of testosterone are used in the di- system. agnosis and treatment of disorders in- (a) Identification. A sorbitol dehydro- volving the male sex hormones genase test system is a device intended (androgens), including primary and sec- to measure the activity of the enzyme ondary hypogonadism, delayed or pre- sorbitol dehydrogenase in serum. Meas- cocious puberty, impotence in males urements obtained by this device are and, in females hirsutism (excessive used in the diagnosis and treatment of hair) and virilization (masculinization) liver disorders such as cirrhosis or due to tumors, polycystic ovaries, and acute hepatitis. adrenogenital syndromes. (b) Classification. Class I (general con- (b) Classification. Class I. trols). The device is exempt from the premarket notification procedures in [52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988] subpart E of part 807 of this chapter subject to the limitations in § 862.9. § 862.1685 Thyroxine-binding globulin [52 FR 16122, May 1, 1987, as amended at 53 test system. FR 21449, June 8, 1988; 66 FR 38788, July 25, (a) Identification. A thyroxine-binding 2001] globulin test system is a device in- § 862.1675 Blood specimen collection tended to measure thyroxine (thyroid)- device. binding globulin (TBG), a plasma pro- tein which binds thyroxine, in serum (a) Identification. A blood specimen and plasma. Measurements obtained by collection device is a device intended this device are used in the diagnosis for medical purposes to collect and to handle blood specimens and to separate and treatment of thyroid diseases. serum from nonserum (cellular) compo- (b) Classification. Class II. nents prior to further testing. This ge- neric type device may include blood § 862.1690 Thyroid stimulating hor- mone test system. collection tubes, vials, systems, serum separators, blood collection trays, or (a) Identification. A thyroid stimu- vacuum sample tubes. lating hormone test system is a device (b) Classification. Class II. intended to measure thyroid stimu- lating hormone, also known as thyrot- § 862.1678 Tacrolimus test system. rophin and thyrotrophic hormone, in (a) Identification. A tacrolimus test serum and plasma. Measurements of system is a device intended to quan- thyroid stimulating hormone produced titatively determine tacrolimus con- by the anterior pituitary are used in centrations as an aid in the manage- the diagnosis of thyroid or pituitary ment of transplant patients receiving disorders. therapy with this drug. This generic (b) Classification. Class II.

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§ 862.1695 Free thyroxine test system. of this chapter subject to the limita- tions in § 862.9. (a) Identification. A free thyroxine test system is a device intended to [52 FR 16122, May 1, 1987, as amended at 65 measure free (not protein bound) FR 62286, Oct. 18, 2000] thyroxine (thyroid hormone) in serum § 862.1715 Triiodothyronine uptake or plasma. Levels of free thyroxine in test system. plasma are thought to reflect the amount of thyroxine hormone avail- (a) Identification. A triiodothyronine able to the cells and may therefore de- uptake test system is a device intended termine the clinical metabolic status to measure the total amount of binding of thyroxine. Measurements obtained sites available for binding thyroid hor- mone on the thyroxine-binding pro- by this device are used in the diagnosis teins, thyroid-binding globulin, and treatment of thyroid diseases. thyroxine-binding prealbumin, and al- (b) Classification. Class II. bumin of serum and plasma. The device provides an indirect measurement of § 862.1700 Total thyroxine test system. thyrkoxine levels in serum and plasma. (a) Identification. A total thyroxine Measurements of triiodothyronine up- test system is a device intended to take are used in the diagnosis and measure total (free and protein bound) treatment of thyroid disorders. thyroxine (thyroid hormone) in serum (b) Classification. Class II. The device and plasma. Measurements obtained by is exempt from the premarket notifica- this device are used in the diagnosis tion procedures in subpart E of part 807 and treatment of thyroid diseases. of this chapter subject to the limita- (b) Classification. Class II. tions in § 862.9. [52 FR 16122, May 1, 1987, as amended at 64 § 862.1705 Triglyceride test system. FR 1124, Jan. 8, 1999] (a) Identification. A triglyceride test system is a device intended to measure § 862.1720 Triose phosphate isomerase triglyceride (neutral fat) in serum and test system. plasma. Measurements obtained by this (a) Identification. A triose phosphate device are used in the diagnosis and isomerase test system is a device in- treatment of patients with diabetes tended to measure the activity of the mellitus, nephrosis, liver obstruction, enzyme triose phosphate isomerase in other diseases involving lipid metabo- erythrocytes (red blood cells). Triose lism, or various endocrine disorders. phosphate isomerase is an enzyme im- (b) Classification. Class I (general portant in glycolysis (the energy-yield- controls). The device is exempt from ing conversion of glucose to lactic acid the premarket notification procedures in various tissues). Measurements ob- in subpart E of part 807 of this chapter tained by this device are used in the di- subject to § 862.9. agnosis and treatment of congenital triose phosphate isomerase enzyme de- [52 FR 16122, May 1, 1987, as amended at 65 ficiency, which causes a type of hemo- FR 2308, Jan. 14, 2000] lytic anemia. (b) Classification. Class I (general con- § 862.1710 Total triiodothyronine test trols). The device is exempt from the system. premarket notification procedures in (a) Identification. A total subpart E of part 807 subject to the triiodothyronine test system is a de- limitations in § 862.9. vice intended to measure the hormone [52 FR 16122, May 1, 1987, as amended at 53 triiodothyronine in serum and plasma. FR 21449, June 8, 1988; 66 FR 38788, July 25, Measurements obtained by this device 2001] are used in the diagnosis and treat- ment of thyroid diseases such as hyper- § 862.1725 Trypsin test system. thyroidism. (a) Identification. A trypsin test sys- (b) Classification. Class II. This device tem is a device intended to measure is exempt from the premarket notifica- the activity of trypsin (a pancreatic tion procedures in subpart E of part 807 enzyme important in for the

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breakdown of proteins) in blood and used in the diagnosis and treatment of other body fluids and in feces. Measure- calculi of the urinary tract. ments obtained by this device are used (b) Classification. Class I (general in the diagnosis and treatment of pan- controls). The device is exempt from creatic disease. the premarket notification procedures (b) Classification. Class I (general in subpart E of part 807 of this chapter controls). The device is exempt from subject to § 862.9. the premarket notification procedures [52 FR 16122, May 1, 1987, as amended at 65 in subpart E of part 807 of this chapter FR 2308, Jan. 14, 2000] subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 § 862.1785 Urinary urobilinogen (non- FR 2308, Jan. 14, 2000] quantitative) test system. (a) Identification. A urinary urobi- § 862.1730 Free tyrosine test system. linogen (nonquantitative) test system (a) Identification. A free tyrosine test is a device intended to detect and esti- system is a device intended to measure mate urobilinogen (a bile pigment deg- free tyrosine (an amono acid) in serum radation product of red cell hemo- and urine. Measurements obtained by globin) in urine. Estimations obtained this device are used in the diagnosis by this device are used in the diagnosis and treatment of diseases such as con- and treatment of liver diseases and he- genital tyrosinemia (a disease that can molytic (red cells) disorders. cause liver/kidney disorders) and as an (b) Classification. Class I (general adjunct to the measurement of controls). The device is exempt from phenylalanine in detecting congenital the premarket notification procedures phenylketonuria (a disease that can in subpart E of part 807 of this chapter cause brain damage). subject to § 862.9. (b) Classification. Class I. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1770 Urea nitrogen test system. (a) Identification. A urea nitrogen test § 862.1790 Uroporphyrin test system. system is a device intended to measure (a) Identification. A uroporphyrin test urea nitrogen (an end-product of nitro- system is a device intended to measure gen metabolism) in whole blood, uroporphyrin in urine. Measurements serum, plasma, and urine. Measure- obtained by this device are used in the ments obtained by this device are used diagnosis and treatment of porphyrias in the diagnosis and treatment of cer- (primarily inherited diseases associ- tain renal and metabolic diseases. ated with disturbed porphyrin metabo- (b) Classification. Class II. lism), lead poisoning, and other dis- eases characterized by alterations in § 862.1775 Uric acid test system. the heme pathway. (a) Identification. A uric acid test sys- (b) Classification. Class I (general con- tem is a device intended to measure trols). The device is exempt from the uric acid in serum, plasma, and urine. premarket notification procedures in Measurements obtained by this device subpart E of part 807 of this chapter are used in the diagnosis and treat- subject to § 862.9. ment of numerous renal and metabolic [52 FR 16122, May 1, 1987, as amended at 65 disorders, including renal failure, gout, FR 2308, Jan. 14, 2000] leukemia, psoriasis, starvation or other wasting conditions, and of pa- § 862.1795 Vanilmandelic acid test sys- tients receiving cytotoxic drugs. tem. (b) Classification. Class I. (a) Identification. A vanilmandelic acid test system is a device intended to § 862.1780 Urinary calculi (stones) test measure vanilmandelic acid in urine. system. Measurements of vanilmandelic acid (a) Identification. A urinary calculi obtained by this device are used in the (stones) test system is a device in- diagnosis and treatment of neuro- tended for the analysis of urinary blastoma, pheochromocytoma, and cer- calculi. Analysis of urinary calculi is tain hypertensive conditions.

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(b) Classification. Class I (general con- treatment of gastrointestinal mal- trols). The device is exempt from the absorption syndrome (a group of dis- premarket notification procedures in orders in which there is subnormal ab- subpart E of part 807 of this chapter sorption of dietary constituents and subject to § 862.9. thus excessive loss from the body of [52 FR 16122, May 1, 1987, as amended at 65 the nonabsorbed substances). FR 2308, Jan. 14, 2000] (b) Classification. Class I (general con- trols). The device is exempt from the § 862.1805 Vitamin A test system. premarket notification procedures in (a) Identification. A vitamin A test subpart E of part 807 of this chapter system is a device intended to measure subject to § 862.9. vitamin A in serum or plasma. Meas- [52 FR 16122, May 1, 1987, as amended at 65 urements obtained by this device are FR 2308, Jan. 14, 2000] used in the diagnosis and treatment of vitamin A deficiency conditions, in- § 862.1825 Vitamin D test system. cluding night blindness, or skin, eye, or (a) Identification. A vitamin D test intestinal disorders. system is a device intended for use in (b) Classification. Class I (general con- clinical laboratories for the quan- trols). The device is exempt from the titative determination of 25- premarket notification procedures in hydroxyvitamin D (25–OH–D) and other subpart E of part 807 of this chapter hydroxylated metabolites of vitamin D subject to § 862.9. in serum or plasma to be used in the [52 FR 16122, May 1, 1987, as amended at 65 assessment of vitamin D sufficiency. FR 2308, Jan. 14, 2000] (b) Classification. Class II (special controls). Vitamin D test systems must § 862.1810 Vitamin B12 test system. comply with the following special con- trols: (a) Identification. A vitamin B12 test system is a device intended to measure (1) Labeling in conformance with 21 CFR 809.10 and vitamin B12 in serum, plasma, and urine. Measurements obtained by this (2) Compliance with existing stand- device are used in the diagnosis and ards of the National Committee on treatment of anemias of gastro- Clinical Laboratory Standards. intestinal malabsorption. [63 FR 40366, July 29, 1998] (b) Classification. Class II.

§ 862.1815 Vitamin E test system. Subpart C—Clinical Laboratory Instruments (a) Identification. A vitamin E test system is a device intended to measure § 862.2050 General purpose laboratory vitamin E (tocopherol) in serum. Meas- equipment labeled or promoted for urements obtained by this device are a specific medical use. used in the diagnosis and treatment of (a) Identification. General purpose infants with vitamin E deficiency syn- laboratory equipment labeled or pro- drome. moted for a specific medical use is a (b) Classification. Class I (general con- device that is intended to prepare or trols). The device is exempt from the examine specimens from the human premarket notification procedures in body and that is labeled or promoted subpart E of part 807 subject to the for a specific medical use. limitations in § 862.9. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 53 trols). The device is identified in para- FR 21449, June 8, 1988; 66 FR 38788, July 25, graph (a) of this section and is exempt 2001] from the premarket notification proce- dures in subpart E of part 807 of this § 862.1820 Xylose test system. chapter subject to the limitations in (a) Identification. A xylose test sys- § 862.9. The device is also exempt from tem is a device intended to measure the current good manufacturing prac- xylose (a sugar) in serum, plasma, and tice regulations in part 820 of this urine. Measurements obtained by this chapter, with the exception of § 820.180, device are used in the diagnosis and with respect to general requirements

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