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(a)

8862.1117 B-type natriuretic peptide test system.

Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

(b) Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.” [66 FR 12734, Feb. 28, 2001)

ease 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)

8862.1135 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)

8 862.1118 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) 8862.1120 Blood gases (Pc02, P.2) and

blood pH test system. (a) Identification. A blood gases (Pco2, P.2) 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, P.2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

(b) Classification. Class II. 8 862.1130 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 dis

8862.1140 Calcitonin test system.

(a) Identification. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

(b) Classification. Class II.

$ 862.1145 Calcium test system.

(a) Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

(b) Classification. Class II.

$ 862.1150 Calibrator.

$ 862.1165 Catecholamines (total) test

system. (a) Identification. A calibrator is a device intended for medical purposes for (a) Identification. A catecholamines use in a test system to establish points

(total) test system is a device intended of reference that are used in the deter

to determine whether a group of simimination of values in the measurement

lar compounds (epinephrine, of substances in human specimens. (See

norepinephrine, and dopamine) are also $862.2 in this part.)

present in urine and plasma.

Catecholamine determinations are (b) Classification. Class II.

used in the diagnosis and treatment of $862.1155 Human

chorionic

adrenal medulla and hypertensive disgonadotropin (HCG) test system.

orders, and for catecholamine-secret

ing tumors (pheochromo-cytoma, neu(a) Human chorionic gonadotropin roblastoma, ganglioneuroma, and (HCG) test system intended for the early retinoblastoma). detection of pregnancy—(1) Identification. (b) Classification. Class I (general conA human chorionic gonadotropin (HCG) trols). The device is exempt from the test system is a device intended for the premarket notification procedures in early detection of pregnancy is in- subpart E of part 807 of this chapter tended to measure HCG, a placental subject to $862.9. hormone, in plasma or urine.

(52 FR 16122, May 1, 1987, as amended at 65 (2) Classification. Class II.

FR 2305, Jan. 14, 2000) (b) Human chorionic gonadotropin (HCG) test system intended for any uses 8862.1170 Chloride test system. other than early detection of pregnancy

(a) Identification. A chloride test sys(1) Identification. A human chorionic

tem is a device intended to measure goadotropin (HCG) test system is a de

the level of chloride in plasma, serum, vice intended for any uses other than

sweat, and urine. Chloride measureearly detection of pregnancy (such as ments are used in the diagnosis and an aid in the diagnosis, prognosis, and treatment of electrolyte and metabolic management of treatment of persons disorders such as cystic fibrosis and diwith certain tumors or carcinomas) is abetic acidosis. intended to measure HCG, a placental (b) Classification. Class II. hormone, in plasma or urine. (2) Classification. Class III.

8862.1175 Cholesterol (total) test sys

tem. (3) Date PMA or notice of completion of a PDP is required. As of the enactment (a) Identification. A cholesterol (total) date of the amendments, May 28, 1976, test system is a device intended to an approval under section 515 of the act measure cholesterol in plasma and is required before the device described serum. Cholesterol measurements are in paragraph (b)(1) may be commer

used in the diagnosis and treatment of cially distributed. See 8862.3.

disorders involving excess cholesterol

in the blood and lipid and lipoprotein 8862.1160 Bicarbonate/carbon dioxide metabolism disorders. test system.

(b) Classification. Class I (general con(a) Identification. A bicarbonate/car

trols). The device is exempt from the bon dioxide test system is a device in

premarket notification procedures 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

$ 862.1177 Cholylglycine test system. tentially serious disorders associated 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

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 8 862.9.

8 862.1190 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)

(52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000)

$ 862.1185 Compound S (11.

deoxycortisol) test system. (a) Identification. A compound S (11dioxycortisol) test system is a device intended to measure the level of compound S (11-dioxycortisol) in plasma. Compound s is a steroid intermediate in the biosynthesis of the adrenal hormone cortisol. Measurements of compound s are used in the diagnosis and treatment of certain adrenal and pituitary gland disorders resulting in clinical 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 8 862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000)

$862.1195 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)

§ 862.1187 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.

8862.1200 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 8 862.9.

(52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000)

$862.1205 Cortisol (hydrocortisone

and hydroxycorticosterone) test

system. (a) Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

(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, 5monophosphate (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.

8862.1210 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.

in

$ 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 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 8 862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000)

[blocks in formation]

8862.1245 Dehydroepiandrosterone

(free and sulfate) test system. (a) Identification.

A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

(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 8862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000)

8862.1225 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.

194-069 D-01-7

(a)

measure

$ 862.1250 Desoxycorticosterone test 8 862.1265 Estriol test system. system.

(a) Identification. An estriol test sys(a) Identification.

A tem is a device intended to measure esdesoxycorticosterone test system is a triol, an estrogenic steroid, in plasma, device intended to measure serum, and urine of pregnant females. desoxycorticosterone (DOC) in plasma Estriol measurements are used in the and urine. DOC measurements are used diagnosis and treatment of in the diagnosis and treatment of pa- fetoplacental distress in certain cases tients with hypermineralocorticoidism of high-risk pregnancy. (excess retention of sodium and loss of (b) Classification. Class I (general conpotassium) and other disorders of the trols). The device is exempt from the adrenal gland.

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.

$ 862.1270 Estrogens (total, in preg. (52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000)

nancy) test system.

(a) Identification. As estrogens (total, 8862.1255 2,3-Diphosphoglyceric acid in pregnancy) test system is a device test system.

intended to measure total estrogens in Identification. А 2,3- plasma, serum, and urine during preg. diphosphoglyceric acid test system is a nancy. The device primarily measures device intended to

2,3

estrone plus estradiol. Measurements diphosphoglyceric acid (2,3-DPG) in of total estrogens are used to aid in the erythrocytes (red blood cells). Meas

diagnosis and treatment of urements of 2,3-diphosphoglyceric acid

fetoplacental distress in certain cases are used in the diagnosis and treat

of high-risk pregnancy. ment of blood disorders that affect the (b) Classification. Class I (general condelivery of oxygen by erythrocytes to trols). The device is exempt from the tissues and in monitoring the quality premarket notification procedures in of stored blood.

subpart E of part 807 of this chapter (b) Classification. Class I. The device subject to $ 862.9. is exempt from the premarket notifica

(52 FR 16122, May 1, 1987, as amended at 65 tion procedures in subpart E of part FR 2306, Jan. 14, 2000] 807.

8862.1275 Estrogens (total, nonpreg. (52 FR 16122, May 1, 1987, as amended at 53

nancy) test system. FR 21449, June 8, 1988]

(a) Identification. As estrogens (total, 8 862.1260 Estradiol test system.

nonpregnancy) test system is a device

intended to measure the level of estro(a) Identification. An estradiol test system is a device intended to measure

gens (total estrone, estradiol, and esestradiol, estrogenic steroid, in

triol) in plasma, serum, and urine of plasma. Estradiol measurements are

males and nonpregnant females. Meas

urement of estrogens (total, nonpregused in the diagnosis and treatment of various hormonal sexual disorders and

nancy) is used in the diagnosis and

treatment of numerous disorders, inin assessing placental function in com

cluding infertility, amenorrhea (abplicated pregnancy.

sence of menses) differentiation of pri(b) Classification. Class I (general con

mary and secondary ovarian malfunctrols). The device is exempt from the

tion, estrogen secreting testicular and premarket notification procedures in ovarian tumors, and precocious pusubpart E of part 807 of this chapter

berty in females. 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 2306, Jan. 14, 2000]

premarket notification procedures in

an

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