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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)

$ 862.1295 Folic acid test system.

(a) Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

(b) Classification. Class II. (52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988)

8862.1280 Estrone test system.

(a) Identification. An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.

(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.

8 862.1300 Follicle-stimulating hor

mone test system. (a) Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 8 862.9. (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)

$ 862.1285 Etiocholanolone test system.

(a) Identification. An etiocholanolone test system is a device intended to measure etiocholanolone in serum and urine. Etiocholanolone is a metabolic product of the hormone testosterone and is excreted in the urine. Etiocholanolone measurements are used in the diagnosis and treatment of disorders of the testes and ovaries.

(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 2306, Jan. 14, 2000)

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$ 862.1290 Fatty acids test system.

(a) Identification. A fatty acids test system is a device intended to measure fatty acids in plasma and serum. Measurements of fatty acids are used in the diagnosis and treatment of various disorders of lipid metabolism.

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

$ 862.1310 Galactose test system.

(a) Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.

(b) Classification. Class I.

(52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988)

8862.1315 Galactose-1-phosphate cluding severe liver and renal disease, uridyl transferase test system.

multiple myeloma, and other disorders (a) Identification. A galactose-1-phos- of blood globulins. phate uridyl transferase test system is (b) Classification. Class I (general cona device intended to measure the activ- trols). The device is exempt from the ity of the enzyme galactose-1-phos- premarket notification procedures in phate uridyl transferase in subpart E of part 807 of this chapter erythrocytes (red blood cells). Meas- subject to $862.9. urements of galactose-1-phosphate uridyl transferase are used in the diag

(52 FR 16122, May 1, 1987, as amended at 65 nosis and treatment of the hereditary

FR 2306, Jan. 14, 2000) disease galactosemia (disorder of galac

8862.1335 Glucagon test system. tose metabolism) in infants. (b) Classification. Class II.

(a) Identification. A glucagon test sys

tem is a device intended to measure 8 862.1320 Gastric acidity test system.

the pancreatic hormone glucagon in (a) Identification. A gastric acidity plasma and serum. Glucagon measuretest system is a device intended to ments are used in the diagnosis and measure the acidity of gastric fluid. treatment of patients with various disMeasurements of gastric acidity are orders of carbohydrate metabolism, inused in the diagnosis and treatment of

cluding diabetes mellitus, hypopatients with peptic ulcer, Zollinger

glycemia, and hyperglycemia. Ellison syndrome (peptic ulcer due to

(b) Classification. Class I (general congastrin-secreting tumor of the pan

trols). The device is exempt from the creas), and related gastric disorders. (b) Classification. Class I. The device

premarket notification procedures in is exempt from the premarket notifica

subpart E of part 807 of this chapter tion procedures in subpart E of part

subject to $862.9. 807.

(52 FR 16122, May 1, 1987, as amended at 65 (52 FR 16122, May 1, 1987, as amended at 53

FR 2306, Jan. 14, 2000] FR 21449, June 8, 1988]

$ 862.1340 Urinary glucose (non8 862.1325 Gastrin test system.

quantitative) test system. (a) Identification. A gastrin test sys- (a) Identification. A urinary glucose tem is a device intended to measure (nonquantitative) test system is a dethe hormone gastrin in plasma and vice intended to measure glucosuria serum. Measurements of gastrin are (glucose in urine). Urinary glucose used in the diagnosis and treatment of

(nonquantitative) measurements are patients with ulcers, pernicious ane- used in the diagnosis and treatment of mia, and the Zollinger-Ellison syn

carbohydrate metabolism disorders indrome (peptic ulcer due to a gastrin-se

cluding diabetes mellitus, hypocreting tumor of the pancreas).

glycemia, and hyperglycemia. (b) Classification. Class I (general con

(b) Classification. Class II. trols). The device is exempt from the premarket notification procedures in

8 862.1345 Glucose test system. subpart E of part 807 of this chapter subject to $862.9.

(a) Identification. A glucose test sys

tem is a device intended to measure (52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000)

glucose quantitatively in blood and

other body fluids. Glucose measure$ 862.1330 Globulin test system.

ments are used in the diagnosis and (a) Identification. A globulin test sys

treatment of carbohydrate metabolism tem is a device intended to measure

disorders including diabetes mellitus, globulins (proteins) in plasma and

neonatal hypoglycemia, and idiopathic serum. Measurements of globulin are

hypoglycemia, and of pancreatic islet used in the diagnosis and treatment of

cell carcinoma. patients with numerous illnesses in- (b) Classification. Class II.

$862.1360 Gamma-glutamyl

8862.1375 Histidine test system. transpeptidase and isoenzymes test

(a) Identification. A histidine test syssystem.

tem is a device intended to measure (a) Identification. A gamma-glutamyl free histidine (an amino acid) in plastranspeptidase and isoenzymes test ma and urine. Histidine measurements system is a device intended to measure are used in the diagnosis and treatthe activity of the enzyme gamma- ment of hereditary histidinemia charglutamyl transpeptidase (GGTP) in acterized by excess histidine in the plasma and serum. Gamma-glutamyl blood and urine often resulting in mentranspeptidase and isoenzymes meas- tal retardation and disordered speech urements are used in the diagnosis and development. treatment of liver diseases such as al- (b) Classification. Class I (general concoholic cirrhosis and primary and sec- trols). The device is exempt from the ondary liver tumors.

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 8862.9. (52 FR 16122, May 1, 1987, as amended at 65

$ 862.1377 Urinary homocystine (nonFR 2306, Jan. 14, 2000)

quantitative) test system.

(a) Identification. A urinary $862.1365 Glutathione test system. homocystine (nonquantitative) test (a) Identification. A glutathione test

system is a device intended to identify system is a device intended to measure

homocystine (an analogue of the amino glutathione (the tripeptide of glycine,

acid cystine) in urine. The identificacysteine, and glutamic acid) in

tion of urinary homocystine is used in

the diagnosis erythrocytes (red blood cells). Gluta

and treatment of thione measurements are used in the

homocystinuria (homosystine in diagnosis and treatment of certain urine), a heritable metabolic disorder drug-induced hemolytic (erythrocyte

which may cause mental retardation. destroying) anemias due to an inher

(b) Classification. Class II. ited enzyme deficiency.

$ 862.1380 Hydroxybutyric dehydro(b) Classification. Class I. The device

genase test system. is exempt from the premarket notification procedures in subpart E of part

(a) Identification. A hydroxybutyric 807.

dehydrogenase test system is a device

intended to measure the activity of the (52 FR 16122, May 1, 1987, as amended at 53

enzyme alpha-hydroxybı ric dehydroFR 21449, June 8, 1988)

genase (HBD) in plasma or serum. HBD

measurements are used in the diag8862.1370 Human growth hormone

nosis and treatment of myocardial intest system.

farction, renal damage (such as rejec(a) Identification. A human growth tion of transplants), certain hormone test system is a device in- hematological diseases (such as acute tended to measure the levels of human

leukemias and megaloblastic anemias) growth hormone in plasma. Human and, to a lesser degree, liver disease. growth hormone measurements are (b) Classification. Class I. The device used in the diagnosis and treatment of is exempt from the premarket notificadisorders involving the anterior lobe of tion procedures in subpart E of part the pituitary gland.

807. (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) premarket notification procedures in subpart E of part 807 of this chapter 8862.1385 17-Hydroxycorticosteroids subject to 8 862.9.

(17-ketogenic steroids) test system. (52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A 17-hydroxyFR 2306, Jan. 14, 2000]

corticosteroids (17-ketogenic steroids)

(HOCH2 - C-CH2OH)

test system is a device intended to (b) Classification. Class I (general conmeasure corticosteroids that possess a trols). The device is exempt from the dihydroxyacetone

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.

8 862.1400 Hydroxyproline test system. Corticosteroids with this chemical configuration include cortisol, cortisone

(a) Identification. A hydroxyproline 11-desoxycortisol,

test system is a device intended to and their

measure the desoxycorticosterone,

amino acid

in hydroxyproline

urine. tetrahydroderivatives. This group of hormones is synthesized by the adrenal Hydroxyproline measurements are used gland. Measurements of 17-hydroxy

in the diagnosis and treatment of varcorticosteroids (17-ketogenic steroids)

ious collagen (connective tissue) disare used in the diagnosis and treat

eases, bone disease such as Paget's disment of various diseases of the adrenal

ease, and endocrine disorders such as

hyperparathyroidism and or, pituitary glands and gonadal dis

hyperorders.

thyroidism.

(b) Classification. Class I (general con(b) Classification. Class I (general controls). 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 8 862.9.

(52 FR 16122, May 1, 1987, as amended at 65 (52 FR 16122, May. 1, 1987; 52 FR 29468, Aug. 7,

FR 2306, Jan. 14, 2000] 1987, as amended at 65 FR 2306, Jan. 14, 2000)

862.1405 Immunoreactive insulin test $ 862.1390 5-Hydroxyindole acetic acid/

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 inhydroxyindole acetic acid/serotonin in sulin measurements are used in the diurine. Measurements of 5

agnosis and treatment of various carhydroxyindole acetic acid/serotonin are

bohydrate metabolism disorders, inused in the diagnosis and treatment of

cluding diabetes mellitus, and hypocarcinoid tumors of endocrine tissue.

glycemia. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). 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 8 862.9. (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)

8862.1395 17-Hydroxyprogesterone

test system. (a) Identij on. A 17hydroxyprogesterone test system is a device intended to measure 17hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.

8862.1410 Iron (non-heme) test system.

(a) Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and

hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

(b) Classification. Class I.

$862.1415 Iron-binding capacity test

system. (a) Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

(b) Classification. Class I.

8 862.1435 Ketones (nonquantitative)

test system. (a) Identification. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.

(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.

in

(52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000)

8862.1420 Isocitric dehydrogenase test

system. (a) Identification. An isocitric dehydrogenase test system is a device intended to measure the activity of the enzyme

isocitric dehydrogenase serum and plasma. Isocitric dehydrogenase measurements are used in the diagnosis and treatment of liver disease such as viral hepatitis, cirrhosis, or acute inflammation of the biliary tract; pulmonary disease such as pulmonary infarction (local arrest sudden insufficiency of the blood supply to the lungs), and diseases associated with pregnancy.

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

8862.1440 Lactate dehydrogenase test

system. (a) Identification. A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

(b) Classification. Class II (special 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 53 FR 21449, June 8, 1988)

(52 FR 16122, May 1, 1987, as amended at 63 FR 59225, Nov. 3, 1998]

8862.1430 17-ketosteroids test system.

(a) Identification. A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17-ketosteroids are used in the diagnosis and treatment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including hypertension, diabetes, and hypothyroidism.

(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 2307, Jan. 14, 2000)

$ 862.1445 Lactate dehydrogenase

isoenzymes test system. (a) Identification. A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.

(b) Classification. Class II.

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