§ 864.7100 21 CFR Ch. I (4–1–12 Edition)

(b) Classification. Class II (perform- (that fraction of the plasma responsible ance standards). for the formation of , a clot lysing enzyme). This test evaluates [45 FR 60609, Sept. 12, 1980] natural (destruction of a § 864.7100 enzyme blood clot after bleeding has been ar- assay. rested). The test also will detect accel- erated fibrinolysis. (a) Identification. Red blood cell en- (b) Classification. Class II (perform- zyme assay is a device used to measure ance standards). the activity in red blood cells of clini- cally important enzymatic reactions [45 FR 60612, Sept. 12, 1980] and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red § 864.7280 Factor V Leiden DNA muta- blood cell enzyme assay is used to de- tion detection systems. termine the enzyme defects responsible (a) Identification. Factor V Leiden for a patient’s hereditary hemolytic deoxyribonucleic acid (DNA) mutation anemia. detection systems are devices that con- (b) Classification. Class II (perform- sist of different reagents and instru- ance standards). ments which include polymerase chain [45 FR 60610, Sept. 12, 1980] reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, § 864.7140 Activated whole blood clot- and software packages. The detection ting time tests. of the Factor V Leiden mutation aids (a) Identification. An activated whole in the diagnosis of patients with sus- blood clotting time tests is a device, pected thrombophilia. used to monitor heparin therapy for (b) Classification. Class II (special the treatment of venous thrombosis or controls). The special control is FDA’s pulmonary embolism by measuring the guidance entitled ‘‘Class II Special time of whole blood. Controls Guidance Document: Factor V (b) Classification. Class II (perform- Leiden DNA Mutation Detection Sys- ance standards). tems.’’ (See § 864.1(d) for the avail- ability of this guidance document.) [45 FR 60611, Sept. 12, 1980] [69 FR 12273, Mar. 16, 2004] § 864.7250 Erythropoietin assay. § 864.7290 Factor deficiency test. (a) Identification. A erythropoietin assay is a device that measures the (a) Identification. A factor deficiency concentration of erythropoietin (an en- test is a device used to diagnose spe- zyme that regulates the production of cific coagulation defects, to monitor red blood cells) in serum or urine. This certain types of therapy, to detect co- assay provides diagnostic information agulation inhibitors, and to detect a for the evaluation of erythrocytosis carrier state (a person carrying both a (increased total red cell mass) and ane- recessive gene for a coagulation factor mia. deficiency such as hemophilia and the (b) Classification. Class II. The special corresponding normal gene). control for this device is FDA’s ‘‘Docu- (b) Classification. Class II (perform- ment for Special Controls for Erythro- ance standards). poietin Assay Premarket Notification [45 FR 60613, Sept. 12, 1980] (510(k)s).’’ [45 FR 60612, Sept. 12, 1980, as amended at 52 § 864.7300 Fibrin monomer FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, paracoagulation test. 2000] (a) Identification. A fibrin monomer paracoagulation test is a device used to § 864.7275 Euglobulin lysis time tests. detect fibrin monomer in the diagnosis (a) Identification. A euglobulin lysis of disseminated intravascular coagula- time test is a device that measures the tion (nonlocalized clotting within a length of time required for the lysis blood vessel) or in the differential diag- (dissolution) of a clot formed from nosis between disseminated in the euglobulin fraction intravascular coagulation and primary

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fibrinolysis (dissolution of the fibrin in phate dehydrogenase deficiency. This a blood clot). generic device includes assays based on (b) Classification. Class II. The special fluorescence, electrophoresis, control for this device is FDA’s ‘‘In methemoglobin reduction, catalase in- Vitro Diagnostic Fibrin Monomer hibition, and ultraviolet kinetics. Paracoagulation Test.’’ (b) Classification. Class II (perform- [45 FR 60614, Sept. 12, 1980, as amended at 52 ance standards). FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, [45 FR 60616, Sept. 12, 1980] 2000] § 864.7375 Glutathione reductase § 864.7320 Fibrinogen/fibrin degrada- assay. tion products assay. (a) Identification. A glutathione re- (a) Identification. A fibrinogen/fibrin ductase assay is a device used to deter- degradation products assay is a device mine the activity of the enzyme gluta- used to detect and measure fibrinogen thione reductase in serum, plasma, or degradation products and fibrin deg- erythrocytes by such techniques as flu- radation products (protein fragments orescence and photometry. The results produced by the enzymatic action of of this assay are used in the diagnosis plasmin on fibrinogen and fibrin) as an of liver disease, glutathione reductase aid in detecting the presence and de- deficiency, or riboflavin deficiency. gree of intravascular coagulation and (b) Classification. Class II (perform- fibrinolysis (the dissolution of the ance standards). fibrin in a blood clot) and in moni- toring therapy for disseminated [45 FR 60616, Sept. 12, 1980] intravascular coagulation (nonlocal- ized clotting in the blood vessels). § 864.7400 A2 assay. (b) Classification. Class II (perform- (a) Identification. A hemoglobin A2 ance standards). assay is a device used to determine the [45 FR 60615, Sept. 12, 1980] hemoglobin A2 content of human blood. The measurement of hemoglobin A2 is § 864.7340 Fibrinogen determination used in the diagnosis of the system. thalassemias (hereditary hemolytic (a) Identification. A fibrinogen deter- anemias characterized by decreased mination system is a device that con- synthesis of one or more types of he- sists of the instruments, reagents, moglobin polypeptide chains). standards, and controls used to deter- (b) Classification. Class II (perform- mine the fibrinogen levels in dissemi- ance standards). nated intravascular coagulation (non- [45 FR 60617, Sept. 12, 1980] localized clotting within the blood ves- sels) and primary fibrinolysis (the dis- § 864.7415 Abnormal hemoglobin assay. solution of fibrin in a blood clot). (b) Classification. Class II (perform- (a) Identification. An abnormal hemo- ance standards). globin assay is a device consisting of the reagents, apparatus, instrumenta- [45 FR 60615, Sept. 12, 1980] tion, and controls necessary to isolate and identify abnormal genetically de- § 864.7360 Erythrocytic glucose-6-phos- termined hemoglobin types. phate dehydrogenase assay. (b) Classification. Class II (perform- (a) Identification. An erythrocytic ance standards). glucose-6-phosphate dehydrogenase assay is a device used to measure the [45 FR 60618, Sept. 12, 1980] activity of the enzyme glucose-6-phos- phate dehydrogenase or of glucose-6- § 864.7425 Carboxyhemoglobin assay. phosphate dehydrogenase isoenzymes. (a) Identification. A The results of this assay are used in carboxyhemoglobin assay is a device the diagnosis and treatment of used to determine the nonspherocytic congenital hemolytic carboxyhemoglobin (the compound anemia or drug-induced hemolytic ane- formed when hemoglobin is exposed to mia associated with a glucose-6-phos- carbon monoxide) content of human

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