224 Subpart H—Hematology Kits and Packages
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§ 864.7040 21 CFR Ch. I (4–1–02 Edition) Subpart H—Hematology Kits and the treatment of venous thrombosis or Packages pulmonary embolism by measuring the coagulation time of whole blood. § 864.7040 Adenosine triphosphate re- (b) Classification. Class II (perform- lease assay. ance standards). (a) Identification. An adenosine [45 FR 60611, Sept. 12, 1980] triphosphate release assay is a device that measures the release of adenosine § 864.7250 Erythropoietin assay. triphosphate (ATP) from platelets fol- (a) Identification. A erythropoietin lowing aggregation. This measurement assay is a device that measures the is made on platelet-rich plasma using a concentration of erythropoietin (an en- photometer and a luminescent firefly zyme that regulates the production of extract. Simultaneous measurements red blood cells) in serum or urine. This of platelet aggregation and ATP re- assay provides diagnostic information lease are used to evaluate platelet for the evaluation of erythrocytosis function disorders. (increased total red cell mass) and ane- (b) Classification. Class I (general mia. controls). (b) Classification. Class II. The special [45 FR 60609, Sept. 12, 1980] control for this device is FDA’s ‘‘Docu- ment for Special Controls for Erythro- § 864.7060 Antithrombin III assay. poietin Assay Premarket Notification (a) Identification. An antithrombin III (510(k)s).’’ assay is a device that is used to deter- [45 FR 60612, Sept. 12, 1980, as amended at 52 mine the plasma level of antithrombin FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, III (a substance which acts with the 2000] anticoagulant heparin to prevent co- agulation). This determination is used § 864.7275 Euglobulin lysis time tests. to monitor the administration of hep- (a) Identification. A euglobulin lysis arin in the treatment of thrombosis. time test is a device that measures the The determination may also be used in length of time required for the lysis the diagnosis of thrombophilia (a con- (dissolution) of a clot formed from genital deficiency of antithrombin III). fibrinogen in the euglobulin fraction (b) Classification. Class II (perform- (that fraction of the plasma responsible ance standards). for the formation of plasmin, a clot [45 FR 60609, Sept. 12, 1980] lysing enzyme). This test evaluates natural fibrinolysis (destruction of a § 864.7100 Red blood cell enzyme blood clot after bleeding has been ar- assay. rested). The test also will detect accel- (a) Identification. Red blood cell en- erated fibrinolysis. zyme assay is a device used to measure (b) Classification. Class II (perform- the activity in red blood cells of clini- ance standards). cally important enzymatic reactions and their products, such as pyruvate [45 FR 60612, Sept. 12, 1980] kinase or 2,3-diphosphoglycerate. A red § 864.7290 Factor deficiency test. blood cell enzyme assay is used to de- termine the enzyme defects responsible (a) Identification. A factor deficiency for a patient’s hereditary hemolytic test is a device used to diagnose spe- anemia. cific coagulation defects, to monitor (b) Classification. Class II (perform- certain types of therapy, to detect co- ance standards). agulation inhibitors, and to detect a carrier state (a person carrying both a [45 FR 60610, Sept. 12, 1980] recessive gene for a coagulation factor § 864.7140 Activated whole blood clot- deficiency such as hemophilia and the ting time tests. corresponding normal gene). (b) Classification. Class II (perform- (a) Identification. An activated whole ance standards). blood clotting time tests is a device, used to monitor heparin therapy for [45 FR 60613, Sept. 12, 1980] 224 VerDate Apr<18>2002 06:36 Apr 28, 2002 Jkt 197069 PO 00000 Frm 00224 Fmt 8010 Sfmt 8010 Y:\SGML\197069T.XXX pfrm12 PsN: 197069T Food and Drug Administration, HHS § 864.7415 § 864.7300 Fibrin monomer § 864.7360 Erythrocytic glucose-6-phos- paracoagulation test. phate dehydrogenase assay. (a) Identification. A fibrin monomer (a) Identification. An erythrocytic paracoagulation test is a device used to glucose-6-phosphate dehydrogenase detect fibrin monomer in the diagnosis assay is a device used to measure the of disseminated intravascular coagula- activity of the enzyme glucose-6-phos- tion (nonlocalized clotting within a phate dehydrogenase or of glucose-6- blood vessel) or in the differential diag- phosphate dehydrogenase isoenzymes. nosis between disseminated The results of this assay are used in intravascular coagulation and primary the diagnosis and treatment of fibrinolysis (dissolution of the fibrin in nonspherocytic congenital hemolytic a blood clot). anemia or drug-induced hemolytic ane- mia associated with a glucose-6-phos- (b) Classification. Class II. The special phate dehydrogenase deficiency. This control for this device is FDA’s ‘‘In generic device includes assays based on Vitro Diagnostic Fibrin Monomer fluorescence, electrophoresis, Paracoagulation Test.’’ methemoglobin reduction, catalase in- [45 FR 60614, Sept. 12, 1980, as amended at 52 hibition, and ultraviolet kinetics. FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, (b) Classification. Class II (perform- 2000] ance standards). § 864.7320 Fibrinogen/fibrin degrada- [45 FR 60616, Sept. 12, 1980] tion products assay. § 864.7375 Glutathione reductase (a) Identification. A fibrinogen/fibrin assay. degradation products assay is a device (a) Identification. A glutathione re- used to detect and measure fibrinogen ductase assay is a device used to deter- degradation products and fibrin deg- mine the activity of the enzyme gluta- radation products (protein fragments thione reductase in serum, plasma, or produced by the enzymatic action of erythrocytes by such techniques as flu- plasmin on fibrinogen and fibrin) as an orescence and photometry. The results aid in detecting the presence and de- of this assay are used in the diagnosis gree of intravascular coagulation and of liver disease, glutathione reductase fibrinolysis (the dissolution of the deficiency, or riboflavin deficiency. fibrin in a blood clot) and in moni- (b) Classification. Class II (perform- toring therapy for disseminated ance standards). intravascular coagulation (nonlocal- ized clotting in the blood vessels). [45 FR 60616, Sept. 12, 1980] (b) Classification. Class II (perform- § 864.7400 Hemoglobin A2 assay. ance standards). (a) Identification. A hemoglobin A2 [45 FR 60615, Sept. 12, 1980] assay is a device used to determine the hemoglobin A2 content of human blood. § 864.7340 Fibrinogen determination The measurement of hemoglobin A2 is system. used in the diagnosis of the (a) Identification. A fibrinogen deter- thalassemias (hereditary hemolytic mination system is a device that con- anemias characterized by decreased sists of the instruments, reagents, synthesis of one or more types of he- standards, and controls used to deter- moglobin polypeptide chains). mine the fibrinogen levels in dissemi- (b) Classification. Class II (perform- nated intravascular coagulation (non- ance standards). localized clotting within the blood ves- [45 FR 60617, Sept. 12, 1980] sels) and primary fibrinolysis (the dis- solution of fibrin in a blood clot). § 864.7415 Abnormal hemoglobin assay. (b) Classification. Class II (perform- (a) Identification. An abnormal hemo- ance standards). globin assay is a device consisting of [45 FR 60615, Sept. 12, 1980] the reagents, apparatus, instrumenta- tion, and controls necessary to isolate 225 VerDate Apr<18>2002 06:36 Apr 28, 2002 Jkt 197069 PO 00000 Frm 00225 Fmt 8010 Sfmt 8010 Y:\SGML\197069T.XXX pfrm12 PsN: 197069T § 864.7425 21 CFR Ch. I (4–1–02 Edition) and identify abnormal genetically de- (b) Classification. Class II (perform- termined hemoglobin types. ance standards). (b) Classification. Class II (perform- [45 FR 60620, Sept. 12, 1980] ance standards). [45 FR 60618, Sept. 12, 1980] § 864.7470 Glycosylated hemoglobin assay. § 864.7425 Carboxyhemoglobin assay. (a) Identification. A glycosylated he- (a) Identification. A carboxy- moglobin assay is a device used to hemoglobin assay is a device used to measure the glycosylated hemoglobins determine the carboxyhemoglobin (the (A1a, A1b, and A1c) in a patient’s blood compound formed when hemoglobin is by a column chromatographic proce- exposed to carbon monoxide) content of dure. Measurement of glycosylated he- human blood as an aid in the diagnosis moglobin is used to assess the level of of carbon monoxide poisoning. This control of a patient’s diabetes and to measurement may be made using determine the proper insulin dosage for methods such as spectroscopy, colorim- a patient. Elevated levels of etry, spectrophotometry, and glycosylated hemoglobin indicate un- gasometry. controlled diabetes in a patient. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). [45 FR 60619, Sept. 12, 1980] [45 FR 60621, Sept. 12, 1980] § 864.7440 Electrophoretic hemoglobin § 864.7490 Sulfhemoglobin assay. analysis system. (a) Identification. A sulfhemoglobin (a) Identification. An electrophoretic assay is a device consisting of the re- hemoglobin analysis system is a device agents, calibrators, controls, and in- that electrophoretically separates and strumentation used to determine the identifies normal and abnormal hemo- sulfhemoglobin (a compound of sulfur globin types as an aid in the diagnosis and hemoglobin) content of human of anemia or erythrocytosis (increased blood as an aid in the diagnosis of total red cell mass) due to a hemo- sulfhemoglobinemia (presence of globin abnormality. sulfhemoglobin in