§ 864.7040 21 CFR Ch. I (4–1–02 Edition)

Subpart H— Kits and the treatment of or Packages by measuring the 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 fol- (a) Identification. A erythropoietin lowing aggregation. This measurement assay is a device that measures the is made on -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). in the euglobulin fraction (b) Classification. Class II (perform- (that fraction of the plasma responsible ance standards). for the formation of , a clot [45 FR 60609, Sept. 12, 1980] lysing enzyme). This test evaluates natural (destruction of a § 864.7100 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- . 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 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]

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§ 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 ( 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 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- (hereditary hemolytic mination system is a device that con- 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

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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 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- (presence of globin abnormality. sulfhemoglobin in the blood due to (b) Classification. Class II (perform- drug administration or exposure to a ance standards). poison). This measurement may be [45 FR 60620, Sept. 12, 1980] made using methods such as spectros- copy, colorimetry, spectrophotometry, § 864.7455 Fetal hemoglobin assay. or gasometry. (b) Classification. Class II (perform- (a) Identification. A fetal hemoglobin assay is a device that is used to deter- ance standards). mine the presence and distribution of [45 FR 60621, Sept. 12, 1980] fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal § 864.7500 Whole blood hemoglobin as- hemoglobin present. The assay may be says. used to detect fetal red cells in the ma- (a) Identification. A whole blood he- ternal circulation or to detect the ele- moglobin assay is a device consisting vated levels of fetal hemoglobin exhib- or reagents, calibrators, controls, or ited in cases of hemoglobin abnormali- photometric or spectrophotometric in- ties such as (a hereditary strumentation used to measure the he- characterized by a moglobin content of whole blood for decreased synthesis of one or more the detection of anemia. This generic types of hemoglobin polypeptide device category does not include auto- chains). The hemoglobin determination mated hemoglobin systems. may be made by methods such as elec- (b) Classification. Class II (perform- trophoresis, alkali denaturation, col- ance standards). umn chromatography, or radial immunodiffusion. [45 FR 60622, Sept. 12, 1980]

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§ 864.7525 Heparin assay. premarket notification procedures in (a) Identification. A heparin assay is a subpart E of part 807 of this chapter device used to determine the level of subject to the limitations in § 864.9. the anticoagulant heparin in the pa- [45 FR 60624, Sept. 12, 1980, as amended at 59 tient’s circulation. These assays are FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, quantitative clotting time procedures 2001] using the effect of heparin on activated coagulation factor X (Stuart factor) or § 864.7695 Platelet factor 4 procedures based on the neutralization radioimmunoassay. of heparin by protamine sulfate (a pro- (a) Identification. A platelet factor 4 tein that neutralizes heparin). radioimmunoassay is a device used to (b) Classification. Class II (perform- measure the level of platelet factor 4, a ance standards). protein released during platelet activa- [45 FR 60623, Sept. 12, 1980] tion by radioimmunoassay. This device measures platelet activiation, which § 864.7660 Leukocyte alkaline phos- may indicate a coagulation disorder, phatase test. such as myocardial infarction or coro- (a) Identification. A leukocyte alka- nary artery disease. line phosphatase test is a device used (b) Classification. Class II (perform- to identify the enzyme leukocyte alka- ance standards). line phosphatase in neutrophilic granulocytes (granular leukocytes [45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. stainable by neutral dyes). The 3, 1981] cytochemical identification of alkaline phosphatase depends on the formation § 864.7720 Prothrombin consumption of blue granules in cells containing al- test. kaline phosphatase. The results of this (a) Identification. A prothrombin con- test are used to differentiate chronic sumption tests is a device that meas- granulocytic leukemia (a malignant ures the patient’s capacity to generate disease characterized by excessive thromboplastin in the coagulation overgrowth of granulocytes in the bone process. The test also is an indirect in- marrow) and reactions that resemble dicator of qualitative or quantitative true leukemia, such as those occuring platelet abnormalities. It is a screen- in severe infections and ing test for thrombocytopenia (de- (increased total red cell mass). creased number of blood platelets) and (b) Classification. Class I (general con- hemophilia A and B. trols). This device is exempt from the (b) Classification. Class II (perform- premarket notification procedures in ance standards). subpart E of part 807 of this chapter subject to the limitations in § 864.9. [45 FR 60625, Sept. 12, 1980] [45 FR 60623, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, § 864.7735 Prothrombin-proconvertin 2001] test and thrombotest. (a) Identification. The prothrombin- § 864.7675 Leukocyte peroxidase test. proconvertin test and thrombotest are (a) Identification. A leukocyte peroxi- devices used in the regulation of cou- dase test is a device used to distinguish marin therapy (administration of a certain myeloid cells derived from the coumarin anticoagulant such as so- bone marrow, i.e., neutrophils, dium warfarin in the treatment of ve- eosinophils, and monocytes, from nous thrombosis and pulmonary embo- lymphoid cells of the lymphatic system lism) and as a diagnostic test in con- and erythroid cells of the red blood cell junction with, or in place of, the Quick series on the basis of their peroxidase test to detect coagu- activity as evidenced by staining. The lation disorders. results of this test are used in the dif- (b) Classification. Class II (perform- ferential diagnosis of the leukemias. ance standards). (b) Classification. Class I (general con- trols). This device is exempt from the [45 FR 60626, Sept. 12, 1980]

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§ 864.7750 Prothrombin time test. normalities, for evaluation of the ef- (a) Identification. A prothrombin time fect of therapy on procoagulant dis- test is a device used as a general orders, and as an assay for coagulation screening procedure for the detection factor deficiencies of the intrinsic co- of possible clotting factor deficiencies agulation pathway. in the extrinsic coagulation pathway, (b) Classification. Class II (perform- which involves the reaction between ance standards). coagulation factors III and VII, and to [45 FR 60629, Sept. 12, 1980] monitor patients receiving coumarin therapy (the administration of one of Subpart I—Hematology Reagents the coumarin anticoagulants in the treatment of venous thrombosis or pul- § 864.8100 Bothrops atrox reagent. monary embolism). (a) Identification. A Bothrops atrox (b) Classification. Class II (perform- reagent is a device made from snake ance standards). venom and used to determine blood [45 FR 60626, Sept. 12, 1980] fibrinogen levels to aid in the evalua- tion of disseminated intravascular co- § 864.7825 Sickle cell test. agulation (nonlocalized clotting in the (a) Identification. A sickle cell test is blood vessels) in patients receiving a device used to determine the sickle heparin therapy (the administration of cell hemoglobin content of human the anticoagulant heparin in the treat- blood to detect sickle cell trait or sick- ment of thrombosis) or as an aid in the le cell diseases. classification of dysfibrinogenemia (b) Classification. Class II (perform- (presence in the plasma of functionally ance standards). defective fibrinogen). (b) Classification. Class II (perform- [45 FR 60627, Sept. 12, 1980] ance standards). § 864.7875 test. [45 FR 60629, Sept. 12, 1980] (a) Identification. A thrombin time test is a device used to measure § 864.8150 Calibrator for cell indices. fibrinogen concentration and detect (a) Identification. A calibrator for cell fibrin or fibrinogen split products for indices is a device that approximates the evaluation of bleeding disorders. whole blood or certain blood cells and (b) Classification. Class II (perform- that is used to set an instrument in- ance standards). tended to measure mean cell volume [45 FR 60628, Sept. 12, 1980] (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemo- § 864.7900 Thromboplastin generation globin concentration (MCHC), or other test. cell indices. It is a suspension of par- (a) Identification. A thromboplastin ticles or cells whose size, shape, con- generation test is a device used to de- centration, and other characteristics tect and identify coagulation factor de- have been precisely and accurately de- ficiencies and coagulation inhibitors. termined. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). This device is exempt from the ance standards). premarket notification procedures in [45 FR 60631, Sept. 12, 1980] subpart E of part 807 of this chapter subject to the limitations in § 864.9. § 864.8165 Calibrator for hemoglobin or measurement. [45 FR 60628, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, (a) Identification. A calibrator for he- 2001] moglobin or hematocrit measurement is a device that approximates whole § 864.7925 Partial thromboplastin time blood, red blood cells, or a hemoglobin tests. derivative and that is used to set in- (a) Identification. A partial thrombo- struments intended to measure hemo- plastin time test is a device used for globin, the hematocrit, or both. It is a primary screening for coagulation ab- material whose characteristics have

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