Leukocyte Peroxidase Test. (A) Identification

Home , Sickle cell trait, Sulfhemoglobinemia

Food and Drug Administration, HHS § 864.7675

may be made by methods such as elec- (b) Classification. Class II (perform- trophoresis, alkali denaturation, col- ance standards). umn chromatography, or radial [45 FR 60622, Sept. 12, 1980] immunodiffusion. (b) Classification. Class II (perform- § 864.7525 Heparin assay. ance standards). (a) Identification. A heparin assay is a [45 FR 60620, Sept. 12, 1980] device used to determine the level of the anticoagulant heparin in the pa- § 864.7470 Glycosylated hemoglobin tient’s circulation. These assays are assay. quantitative clotting time procedures using the effect of heparin on activated (a) Identification. A glycosylated he- coagulation factor X (Stuart factor) or moglobin assay is a device used to procedures based on the neutralization measure the glycosylated hemoglobins of heparin by protamine sulfate (a pro- (A , A , and A ) in a patient’s blood 1a 1b 1c tein that neutralizes heparin). by a column chromatographic proce- (b) Classification. Class II (perform- dure. Measurement of glycosylated he- ance standards). moglobin is used to assess the level of control of a patient’s diabetes and to [45 FR 60623, Sept. 12, 1980] determine the proper insulin dosage for a patient. Elevated levels of § 864.7660 Leukocyte alkaline phosphatase test. glycosylated hemoglobin indicate un- controlled diabetes in a patient. (a) Identification. A leukocyte alka- (b) Classification. Class II (perform- line phosphatase test is a device used ance standards). to identify the enzyme leukocyte alkaline phosphatase in neutrophilic [45 FR 60621, Sept. 12, 1980] granulocytes (granular leukocytes stainable by neutral dyes). The § 864.7490 Sulfhemoglobin assay. cytochemical identification of alkaline (a) Identification. A sulfhemoglobin phosphatase depends on the formation assay is a device consisting of the re- of blue granules in cells containing al- agents, calibrators, controls, and in- kaline phosphatase. The results of this strumentation used to determine the test are used to differentiate chronic sulfhemoglobin (a compound of sulfur granulocytic leukemia (a malignant and hemoglobin) content of human disease characterized by excessive blood as an aid in the diagnosis of overgrowth of granulocytes in the bone sulfhemoglobinemia (presence of marrow) and reactions that resemble sulfhemoglobin in the blood due to true leukemia, such as those occuring drug administration or exposure to a in severe infections and polycythemia poison). This measurement may be (increased total red cell mass). made using methods such as spectros- (b) Classification. Class I (general con- copy, colorimetry, spectrophotometry, trols). This device is exempt from the or gasometry. premarket notification procedures in subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 864.9. ance standards). [45 FR 60623, Sept. 12, 1980, as amended at 59 [45 FR 60621, Sept. 12, 1980] FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, 2001] § 864.7500 Whole blood hemoglobin assays. § 864.7675 Leukocyte peroxidase test. (a) Identification. A whole blood he- (a) Identification. A leukocyte peroxi- moglobin assay is a device consisting dase test is a device used to distinguish or reagents, calibrators, controls, or certain myeloid cells derived from the photometric or spectrophotometric in- bone marrow, i.e., neutrophils, strumentation used to measure the he- eosinophils, and monocytes, from moglobin content of whole blood for lymphoid cells of the lymphatic system the detection of anemia. This generic and erythroid cells of the red blood cell device category does not include auto- series on the basis of their peroxidase mated hemoglobin systems. activity as evidenced by staining. The

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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- [45 FR 60626, Sept. 12, 1980] trols). This device is exempt from the premarket notification procedures in § 864.7750 Prothrombin time test. subpart E of part 807 of this chapter subject to the limitations in § 864.9. (a) Identification. A prothrombin time test is a device used as a general [45 FR 60624, Sept. 12, 1980, as amended at 59 screening procedure for the detection FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, of possible clotting factor deficiencies 2001] in the extrinsic coagulation pathway, which involves the reaction between § 864.7695 Platelet factor 4 coagulation factors III and VII, and to radioimmunoassay. monitor patients receiving coumarin (a) Identification. A platelet factor 4 therapy (the administration of one of radioimmunoassay is a device used to the coumarin anticoagulants in the measure the level of platelet factor 4, a treatment of venous thrombosis or pul- protein released during platelet activa- monary embolism). tion by radioimmunoassay. This device (b) Classification. Class II (perform- measures platelet activiation, which ance standards). may indicate a coagulation disorder, such as myocardial infarction or coro- [45 FR 60626, Sept. 12, 1980] nary artery disease. § 864.7825 Sickle cell test. (b) Classification. Class II (perform- ance standards). (a) Identification. A sickle cell test is a device used to determine the sickle [45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. cell hemoglobin content of human 3, 1981] blood to detect sickle cell trait or sickle cell diseases. § 864.7720 Prothrombin consumption test. (b) Classification. Class II (perform- ance standards). (a) Identification. A prothrombin consumption tests is a device that meas- [45 FR 60627, Sept. 12, 1980] ures the patient’s capacity to generate thromboplastin in the coagulation § 864.7875 Thrombin time test. process. The test also is an indirect in- (a) Identification. A thrombin time dicator of qualitative or quantitative test is a device used to measure platelet abnormalities. It is a screen- fibrinogen concentration and detect ing test for thrombocytopenia (de- fibrin or fibrinogen split products for creased number of blood platelets) and the evaluation of bleeding disorders. hemophilia A and B. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). [45 FR 60628, Sept. 12, 1980] [45 FR 60625, Sept. 12, 1980] § 864.7900 Thromboplastin generation § 864.7735 Prothrombin-proconvertin test. test and thrombotest. (a) Identification. A thromboplastin (a) Identification. The prothrombin- generation test is a device used to de- proconvertin test and thrombotest are tect and identify coagulation factor de- devices used in the regulation of cou- ficiencies and coagulation inhibitors. marin therapy (administration of a (b) Classification. Class I (general con- coumarin anticoagulant such as so- trols). This device is exempt from the dium warfarin in the treatment of ve- premarket notification procedures in nous thrombosis and pulmonary embo- subpart E of part 807 of this chapter lism) and as a diagnostic test in con- subject to the limitations in § 864.9. junction with, or in place of, the Quick [45 FR 60628, Sept. 12, 1980, as amended at 59 prothrombin time test to detect coagu- FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, lation disorders. 2001]

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