Food and Drug Administration, HHS § 864.7695

§ 864.7490 Sulfhemoglobin assay. cytochemical identification of alkaline phosphatase depends on the formation (a) Identification. A sulfhemoglobin 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 (b) Classification. Class II (perform- subpart E of part 807 of this chapter ance standards). subject to the limitations in § 864.9. [45 FR 60621, Sept. 12, 1980] [45 FR 60623, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, § 864.7500 Whole blood hemoglobin as- 2001] says. (a) Identification. A whole blood he- § 864.7675 Leukocyte peroxidase test. moglobin assay is a device consisting (a) Identification. A leukocyte peroxi- or reagents, calibrators, controls, or dase test is a device used to distinguish photometric or spectrophotometric in- certain myeloid cells derived from the strumentation used to measure the he- bone marrow, i.e., neutrophils, moglobin content of whole blood for eosinophils, and monocytes, from the detection of anemia. This generic lymphoid cells of the lymphatic system device category does not include auto- and erythroid cells of the red blood cell mated hemoglobin systems. series on the basis of their peroxidase (b) Classification. Class II (perform- activity as evidenced by staining. The ance standards). results of this test are used in the dif- ferential diagnosis of the leukemias. [45 FR 60622, Sept. 12, 1980] (b) Classification. Class I (general con- § 864.7525 Heparin assay. trols). This device is exempt from the 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- tient’s circulation. These assays are [45 FR 60624, Sept. 12, 1980, as amended at 59 quantitative clotting time procedures FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, using the effect of heparin on activated 2001] coagulation factor X (Stuart factor) or procedures based on the neutralization § 864.7695 Platelet factor 4 of heparin by protamine sulfate (a pro- radioimmunoassay. tein that neutralizes heparin). (a) Identification. A platelet factor 4 (b) Classification. Class II (perform- radioimmunoassay is a device used to ance standards). measure the level of platelet factor 4, a protein released during platelet activa- [45 FR 60623, Sept. 12, 1980] tion by radioimmunoassay. This device § 864.7660 Leukocyte alkaline phos- measures platelet activiation, which phatase test. may indicate a coagulation disorder, such as myocardial infarction or coro- (a) Identification. A leukocyte alka- nary artery disease. line phosphatase test is a device used to identify the enzyme leukocyte alka- (b) Classification. Class II (perform- line phosphatase in neutrophilic ance standards). granulocytes (granular leukocytes [45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. stainable by neutral dyes). The 3, 1981]

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