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 phos- phatase 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 alka- line 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 as- says. § 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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