§ 864.7360 21 CFR Ch. I (4–1–10 Edition)

(b) Classification. Class II (perform- § 864.7415 Abnormal assay. ance standards). (a) Identification. An abnormal hemo- [45 FR 60615, Sept. 12, 1980] assay is a device consisting of the reagents, apparatus, instrumenta- § 864.7360 Erythrocytic glucose-6-phos- tion, and controls necessary to isolate phate dehydrogenase assay. and identify abnormal genetically de- (a) Identification. An erythrocytic termined hemoglobin types. glucose-6-phosphate dehydrogenase (b) Classification. Class II (perform- assay is a device used to measure the ance standards). activity of the enzyme glucose-6-phos- [45 FR 60618, Sept. 12, 1980] phate dehydrogenase or of glucose-6- phosphate dehydrogenase isoenzymes. § 864.7425 assay. The results of this assay are used in (a) Identification. A the diagnosis and treatment of carboxyhemoglobin assay is a device nonspherocytic congenital hemolytic used to determine the anemia or drug-induced hemolytic ane- carboxyhemoglobin (the compound mia associated with a glucose-6-phos- formed when hemoglobin is exposed to phate dehydrogenase deficiency. This carbon monoxide) content of human generic device includes assays based on as an aid in the diagnosis of car- fluorescence, electrophoresis, bon monoxide poisoning. This measure- reduction, catalase in- ment may be made using methods such as spectroscopy, colorimetry, hibition, and ultraviolet kinetics. spectrophotometry, and gasometry. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). [45 FR 60616, Sept. 12, 1980] [45 FR 60619, Sept. 12, 1980]

§ 864.7375 Glutathione reductase § 864.7440 Electrophoretic hemoglobin assay. analysis system. (a) Identification. A glutathione re- (a) Identification. An electrophoretic ductase assay is a device used to deter- hemoglobin analysis system is a device mine the activity of the enzyme gluta- that electrophoretically separates and thione reductase in serum, plasma, or identifies normal and abnormal hemo- erythrocytes by such techniques as flu- globin types as an aid in the diagnosis orescence and photometry. The results of anemia or erythrocytosis (increased of this assay are used in the diagnosis total red cell mass) due to a hemo- of liver disease, glutathione reductase globin abnormality. deficiency, or riboflavin deficiency. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). [45 FR 60620, Sept. 12, 1980]

[45 FR 60616, Sept. 12, 1980] § 864.7455 assay. (a) Identification. A fetal hemoglobin § 864.7400 assay. assay is a device that is used to deter- (a) Identification. A hemoglobin A2 mine the presence and distribution of assay is a device used to determine the fetal hemoglobin (hemoglobin F) in red hemoglobin A2 content of human blood. cells or to measure the amount of fetal The measurement of hemoglobin A2 is hemoglobin present. The assay may be used in the diagnosis of the used to detect fetal red cells in the ma- (hereditary hemolytic ternal circulation or to detect the ele- anemias characterized by decreased vated levels of fetal hemoglobin exhib- synthesis of one or more types of he- ited in cases of hemoglobin abnormali- moglobin polypeptide chains). ties such as (a hereditary (b) Classification. Class II (perform- hemolytic anemia characterized by a ance standards). decreased synthesis of one or more types of hemoglobin polypeptide [45 FR 60617, Sept. 12, 1980] chains). The hemoglobin determination

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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 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 (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- , 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 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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