§ 864.7360 21 CFR Ch. I (4–1–10 Edition)
(b) Classification. Class II (perform- § 864.7415 Abnormal hemoglobin assay. ance standards). (a) Identification. An abnormal hemo- [45 FR 60615, Sept. 12, 1980] globin 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 Carboxyhemoglobin 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 blood as an aid in the diagnosis of car- fluorescence, electrophoresis, bon monoxide poisoning. This measure- methemoglobin 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 Fetal hemoglobin assay. (a) Identification. A fetal hemoglobin § 864.7400 Hemoglobin A2 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- thalassemias (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 thalassemia (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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