Code of Federal Regulations Title 21. Food and Drugs § 21.864.7360 Erythrocytic glucose–6–phosphate dehydrogenase assay

(a) Identification. An erythrocytic glucose–6–phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose–6–phosphate dehydrogenase or of glucose–6–phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose–6–phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.

(b) Classification. Class II (performance standards).