864.7470 Glycosylated hemoglobin assay.§ 864.7470 Glycosylated hemoglobin assay.
(a) Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.
(b) Classification. Class II (performance standards).[45 FR 60621, Sept. 12, 1980]