Glycosylated hemoglobin assay.

(a) Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A 1a , A 1b , and A 1c ) 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]