21 CFR 864.7470 — Assay, Glycosylated Hemoglobin

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7470

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
LCPAssay, Glycosylated Hemoglobin2249
NGBTest, Glycosylated Hemoglobin, Over The Counter20
NOZAssay, 1,5-Anhydroglucitol (15ag)22
Innolitics

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