21 CFR § 864.7470 - Glycosylated hemoglobin assay.

---
identifier: "/us/cfr/t21/s864.7470"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.7470 - Glycosylated hemoglobin assay."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.7470"
section_name: "Glycosylated hemoglobin assay."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 864.7470 Glycosylated hemoglobin assay.

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