{"data":{"id":"us/21-cfr-864.7470","jurisdiction":"us","citation":"21 CFR 864.7470","heading":"Glycosylated hemoglobin assay.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart H—Hematology Kits and Packages"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"df264bd75dbb65916d2aecab1812270d46ea0673830ee618320e124441975370","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7455","next":"us/21-cfr-864.7490"},"notice":"GroundRules: Original legal text. Not legal advice."}