NOZ · Assay, 1,5-Anhydroglucitol (15ag)
Hematology · 21 CFR 864.7470 · Class 2
Overview
| Product Code | NOZ |
|---|---|
| Device Name | Assay, 1,5-Anhydroglucitol (15ag) |
| Regulation | 21 CFR 864.7470 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K180209 | Diazyme 1,5-AG Assay | Diazyme Laboratories, Inc. | Oct 4, 2018 | SESE |
| K031604 | GLYCOMARK | Tomen America, Inc. | Sep 22, 2003 | SESE |
Top Applicants
- Diazyme Laboratories, Inc. — 1 clearance
- Tomen America, Inc. — 1 clearance
