Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7470](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7470) → NOZ — Assay, 1,5-Anhydroglucitol (15ag)

# NOZ · Assay, 1,5-Anhydroglucitol (15ag)

_Hematology · 21 CFR 864.7470 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NOZ

## Overview

- **Product Code:** NOZ
- **Device Name:** Assay, 1,5-Anhydroglucitol (15ag)
- **Regulation:** [21 CFR 864.7470](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7470)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## 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](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NOZ/K180209.md) | Diazyme 1,5-AG Assay | Diazyme Laboratories, Inc. | Oct 4, 2018 | SESE |
| [K031604](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NOZ/K031604.md) | GLYCOMARK | Tomen America, Inc. | Sep 22, 2003 | SESE |

## Top Applicants

- Diazyme Laboratories, Inc. — 1 clearance
- Tomen America, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NOZ](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NOZ)

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