# Assay, 1,5-Anhydroglucitol (15ag)
> **Product code: NOZ** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7470
## Classification
- **FDA Product Code:** NOZ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.7470
- **Review panel:** HE
- **Medical specialty:** Hematology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NOZ)
---
*AI Analytics · CC0 1.0*