FDA product code NOZ: Assay, 1,5-Anhydroglucitol (15ag)
NOZ is the FDA product code for assay, 1,5-anhydroglucitol (15ag). It is a Class II device, regulated under 21 CFR 864.7470 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under NOZ, from 2 different applicants. The average 510(k) review took 188 days (median 188).
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.
Classification
| Field | Value |
|---|---|
| Device name | Assay, 1,5-Anhydroglucitol (15ag) |
| Device class | Class II |
| Regulation | 21 CFR 864.7470 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
510(k) clearances per year for NOZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 253 |
Compare with all 510(k) review times · Search every NOZ clearance
Top NOZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diazyme Laboratories, Inc. | 1 | 2018-10-04 |
| Tomen America, Inc. | 1 | 2003-09-22 |
Most recent NOZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180209 | Diazyme Laboratories, Inc. | Diazyme 1,5-AG Assay | 2018-10-04 | 253 |
| K031604 | Tomen America, Inc. | GLYCOMARK | 2003-09-22 | 123 |
Recalls for NOZ devices
openFDA lists no recalls for product code NOZ.
Frequently asked questions
What is FDA product code NOZ?
NOZ is the FDA product code for assay, 1,5-anhydroglucitol (15ag). It is a Class II device, regulated under 21 CFR 864.7470 and reviewed by the Hematology panel.
What device class is NOZ?
Class II, regulation 21 CFR 864.7470. Typical premarket route: 510(k).
How long does a 510(k) take for product code NOZ?
Across 2 cleared submissions the average was 188 days from receipt to decision (median 188).
Which companies have the most NOZ clearances?
Diazyme Laboratories, Inc. (1); Tomen America, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NOZ
- Run a recall and safety report across every NOZ manufacturer
- Watch product code NOZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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