FDA product code NWG: Autoantibodies, Glutamic Acid Decarboxylase (Gad)
NWG is the FDA product code for autoantibodies, glutamic acid decarboxylase (gad). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under NWG. The average 510(k) review took 144 days (median 144).
Definition
The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).
Classification
| Field | Value |
|---|---|
| Device name | Autoantibodies, Glutamic Acid Decarboxylase (Gad) |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NWG clearance
Top NWG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kronus Market Development Associates, Inc. | 2 | 2007-11-07 |
Most recent NWG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072135 | Kronus Market Development Associates, Inc. | KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT | 2007-11-07 | 97 |
| K051061 | Kronus Market Development Associates, Inc. | KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT | 2005-11-04 | 192 |
Recalls for NWG devices
openFDA lists no recalls for product code NWG.
Frequently asked questions
What is FDA product code NWG?
NWG is the FDA product code for autoantibodies, glutamic acid decarboxylase (gad). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is NWG?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code NWG?
Across 2 cleared submissions the average was 144 days from receipt to decision (median 144).
Which companies have the most NWG clearances?
Kronus Market Development Associates, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NWG
- Run a recall and safety report across every NWG manufacturer
- Watch product code NWG 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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