FDA product code NRI: Autoantibodies, Nuclear Pore Glycoprotein Gp210
NRI is the FDA product code for autoantibodies, nuclear pore glycoprotein gp210. It is a Class II device, regulated under 21 CFR 866.5090 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under NRI. The average 510(k) review took 96 days (median 96).
Definition
The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis.
Classification
| Field | Value |
|---|---|
| Device name | Autoantibodies, Nuclear Pore Glycoprotein Gp210 |
| Device class | Class II |
| Regulation | 21 CFR 866.5090 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top NRI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 2 | 2006-10-18 |
Most recent NRI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061842 | Inova Diagnostics, Inc. | QUANTA LITE PBC SCREEN IGG/IGA ELISA | 2006-10-18 | 111 |
| K040885 | Inova Diagnostics, Inc. | QUANTA LITE GP210 ELISA | 2004-06-25 | 81 |
Recalls for NRI devices
openFDA lists no recalls for product code NRI.
Frequently asked questions
What is FDA product code NRI?
NRI is the FDA product code for autoantibodies, nuclear pore glycoprotein gp210. It is a Class II device, regulated under 21 CFR 866.5090 and reviewed by the Immunology panel.
What device class is NRI?
Class II, regulation 21 CFR 866.5090. Typical premarket route: 510(k).
How long does a 510(k) take for product code NRI?
Across 2 cleared submissions the average was 96 days from receipt to decision (median 96).
Which companies have the most NRI clearances?
Inova Diagnostics, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NRI
- Run a recall and safety report across every NRI manufacturer
- Watch product code NRI 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.