FDA product code NUM: Autoantibodies, Nuclear Body Protein, Sp100
NUM is the FDA product code for autoantibodies, nuclear body protein, sp100. It is a Class II device, regulated under 21 CFR 866.5090 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under NUM. The average 510(k) review took 90 days (median 90).
Definition
THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.
Classification
| Field | Value |
|---|---|
| Device name | Autoantibodies, Nuclear Body Protein, Sp100 |
| 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 |
Compare with all 510(k) review times · Search every NUM clearance
Top NUM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 1 | 2005-06-13 |
Most recent NUM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050662 | Inova Diagnostics, Inc. | QUANTA LITE SP100 ELISA | 2005-06-13 | 90 |
Recalls for NUM devices
openFDA lists no recalls for product code NUM.
Frequently asked questions
What is FDA product code NUM?
NUM is the FDA product code for autoantibodies, nuclear body protein, sp100. It is a Class II device, regulated under 21 CFR 866.5090 and reviewed by the Immunology panel.
What device class is NUM?
Class II, regulation 21 CFR 866.5090. Typical premarket route: 510(k).
How long does a 510(k) take for product code NUM?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most NUM clearances?
Inova Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NUM
- Run a recall and safety report across every NUM manufacturer
- Watch product code NUM 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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