FDA product code NPH: Antigen, Cartilage Oligomeric Matrix Protein (Comp)
NPH is the FDA product code for antigen, cartilage oligomeric matrix protein (comp). It is a Class II device, regulated under 21 CFR 866.5775 and reviewed by the Immunology panel. Devices under NPH reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
COMP ELISA is a quantitative enzyme-linked immunosorbent assay for detecting COMP (Cartilage Oligomeric Matrix Protein) in patient sera. The presence of elevated levels, when considered in conjunction with other laboratory and clinical findings, aids in identifying aggressive destruction of joint tissue in Rheumatoid Arthritis.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cartilage Oligomeric Matrix Protein (Comp) |
| Device class | Class II |
| Regulation | 21 CFR 866.5775 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NPH devices
openFDA lists no recalls for product code NPH.
Frequently asked questions
What is FDA product code NPH?
NPH is the FDA product code for antigen, cartilage oligomeric matrix protein (comp). It is a Class II device, regulated under 21 CFR 866.5775 and reviewed by the Immunology panel.
What device class is NPH?
Class II, regulation 21 CFR 866.5775. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NPH
- Run a recall and safety report across every NPH manufacturer
- Watch product code NPH 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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