FDA product code PET: Anti-Ss-A Ro60 Autoantibodies
PET is the FDA product code for anti-ss-a ro60 autoantibodies. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel. Devices under PET reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Ss-A Ro60 Autoantibodies |
| Device class | Class II |
| Regulation | 21 CFR 866.5100 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for PET devices
openFDA lists no recalls for product code PET.
Frequently asked questions
What is FDA product code PET?
PET is the FDA product code for anti-ss-a ro60 autoantibodies. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel.
What device class is PET?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PET
- Run a recall and safety report across every PET manufacturer
- Watch product code PET 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.