FDA product code PGV: Anti-Phospholipase A2 Receptor
PGV is the FDA product code for anti-phospholipase a2 receptor. It is a Class II device, regulated under 21 CFR 866.5780 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under PGV. The average 510(k) review took 347 days (median 347). 1 De Novo request was granted under it.
Definition
The test system is intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Phospholipase A2 Receptor |
| Device class | Class II |
| Regulation | 21 CFR 866.5780 |
| Review panel | IM — Immunology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PGV clearance
Top PGV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Euroimmun Us, Inc. | 1 | 2014-06-27 |
Most recent PGV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132195 | Euroimmun Us, Inc. | EUROIMMUN ANTI-PLA2R ELISA (IGG) | 2014-06-27 | 347 |
Recalls for PGV devices
openFDA lists no recalls for product code PGV.
Frequently asked questions
What is FDA product code PGV?
PGV is the FDA product code for anti-phospholipase a2 receptor. It is a Class II device, regulated under 21 CFR 866.5780 and reviewed by the Immunology panel.
What device class is PGV?
Class II, regulation 21 CFR 866.5780. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGV?
Across 1 cleared submissions the average was 347 days from receipt to decision (median 347).
Which companies have the most PGV clearances?
Euroimmun Us, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PGV
- Run a recall and safety report across every PGV manufacturer
- Watch product code PGV 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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