PGV — Anti-Phospholipase A2 Receptor Class II
FDA product code PGV covers "Anti-Phospholipase A2 Receptor", a Class II medical device regulated under 21 CFR 866.5780. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PGV
- Device Class
- Class II
- Regulation Number
- 866.5780
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Microbiology
- Implant
- No
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.