# Anti-Phospholipase A2 Receptor
> **Product code: PGV** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.5780
## Classification
- **FDA Product Code:** PGV
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5780
- **Review panel:** IM
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** Y
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PGV)
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