510(k) K132195
K132195 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN ANTI-PLA2R ELISA (IGG)". The FDA issued a decision of Substantially Equivalent on June 27, 2014. The device falls under product code PGV (Anti-Phospholipase A2 Receptor), a Class II device regulated under 21 CFR 866.5780. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2014
- Date Received
- July 15, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Phospholipase A2 Receptor
- Device Class
- Class II
- Regulation Number
- 866.5780
- Review Panel
- IM
- Submission Type
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.