510(k) DEN140002
DEN140002 is an FDA 510(k) premarket notification submitted by Euroimmun US for the device "EUROIMMUN ANTI-PLA2R IFA". The FDA issued a decision of De Novo Granted on May 29, 2014. The device falls under product code PGV (Anti-Phospholipase A2 Receptor), a Class II device regulated under 21 CFR 866.5780. Euroimmun US has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 29, 2014
- Date Received
- March 28, 2014
- Clearance Type
- Post-NSE
- 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.