K132195 is an FDA 510(k) clearance for the EUROIMMUN ANTI-PLA2R ELISA (IGG). This device is classified as a Anti-phospholipase A2 Receptor (Class II - Special Controls, product code PGV).
Submitted by Euroimmun Us, Inc. (Morris Plains, US). The FDA issued a Cleared decision on June 27, 2014, 347 days after receiving the submission on July 15, 2013.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5780. 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..
| 510(k) Number | K132195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2013 |
| Decision Date | June 27, 2014 |
| Days to Decision | 347 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | PGV - Anti-phospholipase A2 Receptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5780 |
| 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. |