# K132195: Euroimmun Anti-PLA2R Elisa (Igg)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: Jun 27, 2014 after 347 days
- Product code: PGV (Anti-Phospholipase A2 Receptor)
- Device class: 2
- Regulation: 21 CFR 866.5780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN140002 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140002: Euroimmun Anti-PLA2R Ifa, Euroimmun US (2014). Our reading of the summary gave K132379, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN140002, Euroimmun Anti-PLA2R Ifa (Euroimmun US), granted May 29, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
The EUROIMMUN Anti-PLA2R ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R1) in human serum. It is used as an aid in the diagnosis of primary memnbranous giomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K132195
Methodology: https://510kreport.com/methodology