# K083615: Euroimmun Anti BP 180-4X Elisa (Igg)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: Mar 16, 2009 after 98 days
- Product code: OEG (Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EUROIMMUN Anti-BP 180-4X ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against BP 180 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid (PB), in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K083615
Methodology: https://510kreport.com/methodology