# K091969: Euroimmun Anti-Desmoglein 1 Elisa (Igg), Euroimmun Anti-Desmoglein 3 Elisa (Igg)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: Sep 2, 2010 after 428 days
- Product code: NBO (Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3))
- 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. The FDA summary names no predicate by number.

## Indications for use
The EUROIMMUN Anti-Desmoglein 1 ELISA (lgG) test kit is intended for the qualitative or semi-quantitative determination of igG class autoantibodies against desmoglein 1 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus~foliaceus (PF), in conjunction with other laboratory and clinical findings. The EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against dlesmoglein 3 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus vulgaris (PV), in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K091969
Methodology: https://510kreport.com/methodology