# K112221: Euroimmun Anti-Sla/LP Elisa (LGG)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun US
- Decided: Sep 11, 2012 after 406 days
- Product code: NIY (Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis)
- 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
Longest line of descent: 1 generation back to K021482 (2002). 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)
- K021482: Quanta Lite Sla (Soluble Liver Antigen) Elisa, Inova Diagnostics, Inc. (2002) Summary page 2.

## Indications for use
The EUROIMMUN Anti-SLAILP ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against SLAILP (soluble liver antigen/liver-pancreas antigen) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 1, in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K112221
Methodology: https://510kreport.com/methodology