# K112223: Euroimmun Anti-LKM-1 Elisa (LGG)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun US
- Decided: Sep 11, 2012 after 406 days
- Product code: NBS (Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1))
- 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 K000535 (2000). 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)
- K000535: Quanta Lite LKM-1 Elisa, Inova Diagnostics, Inc. (2000) Summary page 2.

## Indications for use
The EUROIMMUN Anti-LKM-1 ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against LKM-1 (cytochrome P450 1106 of liver-kidney-microsomes) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 2, in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K112223
Methodology: https://510kreport.com/methodology