# K113439: Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun US
- Decided: Apr 12, 2013 after 508 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 K000535 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052262: Quanta Lite M2 EP (MIT3) Elisa, Inova Diagnostics, Inc. (2005) Summary page 2.
- K050662: Quanta Lite SP100 Elisa, Inova Diagnostics, Inc. (2005) Summary page 2.
- K040885: Quanta Lite GP210 Elisa, Inova Diagnostics, Inc. (2004) Summary page 2.
- K000535: Quanta Lite LKM-1 Elisa, Inova Diagnostics, Inc. (2000) Summary page 2.
- K021482: Quanta Lite Sla (Soluble Liver Antigen) Elisa, Inova Diagnostics, Inc. (2002) Summary page 2.

## Indications for use
The EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgO) Kit is an immune line-blot strip test intended for the qualitative detection of LgG class antibodies against 8 different antigens: AMA-M2, M2-3E (BPO), SplOO, PML, gp2lO, LKM-1, LC-1 and SLAILP in human serum and plasma (EDTA, Li-heparin, Citrate). Detection of these antibodies is used as an aid in the diagnosis of autoimmune liver diseases in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K113439
Methodology: https://510kreport.com/methodology