# K112996: Euroimmun Anti-Ena Pool Elisa (Igg)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun US
- Decided: Apr 9, 2013 after 550 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- 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 K081104 (2008). 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)
- K081104: Aeskulisa Ana Hep-2, Ref 30-7115US, Aesku Diagnostics (2008) Summary page 2.

## Indications for use
The EUROIMMUN Anti-ENA Pool ELISA (lgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of nRNAISm, Sm, SS-A (SS-A 60/Ro-52), 55-B, Scl-70, and ribosomal P proteins) in human serum. It is used as an aid in the diagnosis of mixed connective tissue disease (MCTD), systemic lupus erythematosus, Sj~gren's syndrome and progressive systemic sclerosis, in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K112996
Methodology: https://510kreport.com/methodology