# K131185: Ana Screen Elisa (Igg)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun US
- Decided: Jul 15, 2013 after 80 days
- Product code: LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls)
- 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 ANA Screen ELISA (lgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of dsDNA, histones, ribosomal P-proteins, rRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-i and centromeres) in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of mixed connective tissue diseases (MCTD), systemic lupus erythematosus, Sjbgren's syndrome, progressive systemic sclerosis and poly-/dermatomyositis, in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K131185
Methodology: https://510kreport.com/methodology