# K083381: Euroimmun Anti-Dsdna-NCX Elisa (Igg)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: Apr 15, 2009 after 152 days
- Product code: LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or qualitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and EDTA or citrate plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K083381
Methodology: https://510kreport.com/methodology