# K101319: Immulisa Dsdna Antibody Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Dec 9, 2010 after 212 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
An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to double stranded DNA (dsDNA) in human serum, as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K101319
Methodology: https://510kreport.com/methodology