# K081251: Modification to Aeskulisa DS Dna G

- Pathway: 510(k) (Special)
- Applicant: Aesku Diagnostics
- Decided: May 13, 2008 after 11 days
- Product code: LSW (Anti-Dna 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
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. The FDA summary names no predicate by number.

## Indications for use
AESKULISA)dsDNA-G is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.

Source page: https://510kreport.com/device/K081251
Methodology: https://510kreport.com/methodology