# K980391: Seraquest Anti-Dsdna

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Apr 24, 1998 after 81 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. The FDA summary names its predicate without a number.
- (no number) Shield DIASTAT Anti-dsDNA kit: named in the summary without a submission number

## Indications for use
For in vitro diagnostic use only. For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to dsDNA in human serum by enzyme immunoassay. For use as an aid in the diagnosis of systemic lupus erythematosus (SLE). For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Source page: https://510kreport.com/device/K980391
Methodology: https://510kreport.com/methodology