# K980639: Seraquest Anti-SSB

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Jun 15, 1998 after 116 days
- Product code: LLL (Extractable Antinuclear 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 its predicate without a number.
- (no number) Shield Diastat Anti-SSB test: named in the summary without a submission number

## Indications for use
For in vitro diagnostic use only. For the qualitative and semi-quantitative detection of IgG antibodies to SSB antigen in human serum by enzyme immunoassay. For use as an aid in the diagnosis of systemic rheumatic disease, particularly Sjogren's Syndrome. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Source page: https://510kreport.com/device/K980639
Methodology: https://510kreport.com/methodology