# K980811: Seraquest Anti-SM/RNP

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: May 12, 1998 after 70 days
- Product code: LKP (Anti-Sm 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-Sm/RNP: 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 Sm/RNP in human serum by enzyme immunoassay. For use as an aid in the diagnosis of systemic rheumatic disease, particularly mixed connective tissue disease (MCTD). For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Source page: https://510kreport.com/device/K980811
Methodology: https://510kreport.com/methodology