# K982281: Seraquest Rubella Igm

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Oct 16, 1998 after 108 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- 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) Diamedix Rubella IgM kit: named in the summary without a submission number

## Indications for use
1. For the qualitative detection of IgM antibodies to Rubella in human serum by enzyme immunoassay, to aid in the diagnosis of Rubella infection. 2. A positive result is presumptive for the detection of anti-rubella antibodies and presumptive for the diagnosis of acute or recent rubella infection. 3. Useful for the above indications, with specimens obtained from women of childbearing age. 4. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Source page: https://510kreport.com/device/K982281
Methodology: https://510kreport.com/methodology