# K990410: Seraquest EB Vca Igg

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Oct 28, 1999 after 261 days
- Product code: LSE (Epstein-Barr Virus, Other)
- Device class: 1
- Regulation: 21 CFR 866.3235
- 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) Gull Laboratories' EBV IgG ELISA 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 Epstein-Barr viral capsid antigen (VCA) in human serum by enzyme immunoassay. For usa.as an aid in differentiating active or recent infection, from past infection. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Source page: https://510kreport.com/device/K990410
Methodology: https://510kreport.com/methodology