# K033915: Modification to Seraquest EB Vca Igg

- Pathway: 510(k) (Special)
- Applicant: Quest Intl., Inc.
- Decided: Jan 16, 2004 after 29 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) Zeus EBV VCA IgG Test System: named in the summary without a submission number

## Indications for use
1. For In Vitro Diagnostic Use 2. For the qualitative and semi-quantitative detection of human IgG antibodies to Epstein-Barr (EB) viral capsid antigen (VCA) in human serum by enzyme immunoassay. 3. For use as an aid in differentiating active or recent infection, from past infection.

Source page: https://510kreport.com/device/K033915
Methodology: https://510kreport.com/methodology