# K033780: Modification to Seraquest Vca Igm

- Pathway: 510(k) (Special)
- Applicant: Quest Intl., Inc.
- Decided: Jan 15, 2004 after 42 days
- Product code: LJN (Antibody Igm, If, Epstein-Barr Virus)
- 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 IgM ELISA test: named in the summary without a submission number

## Indications for use
For In Vitro Diagnostic Use For the qualitative detection of human IgM antibodies to Epstein-Barr (EB) viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. A positive result is presumptive for the detection of anti-Epstein-Barr virus IgM antibodies and presumptive for the diagnosis of acute or recent Epstein-Barr virus infection.

Source page: https://510kreport.com/device/K033780
Methodology: https://510kreport.com/methodology