# K991459: Copalis Ebv-M Antibody Assay

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: May 14, 1999 after 18 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) Gull Laboratories EBV IgM IFA: named in the summary without a submission number

## Indications for use
The Copalis® EBV-M Assay uses Coupled Particle Light Scattering technology in a microparticle agglutination-based assay for the qualitative detection of IgM antibodies to the EBV VCA antigen. The assay is designed for human serum using the Copalis® I Immunoassay System. The presence of VCA IgM antibodies is used as an aid in the diagnosis of EBV associated mononucleosis when used in conjunction with other EBV serologies in pediatric, adult, transplant donor and transplant recipient populations.

Source page: https://510kreport.com/device/K991459
Methodology: https://510kreport.com/methodology