# K991660: Copalis Multiplex Ebv Antibody Assay

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Jun 4, 1999 after 21 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 IFA: named in the summary without a submission number
- (no number) Gull Laboratories EBV-NA IFA: named in the summary without a submission number
- (no number) Gull Laboratories EBV-EA IFA: named in the summary without a submission number

## Indications for use
The Copalis® Multiplex EBV Antibody Assay uses Coupled Particle Light Scattering technology in a microparticle agglutination-based assay for the qualitative or semi-quantitative detection of antibodies to EBV VCA (total antibodies), EBNA (IgG), and EA (IgG and IgM) antigens. The assay is designed for human serum using the Copalis® Immunoassay System. The presence of VCA, EBNA and EA 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. The disease state distinction is made based on the antibody pattern of reactivity. When evaluating properly paired sera, the results of these assays are used to demonstrate seroconversion or significant change in antibody titer as evidence of recent infection. Both specimens should be tested simultaneously.

Source page: https://510kreport.com/device/K991660
Methodology: https://510kreport.com/methodology