# K042118: Athena Multi-Lyte Ebv Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Apr 29, 2005 after 266 days
- Product code: JRY (Antiserum, Fluorescent, 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Zeus Scientific, Inc. AtheNA Multi-Lyte EBV IgG Test System is intended for the qualitative detection of lgG class antibody to three separate EBV Antigens (EBV-VCA gg-1 125, EBV-EA 'total' and recombinant EBNA-1) in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used with these EBV IgG markers along with anti-EBV VCA IgM to aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and to provide epidemiological information on the diseases caused by EBV virus.

Source page: https://510kreport.com/device/K042118
Methodology: https://510kreport.com/methodology