# K051484: Zeus Scientific, Inc., Athena Multi-Lyte MMRV Igg Test System.

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Dec 5, 2005 after 182 days
- Product code: LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster)
- Device class: 2
- Regulation: 21 CFR 866.3900
- 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® VZV IgG Test System is a microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to Varicella Zoster Virus in human serum using the AtheNA Multi-Lyte® System. The test system is intended to be used for determination of a previous infection with Varicella-Zoster Virus.

Source page: https://510kreport.com/device/K051484
Methodology: https://510kreport.com/methodology