# K063186: Athena Multi-Lyte Rubella Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Mar 21, 2007 after 152 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- 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 Rubella IgG Test System is intended for the qualitative detection of IgG class antibody to Rubella virus in human sera by microparticle immunoassay testing on the AtheNA Multi-Lyte instrument. The results of the AtheNA Multi-Lyte Rubella IgG Test System may be used to determine the serological status of individuals including women of childbearing age. This test has been calibrated to the WHO International Standard for Rubella IgG at the cut-off. The magnitude of the test result above or below the cut-off does not correspond to International Units and is not indicative of total amount of antibody present.

Source page: https://510kreport.com/device/K063186
Methodology: https://510kreport.com/methodology