# K021103: Modification to Zeus Scientific's Athena Multi-Lyte Ana Test System

- Pathway: 510(k) (Special)
- Applicant: Zeus Scientific, Inc.
- Decided: Apr 24, 2002 after 19 days
- Product code: LKJ (Antinuclear Antibody, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- 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™ ANA Test System is intended for the semi-quantitative detection of IgG class antibody to 8 separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum and the qualitative detection of IgG class antibody to ANA in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune disorders. This test is for in viro diagnostic use.

Source page: https://510kreport.com/device/K021103
Methodology: https://510kreport.com/methodology