# K022018: Rhigene Ana Elisa Test System, Model K7560

- Pathway: 510(k) (Special)
- Applicant: Rhigene, Inc.
- Decided: Jul 5, 2002 after 15 days
- Product code: LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls)
- 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 RhiGene MESACUP ANA TEST is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene MESACW ANA TEST is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

Source page: https://510kreport.com/device/K022018
Methodology: https://510kreport.com/methodology