# K042680: Rhigene Hep-Ana Test System

- Pathway: 510(k) (Traditional)
- Applicant: Corgenix, Inc.
- Decided: Nov 19, 2004 after 51 days
- Product code: DHN (Antinuclear Antibody, Indirect Immunofluorescent, 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
Longest line of descent: 1 generation back to K872845 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872845: Bion Antinuclear Antibody (Ana)Test Kit/Contr Serum, Bion Ent., Ltd. (1987) Summary page 1.

## Indications for use
The HEP-ANA Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies in human serum. The HEP-ANA Test System is intended for use as an aid in the diagnosis of certain autoimmune diseases. The HEP-ANA Test System is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K042680
Methodology: https://510kreport.com/methodology