# K983924: Hep-2000 Colorzyme Ana-RO Test System, Model 4200-RO

- Pathway: 510(k) (Traditional)
- Applicant: Immuno Concepts, Inc.
- Decided: Dec 18, 1998 after 44 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: 2 generations back to K935129 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955603: Relsia SS-a/RO & SS/B LA Antibody Test System, Immuno Concepts, Inc. (1996) Summary page 1.

## Indications for use
This is an indirect immunoenzyme antibody test for the semi-quantitative detection of antinuclear antibodies in human serum, with specific identification of autoantibodies to the SS-A/Ro antigen. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.

Source page: https://510kreport.com/device/K983924
Methodology: https://510kreport.com/methodology