# K972145: Hep-2000 Fluorescent Ana-RO Test System

- Pathway: 510(k) (Traditional)
- Applicant: Immuno Concepts, Inc.
- Decided: Feb 24, 1998 after 263 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.
2 later devices descend from it; 2 cite it directly.
0 of 5 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.

## Most influential descendants
- K131791: Ifa 40: Hep-20-10 (2014), 0 descendants of its own
- K060431: Anti Rna Polymerase Iii Elisa Kit, Model 7805 (2006), 0 descendants of its own

## Indications for use
This is an indirect fluorescent 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 system rheumatic disease.

Source page: https://510kreport.com/device/K972145
Methodology: https://510kreport.com/methodology