# K994071: Rhigene Ana Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Rhigene, Inc.
- Decided: Jan 18, 2000 after 47 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 ANA ELISA TEST SYSTEM is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene ANA ELISA TEST SYSTEM is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases. The RhiGene ANA ELISA TEST SYSTEM uses a mixture of recombinant purified proteins of Jo-1, RNP, SS-A, SS-B, Scl-70, CENP-B and native purified proteins of SS-A, Sm, dsDNA and ssDNA for the solid phase antigen. Therefore, the test shows increased specificity for detection of disease-specific connective tissue diseases such as SLE, Progressive Systemic Sclerosis, Mixed Connective Tissue Diseases, Sjogren’s Syndrome, and Polymyositis.

Source page: https://510kreport.com/device/K994071
Methodology: https://510kreport.com/methodology