# K143736: ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Sep 23, 2015 after 267 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- 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
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.

Source page: https://510kreport.com/device/K143736
Methodology: https://510kreport.com/methodology