# K972456: Rheumacol Rheumatoid Factor Test

- Pathway: 510(k) (Traditional)
- Applicant: Immunostics Inc.,
- Decided: Nov 25, 1997 after 147 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
The Rheumacol RF Test is a rapid color enhanced hemaggiutination slide test for the qualitative and quantitative detection of rheumatoid factor (RF) in serum and is to be used as an aid in the diagnosis of rheumatoid arthritis. This test is “For Professional Use Only”.

Source page: https://510kreport.com/device/K972456
Methodology: https://510kreport.com/methodology