# K981496: Color-Slide RF

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: Jun 15, 1998 after 49 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. The FDA summary names its predicate without a number.
- (no number) SeraTest™ RF: named in the summary without a submission number
- (no number) Rapitex RF: named in the summary without a submission number

## Indications for use
The test provides qualitative and semi-quantitative determination of rheumatoid factors (RF) in human serum. The test provides results for one of the seven criteria used in the diagnosis of rheumatoid arthritis as suggested by the American College of Rheumatology

Source page: https://510kreport.com/device/K981496
Methodology: https://510kreport.com/methodology