# K970373: Raichem Rheumatoid Factor Spia

- Pathway: 510(k) (Traditional)
- Applicant: Henage Diagnostics, Inc.
- Decided: Apr 17, 1997 after 73 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
Longest line of descent: 1 generation back to K855221 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K855221: Seratest RF (Hemagglutination) Kit, Hemagen Diagnostics, Inc. (1986) Summary page 1.

## Indications for use
A latex agglutination assay intended for the quantitative turbidimetric detection of Rheumatoid IgM antibodies in human serum and plasma. When used according to instructions, the assay is useful in establishing the presence of rheumatoid factor and as an aid in the diagnosis and management of rheumatoid arthritis.

Source page: https://510kreport.com/device/K970373
Methodology: https://510kreport.com/methodology