# K024067: Rheumatoid Factor (RF)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 15, 2003 after 36 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 K002609 (2000). 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)
- K002609: Tina-Quant Rheumatoid Factors II Test System, Roche Diagnostics Corp. (2000) Summary page 2.

## Indications for use
The Rheumatoid Factor assay is used for the quantitation of rheumatoid factor in human serum. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Source page: https://510kreport.com/device/K024067
Methodology: https://510kreport.com/methodology