# K990035: RF

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 8, 1999 after 61 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 K964415 (1996). 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)
- K964415: N-Assay Tia Rheumatoid Factor Test Kit, Kamiya Technology Services (1996) Summary page 2.

## Indications for use
The Rheumatoid Factor assay is used for the quantitation of rheumatoid factor (antibodies to immunoglobulins) in human serum or plasma. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Source page: https://510kreport.com/device/K990035
Methodology: https://510kreport.com/methodology