# K971379: Tinaquant Rheumatoid Factor Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jun 17, 1997 after 64 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 K850296 (1985). 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)
- K850296: Laser RF Test -Rheumatoid Factor (S) Reagents, Behring Diagnostics, Inc. (1985) Summary page 1.

## Indications for use
The Tinaquant Rheumatoid Factor assay is an immunoturbidometric assay for the quantitative determination of rheumatoid factor (antibodies to immunoglobulins) in human serum or plasma using automated clinical chemistry analyzers. Measurement of rheumatoid factor may be used as an aid in the diagnosis of rheumatoid arthritis.

Source page: https://510kreport.com/device/K971379
Methodology: https://510kreport.com/methodology