# K041891: Minineph Human Rheumatoid Factor Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site
- Decided: Nov 5, 2004 after 116 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This kit is designed for the In Vitro measurement of human Rheumatoid Factor in serum, using the MININEPH. Measurement of Rheumatoid Factor may aid in the diagnosis of rheumatoid arthritis.

Source page: https://510kreport.com/device/K041891
Methodology: https://510kreport.com/methodology