# K021394: Diamedix IS-Rheumatoid Factor Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Jul 9, 2002 after 68 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. The FDA summary names its predicate without a number.
- (no number) Is-RF Test System: named in the summary without a submission number

## Indications for use
For the quantitative detection of RF IgM-class antibodies in human serum by indirect enzyme immunoassay as an aid in the diagnosis of rheumatoid arthritis (RA). This test kit can be used either manually or in conjunction with the MAGO Plus Automated EIA Processor.

Source page: https://510kreport.com/device/K021394
Methodology: https://510kreport.com/methodology