# K993843: Mdi RF Test

- Pathway: 510(k) (Traditional)
- Applicant: Micro Detect, Inc.
- Decided: Jan 11, 2000 after 60 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 no predicate by number.

## Indications for use
The MDI RF Test is a semi quantitative Enzyme Immunoassay (EIA) Kit for the detection of IgM antibodies against human IgG (RF) in human serum. The test is intended as an aid in the diagnosis of rheumatoid arthritis. FOR IN VITRO DIAGNOSTIC USE ONLY.

Source page: https://510kreport.com/device/K993843
Methodology: https://510kreport.com/methodology