# K984045: RF Control for Immunoturbidimetric Assays

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Jan 25, 1999 after 73 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 K851202 (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)
- K851202: Gilford Tri-Level Assayed Immunology Control, Gilford (1985) Summary page 1.

## Indications for use
As a consistent test sample of known concentration for monitoring the performance of RF immunoturbidimetric assays.

Source page: https://510kreport.com/device/K984045
Methodology: https://510kreport.com/methodology