# K020972: Wako RF-HA (2), RF Calibrator, RF Calibrator Set

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Sep 9, 2002 after 167 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) Wako Autokit RF: named in the summary without a submission number

## Indications for use
The Wako RF HA2 test is an in vitro diagnostic assay for the quantitative determination of rheumatoid factor activity in serum.

Source page: https://510kreport.com/device/K020972
Methodology: https://510kreport.com/methodology