# K974370: Rapet RF

- Pathway: 510(k) (Traditional)
- Applicant: Stanbio Laboratory
- Decided: Feb 17, 1998 after 89 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Feb 13, 2018 · Class II · Z-1070-2018: All patient serum samples yield a weakly positive test result.

## Indications for use
RaPET RF (Class II) is intended for the qualitative and semi-quantitative detection of rheumatoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

Source page: https://510kreport.com/device/K974370
Methodology: https://510kreport.com/methodology