# K160070: Rheumatoid Factor (RF) Kit for use on SPAPLUS

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Dec 7, 2016 after 329 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162263: Optilite Rheumatoid Factor Kit (2017), 0 descendants of its own

## Recalls of this device
- Nov 6, 2019 · Class II · Z-1500-2020: It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which ma
- Jan 4, 2018 · Class II · Z-0553-2018: The low and high controls for the product are returning results above the assigned values.

## Indications for use
The Rheumatoid Factor (RF) Kit for use on SPAPLUS is intended for the quantitative in vitro measurement of rheumatoid factors in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K160070
Methodology: https://510kreport.com/methodology