# K162263: Optilite Rheumatoid Factor Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: May 3, 2017 after 265 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
Longest line of descent: 1 generation back to K160070 (2016). 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)
- K160070: Rheumatoid Factor (RF) Kit for use on SPAPLUS, The Binding Site Group, Ltd. (2016). Cleared while this submission was under review Summary page 5.

## Recalls of this device
- Oct 7, 2019 · Class II · Z-2110-2020: Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference materi

## Indications for use
The Optilite Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site Optilite 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/K162263
Methodology: https://510kreport.com/methodology