# K172868: Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Feb 28, 2018 after 161 days
- Product code: DCN (System, Test, C-Reactive Protein)
- Device class: 2
- Regulation: 21 CFR 866.5270
- 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 19, 2019 · Class II · Z-0671-2020: Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits

Source page: https://510kreport.com/device/K172868
Methodology: https://510kreport.com/methodology