# K161982: C-Reactive Protein Kit for use on SPAPLUS

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group
- Decided: Apr 5, 2017 after 260 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
Longest line of descent: 5 generations back to K895880 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083444: C-Reactive Protein (Latex), Roche Diagnostics Corp. (2009) Summary page 5.

## Recalls of this device
- Apr 25, 2019 · Class II · Z-1619-2020: A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected

## Indications for use
The C-Reactive Protein Kit for use on SPAPLUS is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This product is suitable for use on the SPAPLUS analyser.

Source page: https://510kreport.com/device/K161982
Methodology: https://510kreport.com/methodology