# K083444: C-Reactive Protein (Latex)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 18, 2009 after 117 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: 4 generations back to K895880 (1989). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032336: Tina-Quant CRP (Latex), Roche Diagnostics Corp. (2003) Summary page 1.

## Most influential descendants
- K192072: Tina-quant C-Reactive Protein IV (2020), 0 descendants of its own
- K161982: C-Reactive Protein Kit for use on SPAPLUS (2017), 0 descendants of its own

## Recalls of this device
- Nov 6, 2020 · Class II · Z-0634-2021: Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color)

## Indications for use
Measurement of c-reactive protein aids in the evaluation of the amount of injury to body tissues.

Source page: https://510kreport.com/device/K083444
Methodology: https://510kreport.com/methodology