# K032336: Tina-Quant CRP (Latex)

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 5, 2003 after 7 days
- Product code: DCN (System, Test, C-Reactive Protein)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K895880 (1989). 4 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K003400: CRP HS Test System, Roche Diagnostics Corp. (2001) Summary page 1.

## Most influential descendants
- K083444: C-Reactive Protein (Latex) (2009), 2 descendants of its own
- 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

## Indications for use
Immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on automated clinical chemistry analyzers. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Source page: https://510kreport.com/device/K032336
Methodology: https://510kreport.com/methodology