# K042485: Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 29, 2004 after 46 days
- Product code: NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control)
- 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: 3 generations back to K895880 (1989). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 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.
- K033908: N High Sensitivity CRP, Dade Behring, Inc. (2004) Summary page 1.

## Most influential descendants
- K103557: Diazyme HS CRP Assay Kit / Calibrator Set / Control Set (2011), 3 descendants of its own
- K053603: C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments (2006), 2 descendants of its own
- K160712: VITROS Chemistry Products hsCRP Reagent (2017), 1 descendant of its own
- K260026: Tina-quant Cardiac high sensitivity CRP III (2026), 0 descendants of its own
- K191993: Yumizen C1200 CRP (2019), 0 descendants of its own

## Recalls of this device
- Feb 26, 2016 · Class II · Z-1092-2017: Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/L on the MODULAR 

## Indications for use
The Tina-quant® CRP (Latex) High Sensitive Immnmunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.

Source page: https://510kreport.com/device/K042485
Methodology: https://510kreport.com/methodology