# K053603: C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Feb 9, 2006 after 48 days
- Product code: NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control)
- 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: 4 generations back to K895880 (1989). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042485: Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive), Roche Diagnostics Corp. (2004) Summary page 1.
- K033908: N High Sensitivity CRP, Dade Behring, Inc. (2004) Summary page 1.

## Most influential descendants
- K260026: Tina-quant Cardiac high sensitivity CRP III (2026), 0 descendants of its own
- K180099: Optilite High Sensitivity C-Reactive Protein Kit (2018), 0 descendants of its own

## Indications for use
The CRP (Latex) High Sensitive Immunoturbidimetric 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/K053603
Methodology: https://510kreport.com/methodology