# K260026: Tina-quant Cardiac high sensitivity CRP III

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 2, 2026 after 87 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: 5 generations back to K895880 (1989). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053603: C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments, Roche Diagnostics Corp. (2006) Summary page 5.

## Indications for use
The Tina-quant Cardiac high sensitivity CRP III application is an in vitro test for the quantitative determination of C reactive protein (CRP) in human serum and plasma on cobas c systems. Cardiac high sensitive measurement of CRP may be used as an aid in the assessment of the risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation methods of acute coronary syndromes, it may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.

Source page: https://510kreport.com/device/K260026
Methodology: https://510kreport.com/methodology