510(k) · Cleared
ClearedTina-quant Cardiac high sensitivity CRP III
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Apr 2, 2026 as substantially equivalent to K053603 (Roche Diagnostics Corp., 2006) after an 87-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Apr 2, 2026
- Review
- 87 days
- Class
- Class II
- Product code
- NQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K895880 (1989). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- 4 generations backK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- 3 generations backK003400 CRP HS Test SystemRoche Diagnostics Corp. · 2001
- 2 generations backK042485 Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex)…Roche Diagnostics Corp. · 2004 · Recalled
- 1 generation backK053603 C-Reactive Protein (Latex) High Sensitive Test System for Cobas…Roche Diagnostics Corp. · 2006
- This deviceK260026 Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| −4 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| −3 | K003400 | CRP HS Test System | Roche Diagnostics Corp. | 2001 | — |
| −2 | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High… | Roche Diagnostics Corp. | 2004 | 1 |
| −1 | K053603 | C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra… | Roche Diagnostics Corp. | 2006 | — |
| 0 (this device) | K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NQD device
- #1 K212559 CardioPhase® hsCRPscore 7.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053603 | C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsSummary page 5…t system Product Codes, NQD, 866.5270 Regulation Numbers Predicate Devices C-Reactive Protein (Latex) High Sensitive test system (K053603) Roche Diagnostics GmbH Mannheim, Germany: 9610126 Establishment Registration Roche Diagnostics Gm… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K053603.
How does its category compare?
All NQD devicesNQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NQD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQD
59in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQD
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQD
2in 2025
MAUDE reports naming product code NQD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 59 | 0 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 2 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260026: Tina-quant Cardiac high sensitivity CRP III.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260026
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026