510(k) · Cleared
ClearedC-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Feb 9, 2006 as substantially equivalent to K042485 (Roche Diagnostics Corp., 2004) and 1 other predicate after a 48-day review. Its family tree reaches back 4 generations to 1989. 2 later devices descend from it.
- Decided
- Feb 9, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- NQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K895880 (1989). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- 3 generations backK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- 2 generations backK003400 CRP HS Test SystemRoche Diagnostics Corp. · 2001
- 1 generation backK042485 Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex)…Roche Diagnostics Corp. · 2004 · Recalled
- This deviceK053603 C-Reactive Protein (Latex) High Sensitive Test System for Cobas…Roche Diagnostics Corp. · 2006
- Descendant · cites it directly · 0 of its ownK260026 Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics · 2026
- Descendant · cites it directly · 0 of its ownK180099 Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| −3 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| −2 | K003400 | CRP HS Test System | Roche Diagnostics Corp. | 2001 | — |
| −1 | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High… | Roche Diagnostics Corp. | 2004 | 1 |
| 0 (this device) | K053603 | C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra… | Roche Diagnostics Corp. | 2006 | — |
| +1 | K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | 2026 | — |
| +1 | K180099 | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2026 | 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 K260026 Tina-quant Cardiac high sensitivity CRP IIIscore 12.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Summary page 1…AS Integra instruments is devices substantially equivalent to the currently marketed Roche Tina-quant® CRP (latex) HS Test System cleared under K042485. For purposes of cardiac risk assessment, the CRP (latex) HS system is also equivalent to the Dade Behring… | 2004 |
| * | K033908 | N High Sensitivity CRPSummary page 1…2485. For purposes of cardiac risk assessment, the CRP (latex) HS system is also equivalent to the Dade Behring N High Sensitivity CRP (K033908) Device The CRP (latex) HS Test System is a latex particle-enhanced Description immunoturbidimetric test for the… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K260026 (Roche Diagnostics, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042485.
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.
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 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…
Read the full statement (109 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053603: C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053603
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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