510(k) · Cleared
Recalled · Class II · 2016Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)
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 Oct 29, 2004 as substantially equivalent to K003400 (Roche Diagnostics Corp., 2001) and 1 other predicate after a 46-day review. Its family tree reaches back 3 generations to 1989. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 29, 2004
- Review
- 46 days
- Class
- Class II
- Product code
- NQD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K895880 (1989). 6 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- 2 generations backK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- 1 generation backK003400 CRP HS Test SystemRoche Diagnostics Corp. · 2001
- This deviceK042485 Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex)…Roche Diagnostics Corp. · 2004
- Descendant · cites it directly · 3 of its ownK103557 Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011
- Descendant · cites it directly · 2 of its ownK053603 C-Reactive Protein (Latex) High Sensitive Test System for Cobas…Roche Diagnostics Corp. · 2006
- Descendant · 2 generations on · 1 of its ownK160712 VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics · 2017
- Descendant · 2 generations on · 0 of its ownK260026 Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics · 2026
- Descendant · 3 generations on · 0 of its ownK191993 Yumizen C1200 CRPHoriba Abx Sas · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011 · cites it directly3descendants
- K053603C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsRoche Diagnostics Corp. · 2006 · cites it directly2descendants
- K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics · 2017 · 2 generations on1descendant
- K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics · 2026 · 2 generations on0descendants
- K191993Yumizen C1200 CRPHoriba Abx Sas · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| −2 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| −1 | K003400 | CRP HS Test System | Roche Diagnostics Corp. | 2001 | — |
| 0 (this device) | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High… | Roche Diagnostics Corp. | 2004 | — |
| +1 | K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control Set | Diazyme Laboratories | 2011 | — |
| +1 | K053603 | C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra… | Roche Diagnostics Corp. | 2006 | — |
| +2 | K160712 | VITROS Chemistry Products hsCRP Reagent | Ortho Clinical Diagnostics | 2017 | — |
| +2 | K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | 2026 | — |
| +3 | K191993 | Yumizen C1200 CRP | Horiba Abx Sas | 2019 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K003400 | CRP HS Test SystemSummary page 1…(latex) HS Test System is substantially equivalent to device the currently marketed Roche Tina-quant® CRP (latex) HS Test System cleared under K003400. For purposes of the extended intended use, we claim equivalence to the currently marketed Dade Behring N High S… | 2001 |
| * | K033908 | N High Sensitivity CRPSummary page 1…K003400. For purposes of the extended intended use, we claim equivalence to the currently marketed Dade Behring N High Sensitivity CRP (K033908) Device The Tina-quant® CRP (latex) HS Test System is a latex particle-enhanced Description immunoturbidimetric… | 2004 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2016 | Class II | Z-1092-2017 | Under Investigation by firm | 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 ANALYTICS P module. this issue can… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K103557 (Diazyme Laboratories, 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K003400.
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 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…
Read the full statement (110 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042485 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042485: Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042485
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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