510(k) · Cleared
ClearedRoche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics Tina-Quant D-Dimer on Hitachi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Mar 16, 2001 after a 198-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Mar 16, 2001
- Review
- 198 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK002706 Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche…Roche Diagnostics Corp. · 2001
- Descendant · cites it directly · 3 of its ownK030740 Modification to Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp. · 2003
- Descendant · 2 generations on · 1 of its ownK062203 Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp. · 2007 · Recalled
- Descendant · 3 generations on · 0 of its ownK112120 Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories · 2013
- Descendant · cites it directly · 0 of its ownK070453 Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator…Olympus Life & Material Science Europa GmbH (Irish · 2007
- Descendant · cites it directly · 0 of its ownK033491 Roche Diagnostics Cardiac D-Dimer Rapid Assay; Roche Diagnostics…Roche Diagnostics Corp. · 2004
Most influential descendants
Showing 5 of 5 · See all- K030740Modification to Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp. · 2003 · cites it directly3descendants
- K062203Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp. · 2007 · 2 generations on1descendant
- K112120Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories · 2013 · 3 generations on0descendants
- K070453Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033…Olympus Life & Material Science Europa GmbH (Irish · 2007 · cites it directly0descendants
- K033491Roche Diagnostics Cardiac D-Dimer Rapid Assay; Roche Diagnostics Cardiac D-Dimer ControlsRoche Diagnostics Corp. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002706 | Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics… | Roche Diagnostics Corp. | 2001 | — |
| +1 | K030740 | Modification to Tina-Quant D-Dimer Test System | Roche Diagnostics Corp. | 2003 | — |
| +2 | K062203 | Tina-Quant D-Dimer Test System | Roche Diagnostics Corp. | 2007 | 1 |
| +3 | K112120 | Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set | Diazyme Laboratories | 2013 | — |
| +1 | K070453 | Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model… | Olympus Life & Material Science Europa GmbH (Irish | 2007 | — |
| +1 | K033491 | Roche Diagnostics Cardiac D-Dimer Rapid Assay; Roche Diagnostics Cardiac… | Roche Diagnostics Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DAP? 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 DAP device
- #1 K253985 INNOVANCE® D-Dimer 2.0 (SMN 10873803)score 13.0 · 5 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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?
- Of its descendants, K030740 (Roche Diagnostics Corp., 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DAP devicesDAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DAP
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DAP
127in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DAP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DAP
2in 2025
MAUDE reports naming product code DAP, 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 | 2 | — | 0 | 4 |
| 2008 | 3 | 127 | 0 | 10 |
| 2009 | 1 | — | 0 | 13 |
| 2010 | 2 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 1 | — | 1 | 38 |
| 2016 | 2 | — | 0 | 20 |
| 2017 | 1 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 7 |
| 2022 | 0 | — | 0 | 30 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 2 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K002706 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002706: Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics Tina-Quant D-Dimer on Hitachi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002706
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026