510(k) · Cleared
ClearedTina-Quant D-Dimer Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · GHH Fibrin Split Products
Cleared on May 29, 2001 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 29, 2001
- Review
- 46 days
- Class
- Class II
- Product code
- GHH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK011143 Tina-Quant D-Dimer Test SystemRoche 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 · 2 generations on · 0 of its ownK070453 Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator…Olympus Life & Material Science Europa GmbH (Irish · 2007
Most influential descendants
Showing 4 of 4 · 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011143 | Tina-Quant D-Dimer Test System | 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 | — |
| +2 | K070453 | Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model… | Olympus Life & Material Science Europa GmbH (Irish | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 GHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030740 | Modification to Tina-Quant D-Dimer Test System | 2003 | 3 |
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 GHH devicesGHH Fibrin Split Products: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GHH
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · GHH
Too few GHH 510(k)s in any year since 2007 to give a median.
Recalls per year · GHH
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GHH
3in 2025
MAUDE reports naming product code GHH, 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 | — | 1 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 1 | 12 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 2 | 8 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K011143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011143: Tina-Quant D-Dimer Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011143
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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