510(k) · Cleared
ClearedModification to Tina-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 Apr 1, 2003 as substantially equivalent to K002706 (Roche Diagnostics Corp., 2001) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Apr 1, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- GHH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002706 (2001). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002706 Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche…Roche Diagnostics Corp. · 2001
- This deviceK030740 Modification to Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 1 of its ownK062203 Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp. · 2007 · Recalled
- Descendant · 2 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
Most influential descendants
Showing 3 of 3 · See all- K062203Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp. · 2007 · cites it directly1descendant
- K112120Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories · 2013 · 2 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002706 | Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics… | Roche Diagnostics Corp. | 2001 | — |
| 0 (this device) | K030740 | Modification to Tina-Quant D-Dimer Test System | Roche Diagnostics Corp. | 2003 | — |
| +1 | K062203 | Tina-Quant D-Dimer Test System | Roche Diagnostics Corp. | 2007 | 1 |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2013 | 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 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? (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 |
|---|---|---|---|
| * | K002706 | Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics Tina-Quant…Summary page 2…Tina-quantB D-dimer Tina-quantB D-dimer on Roche Hitachi on COBAS Integra (Modified Device) (K002706) (KO11143) Intended Use Immunoturbidimetric The cassette COBAS Same assay for… | 2001 |
| * | K011143 | Tina-Quant D-Dimer Test System | 2001 |
What descends from it? (3)
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?
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 | — |
What is it indicated for?
Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers in plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030740 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030740: Modification to Tina-Quant D-Dimer Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030740
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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