510(k) · Cleared
Recalled · Class II · 2023Tina-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 Mar 14, 2007 as substantially equivalent to K030740 (Roche Diagnostics Corp., 2003) and 1 other predicate after a 225-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 14, 2007
- Review
- 225 days
- Class
- Class II
- Product code
- GHH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K862156 (1986). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 3 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 2 generations backK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- 1 generation backK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
- This deviceK062203 Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp. · 2007
- Descendant · cites it directly · 0 of its ownK112120 Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories · 2013
Most influential descendants
Showing 1 of 1 · See all- K112120Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −3 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −2 | K020810 | Vidas D-Dimer New (DD2) Assay Model#30 442 | bioMerieux, Inc. | 2002 | — |
| −1 | K040882 | Vidas D-Dimer Exclusion Assay, Model 30 442 | bioMerieux, Inc. | 2004 | — |
| 0 (this device) | K062203 | Tina-Quant D-Dimer Test System | Roche Diagnostics Corp. | 2007 | — |
| +1 | K112120 | Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set | Diazyme Laboratories | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K030740 | Modification to Tina-Quant D-Dimer Test SystemSummary page 2…other products in commercial distribution. We claim equivalence to the currently marketed Tina-quant® D- Dimer Test System cleared under K030740. For purposes of the intended use extension, we also claim equivalence to the Biomerieux Vidas ® D-Dimer… | 2003 |
| * | K040882 | Vidas D-Dimer Exclusion Assay, Model 30 442 Our reading of the summary gave K040822, FDA’s number for Liquichek Torch Plus Igm Control (Bio-Rad Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Biomerieux Vidas D-Dimer Exclusion Assay”. | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112120 | Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2023 | Class II | Z-0352-2024 | Under Investigation by firm | Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K112120 (Diazyme Laboratories, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030740.
How does its category compare?
All GHH devicesGHH Fibrin Split Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
For Roche/Hitachi Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. Inconjunction with a non-high clinical probability assessment, a normal (< 0.5 pg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity. For COBAS Integra: The cassette COBAS Integra Tina-Quant® D-Dimer contains an in vitro diagnostic reagent system…
Read the full statement (107 words)
For Roche/Hitachi Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. Inconjunction with a non-high clinical probability assessment, a normal (< 0.5 pg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.
For COBAS Integra: The cassette COBAS Integra Tina-Quant® D-Dimer contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of fibrin degradation products (D-Dimer and X-oligomers) in plasma. Inconjunction with a non-high clinical probability assessment, a normal (< 0.5 pg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062203 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062203: 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/K062203
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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