510(k) · Cleared
ClearedOlympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033, Olympus D-Dimer Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Life & Material Science Europa GmbH (Irish · GHH Fibrin Split Products
Cleared on Jun 11, 2007 as substantially equivalent to K030740 (Roche Diagnostics Corp., 2003) and 1 other predicate after a 115-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jun 11, 2007
- Review
- 115 days
- Class
- Class II
- Product code
- GHH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002706 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK002706 Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche…Roche Diagnostics Corp. · 2001
- 1 generation backK030740 Modification to Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp. · 2003
- This deviceK070453 Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator…Olympus Life & Material Science Europa GmbH (Irish · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | 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 |
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 1…e D-Dimer Calibrator Control Roche D-Dimer Control I/Il Submitted (K030740 & K002706) 4. Device description In this Olympus procedure, the decrease in light intensity… | 2003 |
| * | K002706 | Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics Tina-Quant…Summary page 1…Calibrator Control Roche D-Dimer Control I/Il Submitted (K030740 & K002706) 4. Device description In this Olympus procedure, the decrease in light intensity trans… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 3 ancestors has a recall.
- 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?
System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers.
Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070453: Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033, Olympus D-Dimer Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070453
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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