510(k) · Cleared
ClearedDiazyme D-Dimer Assay Kit,Calibrator Setand Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · GHH Fibrin Split Products
Cleared on Jan 24, 2013 as substantially equivalent to K062203 (Roche Diagnostics Corp., 2007) after a 549-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Jan 24, 2013
- Review
- 549 days
- Class
- Class II
- Product code
- GHH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K862156 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 4 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 3 generations backK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- 2 generations backK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
- 1 generation backK062203 Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp. · 2007 · Recalled
- This deviceK112120 Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −4 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −3 | K020810 | Vidas D-Dimer New (DD2) Assay Model#30 442 | bioMerieux, Inc. | 2002 | — |
| −2 | K040882 | Vidas D-Dimer Exclusion Assay, Model 30 442 | bioMerieux, Inc. | 2004 | — |
| −1 | K062203 | Tina-Quant D-Dimer Test System | Roche Diagnostics Corp. | 2007 | 1 |
| 0 (this device) | 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 |
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? (1)
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.
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 27 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All GHH devicesGHH Fibrin Split Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The D-Dimer Assay is for the quantitative determination of fibrinogen/fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only.
The Diayzme D-Dimer Assay Calibrator Set is intended for use in the calibration of the D-Dimer assay only. For in vitro diagnostic use only.
The Diazyme D-Dimer Assay Control Set is intended for use as quality controls for the Diazyme D-Dimer assay only. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112120: Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112120
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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