510(k) · Cleared
ClearedVidas D-Dimer New (DD2) Assay, Model 30 442
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Sep 2, 2003 as substantially equivalent to K020810 (bioMerieux, Inc., 2002) after a 214-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Sep 2, 2003
- Review
- 214 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K862156 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 2 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 1 generation backK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- This deviceK030328 Vidas D-Dimer New (DD2) Assay, Model 30 442bioMerieux, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −2 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −1 | K020810 | Vidas D-Dimer New (DD2) Assay Model#30 442 | bioMerieux, Inc. | 2002 | — |
| 0 (this device) | K030328 | Vidas D-Dimer New (DD2) Assay, Model 30 442 | bioMerieux, Inc. | 2003 | — |
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 DAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DAP device
- #1 K253985 INNOVANCE® D-Dimer 2.0 (SMN 10873803)score 13.0 · 5 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020810 | Vidas D-Dimer New (DD2) Assay Model#30 442 | 2002 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K020810.
How does its category compare?
All DAP devicesDAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DAP
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DAP
127in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DAP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DAP
2in 2025
MAUDE reports naming product code DAP, 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 | — | 0 | 4 |
| 2008 | 3 | 127 | 0 | 10 |
| 2009 | 1 | — | 0 | 13 |
| 2010 | 2 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 1 | — | 1 | 38 |
| 2016 | 2 | — | 0 | 20 |
| 2017 | 1 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 7 |
| 2022 | 0 | — | 0 | 30 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
VIDAS D-Dimer New is an automated, quantitative test for use on the VIDAS analyzer for the immunoenzymatic determination of cross-linked fibrin degradation products (FbDP) containing the Ddimer domain in citrated human plasma using the Enzyme Linked Fluorescent Assay (ELFA) technique. VIDAS D-Dimer New is indicated for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030328: Vidas D-Dimer New (DD2) Assay, Model 30 442.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030328
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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