510(k) · Cleared
ClearedVidas D-Dimer (DD) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux Vitek, Inc. · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Mar 10, 1998 as substantially equivalent to K862156 (American Bioproducts Co., 1986) after a 154-day review. Its family tree reaches back 1 generation to 1986. 1 of the 31 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it.
- Decided
- Mar 10, 1998
- Review
- 154 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862156 (1986). 29 later devices descend from it, 2 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- This deviceK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- Descendant · cites it directly · 21 of its ownK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- Descendant · 2 generations on · 19 of its ownK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
- Descendant · 3 generations on · 8 of its ownK070927 Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007
- Descendant · cites it directly · 6 of its ownK022976 Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr &…Dade Behring, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 2 of its ownK093626 Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics · 2010
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K042890 Triage D-Dimer Test, Model 981003 generations on · 2004
Most influential descendants
Showing 5 of 29 · See all- K020810Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002 · cites it directly21descendants
- K040882Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004 · 2 generations on19descendants
- K070927Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007 · 3 generations on8descendants
- K022976Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-DDade Behring, Inc. · 2003 · cites it directly6descendants
- K093626Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics · 2010 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| 0 (this device) | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| +1 | 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 | — |
| +3 | K070927 | Hemosil D-Dimer HS | Instrumentation Laboratory CO | 2007 | — |
| +1 | K022976 | Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D | Dade Behring, Inc. | 2003 | 1 |
| +3 | K093626 | Innovance D-Dimer, Model OPBP09 | Siemens Healthcare Diagnostics | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 1 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K862156 | Asserachrom D-DI KitSummary page 1…iserum, control (§1DAP) Common or Usual Name: Enzyme-linked Fluorescent Immunoassay (ELFA), D-Dimer (DD) Predicate Device: =~ American Bioproducts Asserachrom D-Di Kit (K862156) Intended Use: The VIDAS D-Dimer (DD) Assay is for the quantitative detection of . - fibrin degradation products (FbDP) in human… | 1986 |
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K042890Triage D-Dimer Test, Model 98100Biosite Incorporated · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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?
The VIDAS D-Dimer (DD) assay is intended for use with a VIDAS (Vitek ImmunoDiagnostic Assay System) instrument as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of fibrin degradation products (FbDP) in plasma (trisodium citrate). The VIDAS D-Dimer assay is intended for use as an aid in the diagnosis of deep venous thrombosis and pulmonary embolism disease.
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/K973819 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973819: Vidas D-Dimer (DD) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973819
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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