510(k) Report

510(k) · Cleared

Cleared

Vidas D-Dimer Exclusion Assay, Model 30 442

K040882510(k) TraditionalCleared Jun 10, 200466-day reviewClass II21 CFR 864.7320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

bioMerieux, Inc. · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Cleared on Jun 10, 2004 as substantially equivalent to K020810 (bioMerieux, Inc., 2002) after a 66-day review. Its family tree reaches back 3 generations to 1986. 19 later devices descend from it.

Decided
Jun 10, 2004
Review
66 days
Class
Class II
Product code
DAP
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K862156 (1986). 19 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2016: 2 descendants cleared2009: 2 descendants cleared2014: 1 descendant cleared2012: 1 descendant cleared2010: 2 descendants cleared2013: 1 descendant cleared2008: 1 descendant cleared2015: 2 descendants cleared2017: 2 descendants cleared2023: 1 descendant cleared2011: 1 descendant cleared2026: 1 descendant clearedK862156 · Asserachrom D-DI Kit · American Bioproducts Co. · 1986K973819 · Vidas D-Dimer (DD) Assay · Biomerieux Vitek, Inc. · 1998K020810 · Vidas D-Dimer New (DD2) Assay Model#30 442 · bioMerieux, Inc. · 20021990200020102020
Descendants, by generation 1 generation forward: 9 descendants2 generations forward: 9 descendants3 generations forward: 1 descendant K020810 · Vidas D-Dimer New (DD2) Assay Model#30 442 · bioMerieux, Inc. · 2002K973819 · Vidas D-Dimer (DD) Assay · Biomerieux Vitek, Inc. · 1998K862156 · Asserachrom D-DI Kit · American Bioproducts Co. · 19860
  1. Root · 3 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
  2. 2 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
  3. 1 generation backK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
  4. This deviceK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
  5. Descendant · cites it directly · 8 of its ownK070927 Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007
  6. Descendant · cites it directly · 2 of its ownK093626 Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics · 2010
  7. Descendant · cites it directly · 2 of its ownK083518 Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO · 2009
  8. Descendant · 2 generations on · 1 of its ownK151534 HemosIL D-Dimer HSInstrumentation Laboratory CO · 2015
  9. Descendant · cites it directly · 1 of its ownK112818 Vidas D-Dimer Exclusion II (DEX2)bioMerieux, Inc. · 2012 · Recalled

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2007: 22008: 12009: 22010: 22011: 12012: 12013: 12014: 12015: 22016: 22017: 22023: 12026: 1
2007high 2 (2007) · low 0 (2018)2026

Most influential descendants

Showing 5 of 19 · See all
  • K070927Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007 · cites it directly8descendants
  • K093626Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics · 2010 · cites it directly2descendants
  • K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO · 2009 · cites it directly2descendants
  • K151534HemosIL D-Dimer HSInstrumentation Laboratory CO · 2015 · 2 generations on1descendant
  • K112818Vidas D-Dimer Exclusion II (DEX2)bioMerieux, Inc. · 2012 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K862156Asserachrom D-DI KitAmerican Bioproducts Co.1986—
−2K973819Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc.1998—
−1K020810Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc.2002—
0 (this device)K040882Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc.2004—
+1K070927Hemosil D-Dimer HSInstrumentation Laboratory CO2007—
+1K093626Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics2010—
+1K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO2009—
+2K151534HemosIL D-Dimer HSInstrumentation Laboratory CO2015—
+1K112818Vidas D-Dimer Exclusion II (DEX2)bioMerieux, Inc.20121

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200810
200920
201020
201110
201210
201310
201410
201520
201620
201720
202310
202610
FIG. 1 — Lineage of K040882, 1986–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253985 INNOVANCE® D-Dimer 2.0 (SMN 10873803)score 13.0 · 5 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K020810Vidas D-Dimer New (DD2) Assay Model#30 442
Summary page 1
…Classification Name: Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control Predicate Device Trade Name: VIDAS D-Dimer (DD) New Assay, K020810 Device Description The VIDASt D-Dimer New (DD2) Assay is an automated quantitative test for use on the VIDAS instrument (K89138…
bioMerieux, Inc.2002—

Also cleared against K020810: 1 other device →

What descends from it? (19)

See all 19

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070927Hemosil D-Dimer HSInstrumentation Laboratory CO20078
K093626Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics20102
K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO20092
K112818Vidas D-Dimer Exclusion II (DEX2)bioMerieux, Inc.20121
K090264Hemosil D-Dimer HS 500, ControlsInstrumentation Laboratory CO20101
K062203Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp.20071
K162227STA® - Liatest® D-DiDiagnostica Stago20160
K141144Sta Liatest D-DIDiagnostica Stago20140
K091916Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics20090

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 18 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.
  • Of its descendants, K070927 (Instrumentation Laboratory CO, 2007) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K020810.

How does its category compare?

All DAP devices

DAP 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

2007: 22008: 32009: 12010: 22011: 12012: 12014: 12015: 12016: 22017: 12026 (partial year): 1
2007high 3 (2008) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DAP

127in 2008

2008: 127 days median
2007high 127 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DAP

2in 2025

2015: 12021: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DAP

2in 2025

2007: 42008: 102009: 132010: 92011: 142012: 102013: 82014: 92015: 382016: 202017: 172018: 52019: 92020: 112021: 72022: 302023: 42024: 12025: 2
2007high 38 (2015) · low 1 (2024)2025

MAUDE reports naming product code DAP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—04
20083127010
20091—013
20102—09
20111—014
20121—010
20130—08
20141—09
20151—138
20162—020
20171—017
20180—05
20190—09
20200—011
20210—17
20220—030
20230—04
20240—01
20250—22
20261—0—

What is it indicated for?

The VIDAS ® D-Dimer Exclusion assay is an automated quantitative test for use on the VIDAS analyzers for the immunocenzymatic determination of fibrin degradation products (FbDP) in citrated human plasma using the ELFA techniques (Enzyme Linked Fluorescent Assay). The VIDAS ® D-Dimer Exclusion assay is indicated for use in conjunction with a clinical Pre-test Probability Assessment (PTP) assessment model to exclude deep venous thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE.

Indications for use as stated in the FDA summary.

Also cleared against K020810

1 other device cites the same predicate.

  • K030328Vidas D-Dimer New (DD2) Assay, Model 30 442bioMerieux, Inc. · 2003

More from bioMerieux, Inc.

281 FDA decisions under this applicant name. See the company

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  • K234012Vitek Compact ProbioMerieux, Inc. · 2025

Recent decisions in DAP

The DAP category page

  • K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbH · 2026
  • K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO · 2017
  • K162227STA® - Liatest® D-DiDiagnostica Stago · 20162 recalls
  • K160885HemosIL D-Dimer HSInstrumentation Laboratory CO · 2016
  • K151534HemosIL D-Dimer HSInstrumentation Laboratory CO · 2015

https://510kreport.com/device/K040882 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040882: Vidas D-Dimer Exclusion Assay, Model 30 442.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040882

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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