# K040882: Vidas D-Dimer Exclusion Assay, Model 30 442

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 10, 2004 after 66 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K862156 (1986). 3 ancestors in all.
19 later devices descend from it; 9 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020810: Vidas D-Dimer New (DD2) Assay Model#30 442, bioMerieux, Inc. (2002) Summary page 1.

## Most influential descendants
- K070927: Hemosil D-Dimer HS (2007), 8 descendants of its own
- K093626: Innovance D-Dimer, Model OPBP09 (2010), 2 descendants of its own
- K083518: Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls (2009), 2 descendants of its own
- K151534: HemosIL D-Dimer HS (2015), 1 descendant of its own
- K112818: Vidas D-Dimer Exclusion II (DEX2) (2012), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K040882
Methodology: https://510kreport.com/methodology