# K020810: Vidas D-Dimer New (DD2) Assay Model#30 442

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 3, 2002 after 204 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: 2 generations back to K862156 (1986). 2 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973819: Vidas D-Dimer (DD) Assay, Biomerieux Vitek, Inc. (1998). Our reading of the summary gave K972819, FDA’s number for Vigil TDM Controls (Beckman Instruments, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VIDAS D-Dimer (DD) Assay”.

## Most influential descendants
- K040882: Vidas D-Dimer Exclusion Assay, Model 30 442 (2004), 19 descendants of its own
- 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

## Indications for use
The VIDAS D-Dimer New assay indicated for use as an aid in the diagnosis of deep venous thrombosis and pulmonary embolism disease.

Source page: https://510kreport.com/device/K020810
Methodology: https://510kreport.com/methodology