# K030328: Vidas D-Dimer New (DD2) Assay, Model 30 442

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 2, 2003 after 214 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.
No later device cites it as a predicate yet.
0 of 4 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)

## Indications for use
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.

Source page: https://510kreport.com/device/K030328
Methodology: https://510kreport.com/methodology