# K973819: Vidas D-Dimer (DD) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Mar 10, 1998 after 154 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: 1 generation back to K862156 (1986). 1 ancestor in all.
29 later devices descend from it; 2 cite it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862156: Asserachrom D-DI Kit, American Bioproducts Co. (1986) Summary page 1.

## Most influential descendants
- K020810: Vidas D-Dimer New (DD2) Assay Model#30 442 (2002), 21 descendants of its own
- 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
- K022976: Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D (2003), 6 descendants of its own
- K093626: Innovance D-Dimer, Model OPBP09 (2010), 2 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K973819
Methodology: https://510kreport.com/methodology