# K033491: Roche Diagnostics Cardiac D-Dimer Rapid Assay; Roche Diagnostics Cardiac D-Dimer Controls

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 1, 2004 after 302 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 K002706 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002706: Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics Tina-Quant D-Dimer on Hitachi, Roche Diagnostics Corp. (2001) Summary page 1.

## Indications for use
The CARDIAC D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the CARDIAC Reader instrument. D-Dimer is a degradation product of crosslinked firbrin. The d-dimer concentration is a measure of the fibrinolytic activity of plasmin in the vascular system. Elevated concentrations of d-dimer indicate increased coagulatory and fibrinolytic activity. In general, a validated d-dimer assay may be useful in ruling out deep venous thrombosis or pulmonary embolism.

Source page: https://510kreport.com/device/K033491
Methodology: https://510kreport.com/methodology