# K091916: Innovance D-Dimer, Model OPBP09

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Oct 29, 2009 after 121 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: 4 generations back to K862156 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040882: Vidas D-Dimer Exclusion Assay, Model 30 442, bioMerieux, Inc. (2004) Summary page 1.

## Indications for use
For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Healthcare Diagnostics and Sysmex® Coagulation Systems. The INNOVANCE® D-Dimer assay is intended for use in conjunction with a non-high clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) disease and as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

Source page: https://510kreport.com/device/K091916
Methodology: https://510kreport.com/methodology