# K081732: Innovance D-Dimer and Innovance D-Dimer Controls

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Oct 24, 2008 after 127 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: 5 generations back to K862156 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063356: Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak, Dade Behring, Inc. (2007) Summary page 1.
- K992957: Advanced D-Dimer, Dade Behring, Inc. (2000). Our reading of the summary gave K992956, FDA’s number for Lucitone FRS Flexibel Dental Resin (Dentsply Intl.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Advanced D-Dimer Controls 1 and 2”.

## Indications for use
INNOVANCE™ D-Dimer: For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on the Dade Behring and Sysmex Coagulation Systems. The INNOVANCE™ D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]. INNOVANCE™ D-Dimer Controls: INNOVANCE™ D-Dimer Control 1 and INNOVANCE™ D-Dimer Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on the Dade Behring and Sysmex Coagulation Systems.

Source page: https://510kreport.com/device/K081732
Methodology: https://510kreport.com/methodology