# K051597: Stratus CS D-Dimer

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 17, 2005 after 62 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: 1 (0 Class I)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022976: Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D, Dade Behring, Inc. (2003) Summary page 1.

## Most influential descendants
- K063356: Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak (2007), 1 descendant of its own
- K081732: Innovance D-Dimer and Innovance D-Dimer Controls (2008), 0 descendants of its own

## Recalls of this device
- Apr 3, 2006 · Not classified · Z-0877-06: Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be fals

## Indications for use
The D-dimer (DDMR) method on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma. The Stratus® CS DDMR method is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

Source page: https://510kreport.com/device/K051597
Methodology: https://510kreport.com/methodology