# K022976: Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 16, 2003 after 132 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: 2 generations back to K862156 (1986). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973819: Vidas D-Dimer (DD) Assay, Biomerieux Vitek, Inc. (1998) Summary page 1.

## Most influential descendants
- K051597: Stratus CS D-Dimer (2005), 2 descendants of its own
- K040437: Triage Profiler S.O.B. Panel (2004), 2 descendants of its own
- 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
- K042723: Trigage Profiler S.O.B. Panel, Model 97300 (2004), 0 descendants of its own

## Recalls of this device
- Apr 3, 2006 · Not classified · Z-0883-06: Foil sealing of the DilPak 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 false

## Indications for use
The Dade Behring StratusB CS D-dimer method is an in vitro diagnostic test intended for use with the StratusB CS fluorometric analyzer for the determination of cross-linked fibrin degradation products (D-dimer) in plasma.

Source page: https://510kreport.com/device/K022976
Methodology: https://510kreport.com/methodology