# K063356: Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 23, 2007 after 136 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: 4 generations back to K862156 (1986). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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 2.
- K051597: Stratus CS D-Dimer, Dade Behring, Inc. (2005) Summary page 2.
- K022977: Stratus CS D-Dimer Calpak Calibrator, Model Cddmr-C, Dade Behring, Inc. (2002) Summary page 2.

## Most influential descendants
- K081732: Innovance D-Dimer and Innovance D-Dimer Controls (2008), 0 descendants of its own

## Recalls of this device
- Jun 7, 2012 · Class III · Z-2283-2012: Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), which indicate calibra

## Indications for use
The Stratus® CS Acute CareTM D-dimer (DDMR) method 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 Acute CareTM DDMR method is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings. The Stratus® CS Acute CareTM D-dimer Calibrator (DDMR CalPak) Catalog. No. CDDMR-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute CareTM D-dimer (DDMR) method. The Stratus® CS Acute CareTM D-dimer Dilution Pak (DDMR DilPak), Catalog. No. CDDMR-D, is an in vitro diagnostic product intended to be used in conjunction with the Acute CareTM DDMR TestPak, Catalog. No. CDDMR for the measurement of samples with elevated levels of D-Dimer.

Source page: https://510kreport.com/device/K063356
Methodology: https://510kreport.com/methodology