# K110303: Stratus CS Acute Care D-Dimer

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: May 16, 2011 after 104 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: 5 generations back to K862156 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093626: Innovance D-Dimer, Model OPBP09, Siemens Healthcare Diagnostics (2010) Summary page 1.

## Recalls of this device
- Nov 11, 2015 · Class II · Z-0611-2016: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

## Indications for use
The Stratus® CS Acute CareTM 0-dimer assay (DDMR) is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma on the 'Stratus® CS analyzer.. The Stratus® CS Acute CareTm DDMR 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 (PEf]. This assay is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings

Source page: https://510kreport.com/device/K110303
Methodology: https://510kreport.com/methodology