510(k) · Cleared
Recalled · Class II · 2015Stratus CS Acute Care D-Dimer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on May 16, 2011 as substantially equivalent to K093626 (Siemens Healthcare Diagnostics, 2010) after a 104-day review. Its family tree reaches back 5 generations to 1986. It has been recalled once.
- Decided
- May 16, 2011
- Review
- 104 days
- Class
- Class II
- Product code
- DAP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K862156 (1986). No later device cites it as a predicate yet.
- Root · 5 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 4 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 3 generations backK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- 2 generations backK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
- 1 generation backK093626 Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics · 2010
- This deviceK110303 Stratus CS Acute Care D-DimerSiemens Healthcare Diagnostics · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −4 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −3 | K020810 | Vidas D-Dimer New (DD2) Assay Model#30 442 | bioMerieux, Inc. | 2002 | — |
| −2 | K040882 | Vidas D-Dimer Exclusion Assay, Model 30 442 | bioMerieux, Inc. | 2004 | — |
| −1 | K093626 | Innovance D-Dimer, Model OPBP09 | Siemens Healthcare Diagnostics | 2010 | — |
| 0 (this device) | K110303 | Stratus CS Acute Care D-Dimer | Siemens Healthcare Diagnostics | 2011 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DAP device
- #1 K253985 INNOVANCE® D-Dimer 2.0 (SMN 10873803)score 13.0 · 5 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093626 | Innovance D-Dimer, Model OPBP09Summary page 1…Hematology (HE) Product Code: DAP 3. Identification of the Legally Marketed Device: Innovance 0-Dimer - K093626 4. Device Description: The Stratus® CS Acute Care D-Dimer method is a two-site sandwich assay based… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2015 | Class II | Z-0611-2016 | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K093626.
How does its category compare?
All DAP devicesDAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DAP
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DAP
127in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DAP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DAP
2in 2025
MAUDE reports naming product code DAP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 4 |
| 2008 | 3 | 127 | 0 | 10 |
| 2009 | 1 | — | 0 | 13 |
| 2010 | 2 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 1 | — | 1 | 38 |
| 2016 | 2 | — | 0 | 20 |
| 2017 | 1 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 7 |
| 2022 | 0 | — | 0 | 30 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110303: Stratus CS Acute Care D-Dimer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110303
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026