510(k) · Cleared
Recalled · 2006Stratus CS D-Dimer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Aug 17, 2005 as substantially equivalent to K022976 (Dade Behring, Inc., 2003) after a 62-day review. Its family tree reaches back 3 generations to 1986. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 17, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- DAP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K862156 (1986). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 2 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 1 generation backK022976 Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr &…Dade Behring, Inc. · 2003 · Recalled
- This deviceK051597 Stratus CS D-DimerDade Behring, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK063356 Stratus CS Acute Care D-Dimer Testpak, Dilpak, CalpakDade Behring, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK081732 Innovance D-Dimer and Innovance D-Dimer ControlsSiemens Healthcare Diagnostics · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −2 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −1 | K022976 | Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D | Dade Behring, Inc. | 2003 | 1 |
| 0 (this device) | K051597 | Stratus CS D-Dimer | Dade Behring, Inc. | 2005 | — |
| +1 | K063356 | Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak | Dade Behring, Inc. | 2007 | 1 |
| +2 | K081732 | Innovance D-Dimer and Innovance D-Dimer Controls | Siemens Healthcare Diagnostics | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
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 |
|---|---|---|---|
| * | K022976 | Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-DSummary page 1…(HE) Product Code: DAP 3. Identification of the Legally Marketed Device: Stratus® CS D-Dimer (DDMR) Assay (K022976) 4. Device Description: The Stratus® CS DDMR procedure is a two-site sandwich assay based upon solid phase… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063356 | Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak | 2007 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2006 | Not classified | Z-0877-06 | Other | 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 falsely elevated or depressed, and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K063356 (Dade Behring, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K022976.
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.
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 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)].
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051597: Stratus CS D-Dimer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051597
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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