510(k) · Cleared
Recalled · Class III · 2012Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak
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 Mar 23, 2007 as substantially equivalent to K022976 (Dade Behring, Inc., 2003) and 2 other predicates after a 136-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 23, 2007
- Review
- 136 days
- Class
- Class II
- Product code
- DAP
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K862156 (1986). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 3 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 2 generations backK022976 Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr &…Dade Behring, Inc. · 2003 · Recalled
- 1 generation backK051597 Stratus CS D-DimerDade Behring, Inc. · 2005 · Recalled
- This deviceK063356 Stratus CS Acute Care D-Dimer Testpak, Dilpak, CalpakDade Behring, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK081732 Innovance D-Dimer and Innovance D-Dimer ControlsSiemens Healthcare Diagnostics · 2008
Most influential descendants
Showing 1 of 1 · See all- K081732Innovance D-Dimer and Innovance D-Dimer ControlsSiemens Healthcare Diagnostics · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −3 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −2 | K022976 | Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D | Dade Behring, Inc. | 2003 | 1 |
| −1 | K051597 | Stratus CS D-Dimer | Dade Behring, Inc. | 2005 | 1 |
| 0 (this device) | K063356 | Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak | Dade Behring, Inc. | 2007 | — |
| +1 | K081732 | Innovance D-Dimer and Innovance D-Dimer Controls | Siemens Healthcare Diagnostics | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 2…ilPak 3. Identification of the Predicate Device * Dade Behring Stratus® CS DDMR TestPak and DilPak K022976/K051597 * Dade Behring Stratus® CS DDMR CalPak K022977 FDA Guidance Document(s):… | 2003 |
| * | K051597 | Stratus CS D-DimerSummary page 2…3. Identification of the Predicate Device * Dade Behring Stratus® CS DDMR TestPak and DilPak K022976/K051597 * Dade Behring Stratus® CS DDMR CalPak K022977 FDA Guidance Document(s):… | 2005 |
| * | K022977 | Stratus CS D-Dimer Calpak Calibrator, Model Cddmr-CSummary page 2…* Dade Behring Stratus® CS DDMR TestPak and DilPak K022976/K051597 * Dade Behring Stratus® CS DDMR CalPak K022977 FDA Guidance Document(s): '"Bundling Multiple Devices or Multiple Indications in a Single… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081732 | Innovance D-Dimer and Innovance D-Dimer Controls | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2012 | Class III | Z-2283-2012 | Nonconforming Material/Component | 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 calibration failures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K081732 (Siemens Healthcare Diagnostics, 2008) has gone furthest, with 0 descendants 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. 2007, 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 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…
Read the full statement (156 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063356 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063356: Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063356
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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