510(k) · Cleared
Recalled · 2006Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D
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 Jan 16, 2003 as substantially equivalent to K973819 (Biomerieux Vitek, Inc., 1998) after a 132-day review. Its family tree reaches back 2 generations to 1986. 1 of the 9 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled once.
- Decided
- Jan 16, 2003
- Review
- 132 days
- Class
- Class II
- Product code
- DAP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K862156 (1986). 6 later devices descend from it, 3 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 1 generation backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- This deviceK022976 Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr &…Dade Behring, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK051597 Stratus CS D-DimerDade Behring, Inc. · 2005 · Recalled
- Descendant · cites it directly · 2 of its ownK040437 Triage Profiler S.O.B. PanelBiosite Incorporated · 2004
- 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
- Descendant · 2 generations on · 0 of its ownK042723 Trigage Profiler S.O.B. Panel, Model 97300Biosite Incorporated · 2004
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K042890 Triage D-Dimer Test, Model 981002 generations on · 2004
Most influential descendants
Showing 5 of 6 · See all- K051597Stratus CS D-DimerDade Behring, Inc. · 2005 · cites it directly2descendants
- K040437Triage Profiler S.O.B. PanelBiosite Incorporated · 2004 · cites it directly2descendants
- K063356Stratus CS Acute Care D-Dimer Testpak, Dilpak, CalpakDade Behring, Inc. · 2007 · cites it directly1descendant
- K081732Innovance D-Dimer and Innovance D-Dimer ControlsSiemens Healthcare Diagnostics · 2008 · 2 generations on0descendants
- K042723Trigage Profiler S.O.B. Panel, Model 97300Biosite Incorporated · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −1 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| 0 (this device) | K022976 | Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D | Dade Behring, Inc. | 2003 | — |
| +1 | K051597 | Stratus CS D-Dimer | Dade Behring, Inc. | 2005 | 1 |
| +1 | K040437 | Triage Profiler S.O.B. Panel | Biosite Incorporated | 2004 | — |
| +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 | — |
| +2 | K042723 | Trigage Profiler S.O.B. Panel, Model 97300 | Biosite Incorporated | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 1 |
| 2005 | 1 | 0 |
| 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K973819 | Vidas D-Dimer (DD) AssaySummary page 1…DilPak (diluent) FDA Classification Name: Fibrinogenifibrin degradation products assay Predicate Device: bioMerieux Vitek VIDASO D-dimer Assay (K9738 19) Device Description: The Dade Behring Stratus@ CS D-dimer TestPak method is an enzy… | 1998 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2006 | Not classified | Z-0883-06 | Other | Foil sealing of the DilPak 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… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K042890Triage D-Dimer Test, Model 98100Biosite Incorporated · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051597 (Dade Behring, Inc., 2005) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K973819.
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 Dade Behring StratusB CS D-dimer method is an in vitro diagnostic test intended for use with the StratusB CS fluorometric analyzer for the determination of cross-linked fibrin degradation products (D-dimer) in plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022976 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022976: Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022976
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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