510(k) · Cleared
ClearedInnovance D-Dimer and Innovance D-Dimer Controls
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 Oct 24, 2008 as substantially equivalent to K063356 (Dade Behring, Inc., 2007) and 1 other predicate after a 127-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Oct 24, 2008
- Review
- 127 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K862156 (1986). 7 ancestors in all. 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 backK022976 Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr &…Dade Behring, Inc. · 2003 · Recalled
- 2 generations backK051597 Stratus CS D-DimerDade Behring, Inc. · 2005 · Recalled
- 1 generation backK063356 Stratus CS Acute Care D-Dimer Testpak, Dilpak, CalpakDade Behring, Inc. · 2007 · Recalled
- This deviceK081732 Innovance D-Dimer and Innovance D-Dimer ControlsSiemens Healthcare Diagnostics · 2008
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 | K022976 | Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D | Dade Behring, Inc. | 2003 | 1 |
| −2 | K051597 | Stratus CS D-Dimer | Dade Behring, Inc. | 2005 | 1 |
| −1 | K063356 | Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak | Dade Behring, Inc. | 2007 | 1 |
| 0 (this device) | 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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K063356 | Stratus CS Acute Care D-Dimer Testpak, Dilpak, CalpakSummary page 1…Hematology (HE) Product Code: DAP 3. Identification of the Legally Marketed Device: Stratus® CS DDMVR TestPak, CalPak, DilPak- k063356 Advanced D-Dimer Controls 1 and 2 - k992956 4. Device Description: Polystyrene particles covalently coated… | 2007 |
| * | K992957 | Advanced D-Dimer Our reading of the summary gave K992956, FDA’s number for Lucitone FRS Flexibel Dental Resin (Dentsply Intl.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Advanced D-Dimer Controls 1 and 2”. | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
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. 2008, 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?
INNOVANCE™ D-Dimer:
For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on the Dade Behring and Sysmex Coagulation Systems. The INNOVANCE™ D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].
INNOVANCE™ D-Dimer Controls:
INNOVANCE™ D-Dimer Control 1 and INNOVANCE™ D-Dimer Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on the Dade Behring and Sysmex Coagulation Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081732: Innovance D-Dimer and Innovance D-Dimer Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081732
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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