510(k) · Cleared
ClearedAsserachrom D-DI Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bioproducts Co. · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Sep 16, 1986 after a 103-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 34 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it.
- Decided
- Sep 16, 1986
- Review
- 103 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 3 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- This deviceK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- Descendant · cites it directly · 29 of its ownK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- Descendant · 2 generations on · 21 of its ownK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- Descendant · 3 generations on · 19 of its ownK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
- Descendant · 4 generations on · 8 of its ownK070927 Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007
- Descendant · 2 generations on · 6 of its ownK022976 Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr &…Dade Behring, Inc. · 2003 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K042890 Triage D-Dimer Test, Model 981004 generations on · 2004
Most influential descendants
Showing 5 of 33 · See all- K973819Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998 · cites it directly29descendants
- K020810Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002 · 2 generations on21descendants
- K040882Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004 · 3 generations on19descendants
- K070927Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007 · 4 generations on8descendants
- K022976Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-DDade Behring, Inc. · 2003 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| +1 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| +2 | K020810 | Vidas D-Dimer New (DD2) Assay Model#30 442 | bioMerieux, Inc. | 2002 | — |
| +3 | K040882 | Vidas D-Dimer Exclusion Assay, Model 30 442 | bioMerieux, Inc. | 2004 | — |
| +4 | K070927 | Hemosil D-Dimer HS | Instrumentation Laboratory CO | 2007 | — |
| +2 | K022976 | Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D | Dade Behring, Inc. | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 1 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (33)
See all 333 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)
No FDA recall names this device.
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 · 4 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K973819 (Biomerieux Vitek, Inc., 1998) has gone furthest, with 29 descendants of its own.
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 | — |
https://510kreport.com/device/K862156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K862156: Asserachrom D-DI Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862156
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026