510(k) · Cleared
ClearedMda D-Dimer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organon Teknika Corp. · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Apr 16, 1998 as substantially equivalent to K912876 (Organon Teknika Corp., 1991) and 1 other predicate after a 115-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Apr 16, 1998
- Review
- 115 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912876 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912876 Fibrinostika FBDP Microelisa SystemOrganon Teknika Corp. · 1991
- This deviceK974776 Mda D-DimerOrganon Teknika Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912876 | Fibrinostika FBDP Microelisa System | Organon Teknika Corp. | 1991 | — |
| 0 (this device) | K974776 | Mda D-Dimer | Organon Teknika Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K912876 | Fibrinostika FBDP Microelisa SystemSummary page 1…) An identification of the legally marketed device to which the submitter claims substantial equivalence, Device Equivalent to: 1. Fibrinostika® FbDP Microelisa System (K912876) 2, Dimertest® Gold EIA (K945642) (a) (4) A description of the device(System) Organon Teknika’'s MDA®D-Dimer is a homogeneous la… | 1991 |
| * | K945642 | Agen Dimertest Gold EiaSummary page 1…y marketed device to which the submitter claims substantial equivalence, Device Equivalent to: 1. Fibrinostika® FbDP Microelisa System (K912876) 2, Dimertest® Gold EIA (K945642) (a) (4) A description of the device(System) Organon Teknika’'s MDA®D-Dimer is a homogeneous latex particle based immunoassay (L… | 1995 |
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?
- None of the 2 ancestors has a recall.
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?
MDA® D-Dimer is a homogeneous latex particle based immunoassay Lia) for the quantitative determination of cross-linked fibrin degradation products containing the D-dimer domain in citra uman plasma. The assay is designed for use on the MDA® 180 automated coagulation analyzer.
D-dimer is elevated in disseminated intravascular coagulation {DIC), deep venous thrombosis (DVT), and pulmonary embolism.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974776: Mda D-Dimer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974776
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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