510(k) · Cleared
ClearedSigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Diagnostics, Inc. · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Nov 15, 2001 as substantially equivalent to K003329 (Sigma Diagnostics, Inc., 2001) after a 22-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 15, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003329 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003329 Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217Sigma Diagnostics, Inc. · 2001
- This deviceK013544 Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217 | Sigma Diagnostics, Inc. | 2001 | — |
| 0 (this device) | K013544 | Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096 | Sigma Diagnostics, Inc. | 2001 | — |
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? (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 |
|---|---|---|---|
| * | K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217Summary page 1…TO D-Dimer Control, Level 2 (Cat. No. A8096) has been demonstrated by its substantial equivalence to the Slgma Diagnostics AUTO D-Dimer Control, Level 2 (Cat. No. A5217, K003329). Sigma Diagnostics AUTO D-Dimer Control, Level 2 is a lyophilized human plasma based product. After reconstitution with water,… | 2001 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K003329.
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?
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in D-dimer agglutination assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
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/K013544 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013544: Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013544
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026