510(k) · Cleared
ClearedAudit Microcv D-Dimer Linearity Set, Model K717M-5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aalto Scientific, Ltd. · GGN Plasma, Coagulation Control
Cleared on Jun 23, 2011 as substantially equivalent to K050799 (Biosite Incorporated, 2005) after a 468-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it.
- Decided
- Jun 23, 2011
- Review
- 468 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K964716 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK964716 Sta Liatest Control [N]+[P] KitAmerican Bioproducts Co. · 1997
- 3 generations backK030182 Liquichek D-Dimer Control, Model 356, 357Bio-Rad · 2003
- 2 generations backK032017 Liquichek D-Dimer Control Level 1, 2 and 3Bio-Rad · 2003
- 1 generation backK050799 Triage (R) D-Dimer Calibration Verification Controls; Triage (R)…Biosite Incorporated · 2005
- This deviceK100716 Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd. · 2011
- Descendant · cites it directly · 2 of its ownK152961 VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK170864 VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK162705 VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2017
Most influential descendants
Showing 3 of 3 · See all- K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2016 · cites it directly2descendants
- K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC · 2017 · 2 generations on0descendants
- K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964716 | Sta Liatest Control [N]+[P] Kit | American Bioproducts Co. | 1997 | — |
| −3 | K030182 | Liquichek D-Dimer Control, Model 356, 357 | Bio-Rad | 2003 | — |
| −2 | K032017 | Liquichek D-Dimer Control Level 1, 2 and 3 | Bio-Rad | 2003 | — |
| −1 | K050799 | Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer… | Biosite Incorporated | 2005 | — |
| 0 (this device) | K100716 | Audit Microcv D-Dimer Linearity Set, Model K717M-5 | Aalto Scientific, Ltd. | 2011 | — |
| +1 | K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | 2016 | — |
| +2 | K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | Maine Standards Company, LLC | 2017 | — |
| +2 | K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 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 GGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K050799 | Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer ControlsSummary page 1…Triage® D-Dimer Calibration Verification Controls Biosite Incorporated, San Diego, CA 92121 K050799 Page 3 of 26 510(k) Not… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | 2016 | 2 |
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 14 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K152961 (Maine Standards Company, LLC, 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GGN
4in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · GGN
96in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGN
4in 2018
MAUDE reports naming product code GGN, 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 | 3 | 47 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 37 |
| 2010 | 3 | 23 | 4 | 17 |
| 2011 | 2 | — | 1 | 30 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 3 | 441 | 3 | 9 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 96 | 0 | 11 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The AuditTM MicroCVTM D-Dimer Linearity Set is a quantitative, assayed quality control material consisting of five levels of D-dimer analyte. The five D-dimer levels demonstrate a linear relationship to each other for D-dimer analyte. The AuditTM MicroCVTM D-Dimer Linearity Set is intended to use with the Biomerieux miniVIDAS® analyzer and VIDAS® D-dimer assay to verify the calibration of the measuring range. AuditTM MicroCVTM D-Dimer Linearity Set is "For In Vitro Diagnostic Use Only."
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100716: Audit Microcv D-Dimer Linearity Set, Model K717M-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100716
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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