510(k) · Cleared
ClearedVALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maine Standards Company, LLC · GGN Plasma, Coagulation Control
Cleared on Jan 5, 2017 as substantially equivalent to K152961 (Maine Standards Company, LLC, 2016) after a 99-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jan 5, 2017
- Review
- 99 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K964716 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK964716 Sta Liatest Control [N]+[P] KitAmerican Bioproducts Co. · 1997
- 5 generations backK030182 Liquichek D-Dimer Control, Model 356, 357Bio-Rad · 2003
- 4 generations backK032017 Liquichek D-Dimer Control Level 1, 2 and 3Bio-Rad · 2003
- 3 generations backK050799 Triage (R) D-Dimer Calibration Verification Controls; Triage (R)…Biosite Incorporated · 2005
- 2 generations backK100716 Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd. · 2011
- 1 generation backK152961 VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2016
- This deviceK162705 VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K964716 | Sta Liatest Control [N]+[P] Kit | American Bioproducts Co. | 1997 | — |
| −5 | K030182 | Liquichek D-Dimer Control, Model 356, 357 | Bio-Rad | 2003 | — |
| −4 | K032017 | Liquichek D-Dimer Control Level 1, 2 and 3 | Bio-Rad | 2003 | — |
| −3 | K050799 | Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer… | Biosite Incorporated | 2005 | — |
| −2 | 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 | — |
| 0 (this device) | K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2017 | — |
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 |
|---|---|---|---|
| * | K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test KitSummary page 4…lass Il C. Predicate Device Identification: VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit. Maine Standards Company LLC, Cumberland Foreside, ME 04110 K152961 D. Candidate Device description: Each VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit contains one analyte set o… | 2016 |
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 20 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K152961.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte: D-Dimer in a clinical laboratory setting by laboratory personnel. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.
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/K162705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162705: VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162705
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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