510(k) · Cleared
ClearedLiquichek D-Dimer Control Level 1, 2 and 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · GGN Plasma, Coagulation Control
Cleared on Aug 8, 2003 as substantially equivalent to K030182 (Bio-Rad, 2003) after a 39-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- Aug 8, 2003
- Review
- 39 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964716 (1997). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK964716 Sta Liatest Control [N]+[P] KitAmerican Bioproducts Co. · 1997
- 1 generation backK030182 Liquichek D-Dimer Control, Model 356, 357Bio-Rad · 2003
- This deviceK032017 Liquichek D-Dimer Control Level 1, 2 and 3Bio-Rad · 2003
- Descendant · cites it directly · 4 of its ownK050799 Triage (R) D-Dimer Calibration Verification Controls; Triage (R)…Biosite Incorporated · 2005
- Descendant · 2 generations on · 3 of its ownK100716 Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd. · 2011
- Descendant · 3 generations on · 2 of its ownK152961 VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2016
- Descendant · 4 generations on · 0 of its ownK170864 VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC · 2017
- Descendant · 4 generations on · 0 of its ownK162705 VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2017
Most influential descendants
Showing 5 of 5 · See all- K050799Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer ControlsBiosite Incorporated · 2005 · cites it directly4descendants
- K100716Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd. · 2011 · 2 generations on3descendants
- K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2016 · 3 generations on2descendants
- K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC · 2017 · 4 generations on0descendants
- K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964716 | Sta Liatest Control [N]+[P] Kit | American Bioproducts Co. | 1997 | — |
| −1 | K030182 | Liquichek D-Dimer Control, Model 356, 357 | Bio-Rad | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K100716 | Audit Microcv D-Dimer Linearity Set, Model K717M-5 | Aalto Scientific, Ltd. | 2011 | — |
| +3 | K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | 2016 | — |
| +4 | K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | Maine Standards Company, LLC | 2017 | — |
| +4 | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K030182 | Liquichek D-Dimer Control, Model 356, 357Summary page 2…ate Device The new LiquichekTMD-dimer Control claims substantial equivalence to the Liquichekm D-dimer Control currently in commercial distribution (K030182). The new Liquichekm D- dimer Control is a tri-level (Level 1, 2 and 3) product and the current product is a bi-level… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050799 | Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer Controls | 2005 | 4 |
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 6 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K050799 (Biosite Incorporated, 2005) has gone furthest, with 4 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.
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?
Liquichek Ddimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for Ddimer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032017: Liquichek D-Dimer Control Level 1, 2 and 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032017
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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