510(k) · Cleared
ClearedMGC Dau Control Sets: Primary, Clinical and Select
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DIF Drug Mixture Control Materials
Cleared on May 28, 2004 as substantially equivalent to K951135 (Microgenics Corp., 1995) after a 64-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- May 28, 2004
- Review
- 64 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951135 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK951135 Multi-Drug Control SetMicrogenics Corp. · 1995
- This deviceK040758 MGC Dau Control Sets: Primary, Clinical and SelectMicrogenics Corp. · 2004
- Descendant · cites it directly · 1 of its ownK081378 Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific · 2009
- Descendant · cites it directly · 0 of its ownK103656 Thermo Scientific Mas R Doa TotalMicrogenics Corporation · 2011
- Descendant · 2 generations on · 0 of its ownK092048 One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
Most influential descendants
Showing 3 of 3 · See all- K081378Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific · 2009 · cites it directly1descendant
- K103656Thermo Scientific Mas R Doa TotalMicrogenics Corporation · 2011 · cites it directly0descendants
- K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951135 | Multi-Drug Control Set | Microgenics Corp. | 1995 | — |
| 0 (this device) | K040758 | MGC Dau Control Sets: Primary, Clinical and Select | Microgenics Corp. | 2004 | — |
| +1 | K081378 | Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls | Thermo Fisher Scientific | 2009 | — |
| +1 | K103656 | Thermo Scientific Mas R Doa Total | Microgenics Corporation | 2011 | — |
| +2 | K092048 | One Step Eddp (Methadone Metabolite) Test Strip | Biosite Incorporated | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 DIF? 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 |
|---|---|---|---|
| * | K951135 | Multi-Drug Control SetSummary page 1…results enclosed herein demnonstrate that each configuration of the MGC DAU Control Sets is substantially equivalent in form and function to the Multi- Drug Control Set (K951 135) for its stated intended use. Device Description: Each configuration of the MGC DAU Control Sets is prepared in a… | 1995 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIF
35in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIF
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIF
1in 2016
MAUDE reports naming product code DIF, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 35 | 0 | 3 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 5 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MGC DAU Control Set consists of controls intended for use in the validation of drug of abuse assays performed using human urine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040758 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040758: MGC Dau Control Sets: Primary, Clinical and Select.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040758
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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