510(k) · Cleared
ClearedMulti-Drug Control Set
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 Apr 13, 1995 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 13, 1995
- Review
- 31 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK951135 Multi-Drug Control SetMicrogenics Corp. · 1995
- Descendant · cites it directly · 3 of its ownK040758 MGC Dau Control Sets: Primary, Clinical and SelectMicrogenics Corp. · 2004
- Descendant · 2 generations on · 1 of its ownK081378 Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific · 2009
- Descendant · 2 generations on · 0 of its ownK103656 Thermo Scientific Mas R Doa TotalMicrogenics Corporation · 2011
- Descendant · 3 generations on · 0 of its ownK092048 One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
- Descendant · cites it directly · 0 of its ownK965157 Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1Boehringer Mannheim Corp. · 1997
Most influential descendants
Showing 5 of 5 · See all- K040758MGC Dau Control Sets: Primary, Clinical and SelectMicrogenics Corp. · 2004 · cites it directly3descendants
- K081378Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific · 2009 · 2 generations on1descendant
- K103656Thermo Scientific Mas R Doa TotalMicrogenics Corporation · 2011 · 2 generations on0descendants
- K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010 · 3 generations on0descendants
- K965157Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1Boehringer Mannheim Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951135 | Multi-Drug Control Set | Microgenics Corp. | 1995 | — |
| +1 | K040758 | MGC Dau Control Sets: Primary, Clinical and Select | Microgenics Corp. | 2004 | — |
| +2 | K081378 | Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls | Thermo Fisher Scientific | 2009 | — |
| +2 | K103656 | Thermo Scientific Mas R Doa Total | Microgenics Corporation | 2011 | — |
| +3 | K092048 | One Step Eddp (Methadone Metabolite) Test Strip | Biosite Incorporated | 2010 | — |
| +1 | K965157 | Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1 | Boehringer Mannheim Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K040758 (Microgenics Corp., 2004) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K951135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951135: Multi-Drug Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951135
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026