510(k) · Cleared
ClearedCedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · DIF Drug Mixture Control Materials
Cleared on Jan 17, 1997 as substantially equivalent to K935062 (Medical Analysis Systems, Inc., 1994) and 1 other predicate after a 25-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jan 17, 1997
- Review
- 25 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935062 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK935062 Mas Liquid Urinalysis ControlMedical Analysis Systems, Inc. · 1994
- This deviceK965157 Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1Boehringer Mannheim Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935062 | Mas Liquid Urinalysis Control | Medical Analysis Systems, Inc. | 1994 | — |
| 0 (this device) | K965157 | Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1 | Boehringer Mannheim Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (2)
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 |
|---|---|---|---|
| * | K935062 | Mas Liquid Urinalysis ControlSummary page 1…s (unassayed) - The Boehsinger Mannheim modified Multi-Drug Control Set is substantially - eduivalent to the Medical Analysis Systems (MAS) Liquid Urinalysis Controls (K935062). The Boehringer Mannheim modified Specialty Control Set 1 is substantially equivalent to the Multi-Drug Control Set (K951135).… | 1994 |
| * | K951135 | Multi-Drug Control SetSummary page 1…s Systems (MAS) Liquid Urinalysis Controls (K935062). The Boehringer Mannheim modified Specialty Control Set 1 is substantially equivalent to the Multi-Drug Control Set (K951135). The Multi-Drug Control Set and the Specialty Control Set 1 are manufactured using human urine, multiple drugs of abuse, stabil… | 1995 |
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?
- None of the 2 ancestors has a recall.
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 modified Multi-Drug Control Set and the modified Specialty Control Set 1 are intended to be used as quality control material to monitor drugs of abuse assays.
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/K965157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965157: Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965157
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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