510(k) · Cleared
ClearedCedia Dau Multi-Drug Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · DKB Calibrators, Drug Mixture
Cleared on Apr 21, 1998 after a 47-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Apr 21, 1998
- Review
- 47 days
- Class
- Class II
- Product code
- DKB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK980853 Cedia Dau Multi-Drug CalibratorsBoehringer Mannheim Corp. · 1998
- 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 ownK101752 Thermo Scientific Cedia Multi-Drug Oft CalibratorsMicrogenics Corp. · 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
- K101752Thermo Scientific Cedia Multi-Drug Oft CalibratorsMicrogenics Corp. · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K980853 | Cedia Dau Multi-Drug Calibrators | Boehringer Mannheim Corp. | 1998 | — |
| +1 | K081378 | Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls | Thermo Fisher Scientific | 2009 | — |
| +1 | K101752 | Thermo Scientific Cedia Multi-Drug Oft Calibrators | Microgenics Corp. | 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 DKB? 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 |
|---|---|---|---|
| * | — | Methadone Metabolite Urine Calibrators Named without a submission number |
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?
- Of its descendants, K081378 (Thermo Fisher Scientific, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DKB devicesDKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DKB
Too few DKB 510(k)s in any year since 2007 to give a median.
Recalls per year · DKB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKB
1in 2017
MAUDE reports naming product code DKB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 2 | 1 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CEDIA® DAU Multi-Drug Calibrators are intended for the calibration of qualitative and semiquantitative CEDIA DAU Assays on automated clinical chemistry analyzers.
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/K980853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980853: Cedia Dau Multi-Drug Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980853
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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