510(k) · Cleared
ClearedThermo Scientific Cedia Multi-Drug Oft Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DKB Calibrators, Drug Mixture
Cleared on Apr 8, 2011 as substantially equivalent to K980853 (Boehringer Mannheim Corp., 1998) after a 290-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Apr 8, 2011
- Review
- 290 days
- Class
- Class II
- Product code
- DKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980853 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980853 Cedia Dau Multi-Drug CalibratorsBoehringer Mannheim Corp. · 1998
- This deviceK101752 Thermo Scientific Cedia Multi-Drug Oft CalibratorsMicrogenics Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980853 | Cedia Dau Multi-Drug Calibrators | Boehringer Mannheim Corp. | 1998 | — |
| 0 (this device) | K101752 | Thermo Scientific Cedia Multi-Drug Oft Calibrators | Microgenics Corp. | 2011 | — |
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 |
|---|---|---|---|
| * | K980853 | Cedia Dau Multi-Drug CalibratorsSummary page 1…d device to which equivalency is claimed The CEDIA® Multi-Drug OFT Calibrators are substantially equivalent to the previously cleared CEDIA® DAU Multi-Drug Calibrators (K980853). Description of the device The CEDIA® Multi-Drug OFT Calibrators are liquid ready-to-use. They are prepared by spiking known q… | 1998 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K980853.
How does its category compare?
All DKB devicesDKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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® Multi-Drug OFT Calibrators are intended for use in the calibration of d-Amphetamine, Benzoylecgonine, Morphine and Phencyclidine (PCP) in human Oral Fluid when used with the CEDIA Amphetamine, Cocaine, Opiate, and Phencyclidline (PCP) OFT Assays on the MGC 240 analyzer. This in vitro diagnostic device is intended for clinical laboratory use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101752: Thermo Scientific Cedia Multi-Drug Oft Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101752
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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