510(k) · Cleared
ClearedThermo Scientific Cedia Amphetamine Oft Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Apr 8, 2011 as substantially equivalent to K051579 (Immunalysis Corporation, 2005) after a 290-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Apr 8, 2011
- Review
- 290 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051579 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK051579 Immunalysis Amphetamine Elisa for Oral FluidsImmunalysis Corporation · 2005
- This deviceK101745 Thermo Scientific Cedia Amphetamine Oft AssayMicrogenics Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051579 | Immunalysis Amphetamine Elisa for Oral Fluids | Immunalysis Corporation | 2005 | — |
| 0 (this device) | K101745 | Thermo Scientific Cedia Amphetamine Oft Assay | 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 DKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K051579 | Immunalysis Amphetamine Elisa for Oral FluidsSummary page 2…device to which equivalency is claimed CEDIA® Amphetamine OFT Assay is substantially equivalent to the previously cleared Immunalysis Amphetamine ELISA for Oral Fluids (K051 579). DESCRIPTION OF DEVICE Principle of the CEDIA® Amphetamine OFT Assay The CEDIA® Amphetamine OFT Assay uses recombinant DNA te… | 2005 |
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.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CEDIA® Amphetamine OFT Assay is intended for use in the qualitative determination of amphetamine in human oral fluid at a cutoff concentration of 150 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze TM Saliva Collection System. The assay is calibrated against d-amphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Amphetamine OFT Assay…
Read the full statement (130 words)
The CEDIA® Amphetamine OFT Assay is intended for use in the qualitative determination of amphetamine in human oral fluid at a cutoff concentration of 150 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze TM Saliva Collection System. The assay is calibrated against d-amphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Amphetamine OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101745: Thermo Scientific Cedia Amphetamine Oft Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101745
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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