510(k) · Cleared
ClearedThermo Scientific Cedia Cocaine Oft Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Apr 8, 2011 as substantially equivalent to K001197 (OraSure Technologies, Inc., 2000) after a 290-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Apr 8, 2011
- Review
- 290 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001197 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK001197 Cocaine Metabolite Intercept Micro-Plate EiaOraSure Technologies, Inc. · 2000
- This deviceK101742 Thermo Scientific Cedia Cocaine Oft AssayMicrogenics Corp. · 2011
- Descendant · cites it directly · 0 of its ownK142129 Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine…Biophor Diagnostics, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142129Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set…Biophor Diagnostics, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001197 | Cocaine Metabolite Intercept Micro-Plate Eia | OraSure Technologies, Inc. | 2000 | — |
| 0 (this device) | K101742 | Thermo Scientific Cedia Cocaine Oft Assay | Microgenics Corp. | 2011 | — |
| +1 | K142129 | Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine… | Biophor Diagnostics, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 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 |
|---|---|---|---|
| * | K001197 | Cocaine Metabolite Intercept Micro-Plate EiaSummary page 2…age 2 === Comparison of Technological Characteristics The CEDIA Cocaine OFT Assay is substantially equivalent to the OTI Cocaine Metabolite Intercept® MICRO-PLATE EIA. (K001 197) Predicate Device Coprsn Subject Device.… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142129 | Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set… | 2015 | 0 |
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?
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CEDIA® Cocaine OFT Assay is intended for use in the qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 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 benzoylecgonine and performed on the MGC24O. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Cocaine OFT Assay provides only…
Read the full statement (129 words)
The CEDIA® Cocaine OFT Assay is intended for use in the qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 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 benzoylecgonine and performed on the MGC24O. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cocaine 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 particularl when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101742: Thermo Scientific Cedia Cocaine 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/K101742
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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