510(k) · Cleared
ClearedThermo Scientific Cedia Cannabinoids Oft Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Apr 8, 2011 as substantially equivalent to K002375 (OraSure Technologies, Inc., 2001) after a 290-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Apr 8, 2011
- Review
- 290 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002375 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK002375 STC Cannabinoids Intercept Micro-Plate Eia, Model 1118IOraSure Technologies, Inc. · 2001 · Recalled
- This deviceK101744 Thermo Scientific Cedia Cannabinoids Oft AssayMicrogenics Corp. · 2011
- Descendant · cites it directly · 0 of its ownK132096 Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control…Biophor Diagnostics, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132096Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, CollectorBiophor Diagnostics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002375 | STC Cannabinoids Intercept Micro-Plate Eia, Model 1118I | OraSure Technologies, Inc. | 2001 | 4 |
| 0 (this device) | K101744 | Thermo Scientific Cedia Cannabinoids Oft Assay | Microgenics Corp. | 2011 | — |
| +1 | K132096 | Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set… | Biophor Diagnostics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 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 |
|---|---|---|---|
| * | K002375 | STC Cannabinoids Intercept Micro-Plate Eia, Model 1118ISummary page 2…d device to which equivalency is claimed CEDIA® Cannabinoids OFT Assay is substantially equivalent to the previously cleared STO Cannabinoids Intercept® MICRO-PLATE EIA, K002375 (At present OTI, OraSure Technologies Inc.) DESCRIPTION OF DEVICE CEDIA® Cannabinoids OFT Assay Microgenics CEDIA Cannabinoids OF… | 2001 |
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 |
|---|---|---|---|
| K132096 | Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, Collector | 2013 | 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 LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids in human oral fluid at a cutoff concentration of 3 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 I-A9 THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA THO OFT Calibrators are…
Read the full statement (166 words)
The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids in human oral fluid at a cutoff concentration of 3 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 I-A9 THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA THO OFT Calibrators are intended for use in the calibration of I-A9 THC when used with the CEDIA Cannabinoids OFT Assay. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cannabinoids 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/K101744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101744: Thermo Scientific Cedia Cannabinoids Oft Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101744
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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