Thermo Scientific CEDIA Cannabinoids OFT Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101744 FDA 510(k)
- FDA Product Code
- LDJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3870 FDA 510(k)
- Regulation Number
- 862.3870 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Thermo Scientific CEDIA Cannabinoids OFT Assay is an enzyme immunoassay designed for the qualitative and semiquantitative detection of cannabinoids in human oral fluid. It employs competitive binding principles to measure cannabinoid levels at specified cutoff concentrations, aiding in clinical toxicology assessments.
This assay is supplied as a single-use reagent kit for in vitro diagnostic use, requiring collection of oral fluid exclusively via the Oral-Eze® Oral Fluid Collection System. It is classified as a Class II device under FDA regulations and meets In Vitro Diagnostic Device Directive (IVDD) standards. The assay is intended for use with specified analyzers, such as the Beckman Coulter AU680 or AU2700, and is regulated under the FDA’s 510(k) clearance and the EU’s IVDD framework.
Frequently asked questions
What clinical scenarios is this assay primarily used for and how does it help in those settings?
The Thermo Scientific CEDIA Cannabinoids OFT Assay is designed for clinical toxicology assessments, specifically to qualitatively and semiquantitatively detect cannabinoids in human oral fluid. It aids in identifying recent cannabis exposure by measuring cannabinoid levels at specified cutoff concentrations, which is particularly useful in emergency departments, forensic toxicology, or workplace drug testing programs where oral fluid collection is preferred over blood or urine.
Is this assay compatible with any specific oral fluid collection devices, and why does that matter?
Yes, this assay is exclusively intended for use with the Oral-Eze® Oral Fluid Collection System. This matters because the assay’s performance—including sensitivity and accuracy—is validated for oral fluid collected via this specific device. Using alternative collection methods could compromise test reliability, as the assay’s calibration and cutoff concentrations are tailored to Oral-Eze®-collected samples.
How is the assay supplied, and what does ‘single-use reagent kit’ imply for workflow and cost management?
The assay is supplied as a single-use reagent kit, meaning each kit contains all necessary components for one test run. This design eliminates the need for reprocessing or sterilization between uses, reducing contamination risks and simplifying workflow. However, it may impact cost management in high-throughput settings, as each test requires a new kit, though it ensures consistent performance and compliance with in vitro diagnostic standards.
Which analyzers are compatible with this assay, and what should I consider when selecting one?
The assay is designed for use with Beckman Coulter AU680 or AU2700 analyzers, as these platforms are validated for its automated processing. When selecting an analyzer, ensure it meets the assay’s technical requirements (e.g., optical detection capabilities) and that your lab’s workflow aligns with the analyzer’s throughput and maintenance needs. Compatibility with these specific models ensures accurate results and adherence to the assay’s performance specifications.
What regulatory pathways does this device follow, and how does that affect procurement or adoption?
The assay is cleared under the FDA’s 510(k) pathway (K101744) as a Class II device, indicating it meets substantial equivalence to a predicate device and is subject to general controls plus special controls for enzyme immunoassays. It also complies with the EU’s In Vitro Diagnostic Device Directive (IVDD), meaning it is suitable for markets requiring CE marking. Procurement teams should verify local regulatory requirements and ensure the device’s compliance aligns with their institution’s or country’s in vitro diagnostic standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Thermo Fisher Scientific - DE, PDF CEDIA Cannabinoids OFT Assay Application (EU) Beckman Coulter AU680, AU2700, DE - Thermo Fisher Scientific, Thermo Scientific - Fisher Sci, Thermo Scientific Cedia Cannabinoids Oft Assay
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101744 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K101744 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026