Thermo Scientific CEDIA Cocaine OFT Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101742 FDA 510(k)
- FDA Product Code
- DIO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3250 FDA 510(k)
- Regulation Number
- 862.3250 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Thermo Scientific CEDIA Cocaine OFT Assay is an enzyme immunoassay designed for the qualitative detection of cocaine and its metabolites in human oral fluid samples. It employs a competitive binding assay to identify benzoylecgonine at specified cutoff concentrations, aiding in drug screening applications within clinical toxicology.
This assay is supplied as a ready-to-use kit for in vitro diagnostic use, intended for single-use only. It is regulated under the In Vitro Diagnostic Device Directive (IVDD) and holds FDA 510(k) clearance as a Class II device. The assay requires oral fluid samples collected via the Thermo Scientific Oral Fluid Device, with cutoff values of 5 ng/mL for diluted samples and 15 ng/mL for neat samples. Storage and handling follow standard IVD protocols to maintain assay integrity.
Frequently asked questions
What types of samples does the Thermo Scientific CEDIA Cocaine OFT Assay use, and how are they collected?
This assay is designed specifically for human oral fluid samples, collected using the Thermo Scientific Oral Fluid Device. The device ensures proper sample collection for accurate testing of cocaine and its metabolites via a competitive enzyme immunoassay.
Is this assay intended for single-use or reusable applications, and what does that mean for workflow?
The Thermo Scientific CEDIA Cocaine OFT Assay is supplied as a single-use kit, meaning each test requires a new assay kit. This design ensures consistency and reliability in results while minimizing cross-contamination risks in clinical or forensic settings.
What cutoff concentrations does the assay detect for cocaine metabolites, and how does dilution affect sensitivity?
The assay detects benzoylecgonine, a cocaine metabolite, at cutoff concentrations of 15 ng/mL for neat oral fluid samples and 5 ng/mL for diluted samples. Dilution lowers the threshold, improving sensitivity for lower-concentration samples while maintaining accuracy.
How should the assay be stored to maintain its integrity, and are there any special handling requirements?
Storage follows standard in vitro diagnostic (IVD) protocols to preserve assay integrity. The kit should be stored according to manufacturer instructions (typically refrigerated or at room temperature, as specified in the accompanying documentation) to prevent degradation and ensure reliable performance.
What regulatory pathways does this device follow, and how does that impact its use in clinical toxicology?
The Thermo Scientific CEDIA Cocaine OFT Assay is regulated under the In Vitro Diagnostic Device Directive (IVDD) and holds FDA 510(k) clearance as a Class II device, classified under Clinical Toxicology. This means it undergoes rigorous validation for safety and performance before use in drug screening applications.
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 Cocaine OFT Assay Application Beckman Coulter AU680, DE - Thermo Fisher Scientific, PDF CEDIA Cocaine OFT Assay Application (UK) Beckman Coulter AU680, Thermo Scientific - Fisher Sci
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 | K101742 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K101742 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026