Thermo Scientific CEDIA Amphetamine OFT Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101745 FDA 510(k)
- FDA Product Code
- DKZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3100 FDA 510(k)
- Regulation Number
- 862.3100 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Thermo Scientific CEDIA Amphetamine OFT Assay is an enzyme immunoassay designed for the qualitative detection of amphetamine in human oral fluid. It employs competitive enzyme-linked immunosorbent assay (ELISA) technology to identify amphetamine presence above specified cutoff concentrations, aiding in clinical toxicology assessments.
This assay is intended for use in clinical laboratory settings with the Oral-Eze Oral Fluid Collection System for specimen collection. Supplied as a single-use reagent kit, it requires no sterilization beyond manufacturer-provided packaging. The device is classified as Class II under FDA regulations and has received 510(k) clearance and IVDD authorization. Cutoff concentrations are 17 ng/mL for diluted oral fluid and 150 ng/mL for neat oral fluid, as specified in the device’s intended use.
Frequently asked questions
What clinical setting is this assay designed for and what specimen collection system must be used with it?
The Thermo Scientific CEDIA Amphetamine OFT Assay is specifically designed for use in clinical laboratory settings to aid in clinical toxicology assessments. It requires the Oral-Eze Oral Fluid Collection System for collecting oral fluid specimens, ensuring proper sample acquisition for accurate amphetamine detection.
Is this assay single-use, and if so, what does that mean for handling and storage?
Yes, the Thermo Scientific CEDIA Amphetamine OFT Assay is supplied as a single-use reagent kit. This means each kit is intended for one test only, reducing the risk of cross-contamination. Proper handling includes keeping the kit unopened until use and storing it according to manufacturer instructions—typically in a cool, dry place away from direct light—until ready for use.
What are the cutoff concentrations for detecting amphetamine in oral fluid, and how do they differ between diluted and neat samples?
The assay has two cutoff concentrations: 17 ng/mL for diluted oral fluid and 150 ng/mL for neat (undiluted) oral fluid. These thresholds determine the minimum detectable levels of amphetamine, allowing for qualitative detection above these values. The lower cutoff for diluted samples may improve sensitivity for trace amounts in clinical scenarios.
How is the assay supplied, and does it require any special sterilization or preparation before use?
The assay is supplied as a complete single-use reagent kit, fully packaged and ready for use. No additional sterilization is required beyond the manufacturer-provided packaging, as it is designed for one-time use in controlled laboratory environments. Simply follow the included instructions for preparation and testing.
What regulatory pathways has this device undergone, and what does that mean for its use in clinical toxicology?
The Thermo Scientific CEDIA Amphetamine OFT Assay has received FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization, confirming its compliance with U.S. and European regulatory standards. This classification as a Class II device under FDA regulations ensures it meets stringent performance and safety criteria for clinical toxicology applications, particularly for detecting amphetamine in oral fluid specimens.
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 Amphetamine OFT Assay Application (ANZ) Beckman Coulter AU680, DE - Thermo Fisher Scientific, PDF CEDIA Amphetamine OFT Assay - Thermo Fisher Scientific
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 | K101745 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K101745 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026