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Thermo Scientific CEDIA Methamphetamine OFT Assay

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K101753

by Microgenics Corporation

Identifiers

510(k) Number
K101753 FDA 510(k)
FDA Product Code
LAF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3610 FDA 510(k)
Regulation Number
862.3610 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Thermo Scientific CEDIA Methamphetamine OFT Assay is a qualitative immunoassay designed for the detection of methamphetamine in human oral fluid. It employs enzyme-linked fluorescence technology to identify methamphetamine concentrations at or above a cutoff of 120 ng/mL in neat oral fluid samples, aiding in clinical toxicology assessments.

This assay is supplied as a ready-to-use reagent kit and is intended for single-use in laboratory settings. It requires collection of oral fluid exclusively via the Oral-Eze® Oral Fluid Collection System and is regulated under FDA 510(k) clearance and the In Vitro Diagnostic Medical Device Directive (IVDD). The device is classified as Class II and adheres to regulatory requirements outlined in 862.3610.

Frequently asked questions

What is the primary use of the Thermo Scientific CEDIA Methamphetamine OFT Assay in clinical settings?

The Thermo Scientific CEDIA Methamphetamine OFT Assay is designed specifically for qualitative detection of methamphetamine in human oral fluid, helping clinicians assess potential methamphetamine exposure or intoxication in toxicology evaluations. It uses enzyme-linked fluorescence technology to identify concentrations at or above 120 ng/mL, aiding in clinical decision-making for patients.

How is the oral fluid sample collected for this assay, and is the collection device included?

The assay requires exclusive use of the Oral-Eze® Oral Fluid Collection System for sample collection—this device is not part of the assay kit itself but is a mandatory companion for proper sample acquisition. The kit is a ready-to-use reagent system, meaning no additional preparation is needed beyond collecting oral fluid via the specified collection method.

Is the Thermo Scientific CEDIA Methamphetamine OFT Assay intended for single-use or repeated testing?

The assay is strictly for single-use per kit. Each reagent kit is designed to perform one test on a single oral fluid sample, ensuring accuracy and preventing cross-contamination. This aligns with standard laboratory practices for immunoassays to maintain reliability.

What regulatory pathways does this device follow, and how does that affect its use?

The device is cleared via FDA 510(k) (K101753) and complies with the In Vitro Diagnostic Medical Device Directive (IVDD), classifying it as a Class II device under regulatory category 862.3610. This means it undergoes rigorous validation for clinical toxicology applications, ensuring its use is governed by established diagnostic standards for oral fluid testing.

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 Methamphetamine OFT Assay - Thermo Fisher Scientific, DE - Thermo Fisher Scientific, CEDIA™ Therapeutic Drug Monitoring (TDM) Assays

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Microgenics Corporation
FDA Applicant
Microgenics Corp.

Sources (2)

  • FDA 510(k) K101753 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026