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DRI Ecstasy Plus Assay

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240670

by Microgenics Corporation

Identifiers

510(k) Number
K240670 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 DRI Ecstasy Plus Assay is an enzyme immunoassay (product code DKZ) designed for the qualitative detection of amphetamine-type compounds, including ecstasy, in urine samples. It employs a competitive assay format using antibodies to distinguish target drugs with minimal cross-reactivity to other amphetamines, enabling rapid screening in clinical toxicology settings.

This device is supplied as a ready-to-use liquid reagent kit and requires no additional preparation beyond standard immunoassay procedures. It is intended for single-use in laboratory settings and has received FDA 510(k) clearance under Special Controls for Class II devices, alongside IVDD authorization. Storage conditions and regulatory compliance are specified in the manufacturer’s instructions, ensuring proper handling and validation for clinical use.

Frequently asked questions

What clinical setting is the DRI Ecstasy Plus Assay primarily intended for, and how does it function in that context?

The DRI Ecstasy Plus Assay is designed for clinical toxicology settings, where rapid and accurate detection of amphetamine-type compounds—including ecstasy—in urine samples is critical. It uses a competitive enzyme immunoassay (EIA) format, leveraging antibodies to specifically identify target drugs with minimal cross-reactivity to other amphetamines. This makes it ideal for screening patients suspected of exposure, supporting timely clinical decision-making in emergency or forensic toxicology workflows.

How is the DRI Ecstasy Plus Assay supplied, and what preparation is required before use?

The assay is supplied as a ready-to-use liquid reagent kit, eliminating the need for additional preparation beyond standard immunoassay procedures. This means no reconstitution, dilution, or assembly is required—just follow the manufacturer’s instructions for immediate use in laboratory settings. The convenience reduces handling time and potential for contamination.

Is the DRI Ecstasy Plus Assay intended for single-use or repeated testing, and what are the implications for cost and workflow?

The device is explicitly intended for single-use only, which aligns with standard practices for immunoassays to ensure accuracy and prevent cross-contamination. This design implies each kit is dedicated to one test, which may impact bulk purchasing costs but simplifies inventory management and reduces the risk of carryover errors in high-throughput clinical or forensic toxicology labs.

What regulatory pathways has the DRI Ecstasy Plus Assay undergone, and how does this affect its clinical adoption?

The assay has received FDA 510(k) clearance under Special Controls for Class II devices, alongside In Vitro Diagnostic Device Directive (IVDD) authorization. These pathways confirm its compliance with U.S. and EU regulatory standards for diagnostic accuracy and safety, enabling adoption in clinical toxicology settings where validated, cleared assays are required. The clearance also reflects its equivalence to predicate devices, supporting its reliability for detecting amphetamine-type compounds.

Are there specific storage requirements for the DRI Ecstasy Plus Assay, and how might they affect its usability in different lab environments?

While the exact storage conditions aren’t detailed in the provided data, the manufacturer’s instructions (referenced in the description) would outline requirements like temperature, humidity, and light exposure to maintain assay integrity. For clinical toxicology labs, this likely means refrigeration or room-temperature storage with protective packaging, ensuring stability until use. Adherence to these guidelines is critical to preserve sensitivity and specificity, particularly in environments with fluctuating conditions.

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: PDF DRI Ecstasy Plus Assay - documents.thermofisher.com, DRI Ecstasy Plus Assay Clearance | Medical Device Navigator, K240670 FDA 510 (k) - DRI Ecstasy Plus Assay

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Microgenics Corporation

Sources (2)

  • FDA 510(k) K240670 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 19, 2026