Cedia Dau Amphetamines/Ecstasy Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K010496 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 CEDIA DAU Amphetamines/MDMA Assay is a chemiluminescent enzyme immunoassay designed for the qualitative detection of amphetamines and 3,4-methylenedioxymethamphetamine (MDMA, or ecstasy) in urine specimens. It employs a competitive assay principle to identify these substances, providing a rapid screening method for clinical toxicology applications.
This assay is supplied as a ready-to-use diagnostic kit, intended for single-use in clinical laboratory settings. It requires no additional processing beyond standard urine sample preparation and is classified as a Class II device under FDA regulations. The kit includes all necessary reagents and components for performing the assay, with results determined via chemiluminescent detection. Authorisations include FDA 510(k) clearance and compliance with the In Vitro Diagnostic Medical Device Directive (IVDD)
Frequently asked questions
What is the CEDIA DAU Amphetamines/MDMA Assay used for in clinical settings?
The CEDIA DAU Amphetamines/MDMA Assay is designed for the qualitative detection of amphetamines and MDMA (ecstasy) in urine specimens, serving as a rapid screening tool in clinical toxicology. It helps identify the presence of these substances without requiring complex sample preparation beyond standard urine handling.
Is this assay intended for single-use or repeated use in a clinical lab?
The CEDIA DAU Amphetamines/MDMA Assay is explicitly supplied as a ready-to-use diagnostic kit for single-use only. Each kit contains all necessary reagents and components, ensuring no cross-contamination or reuse risks in clinical laboratory settings.
How is the test result determined, and what technology does it use?
The assay employs a chemiluminescent enzyme immunoassay (CEDIA DAU) with a competitive binding principle. Results are generated through chemiluminescent detection, providing a measurable signal to indicate the presence or absence of amphetamines/MDMA in the urine sample.
What regulatory pathways has this device undergone, and what does that mean for its use?
The CEDIA DAU Amphetamines/MDMA Assay holds FDA 510(k) clearance and complies with the In Vitro Diagnostic Medical Device Directive (IVDD), confirming its classification as a Class II device. This means it has undergone rigorous review for safety and performance, ensuring reliability for clinical toxicology screening.
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.
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 | K010496 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K010496 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026