← Back to catalogue

CEDIA DAU Cocaine Assay

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K941310

by Microgenics Corporation

Identifiers

510(k) Number
K941310 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 CEDIA DAU Cocaine Assay is an enzyme immunoassay designed for the qualitative detection of cocaine and its metabolites in biological specimens. It employs a competitive assay format to identify cocaine and benzoylecgonine, a primary metabolite, enabling rapid screening in clinical toxicology applications.

This device is intended for in vitro use in clinical laboratories and has received FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization. Supplied as a single-use reagent kit, it requires no special storage conditions beyond refrigeration and is classified under product code DIO as a Class II device under special controls. The assay is not MRI-compatible and must be handled according to standard laboratory protocols for immunoassays.

Frequently asked questions

What clinical applications is the CEDIA DAU Cocaine Assay designed for?

The CEDIA DAU Cocaine Assay is specifically designed for qualitative detection of cocaine and its primary metabolite, benzoylecgonine, in biological specimens. It is intended for use in clinical toxicology screening within certified clinical laboratories, helping identify cocaine exposure in patients.

Is this assay single-use, or can it be reused across multiple tests?

The CEDIA DAU Cocaine Assay is supplied as a single-use reagent kit, meaning each kit is intended for one assay procedure. This design ensures accuracy and prevents cross-contamination, adhering to standard laboratory protocols for immunoassays.

What storage conditions are required for the CEDIA DAU Cocaine Assay?

The assay requires standard refrigeration (typically 2–8°C) for storage. No additional specialized conditions are needed, making it convenient for most clinical laboratory settings. Always follow the manufacturer’s instructions to maintain integrity.

How is the regulatory status of this device classified, and what does that mean for users?

The CEDIA DAU Cocaine Assay holds FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization, classifying it as a Class II device under special controls (product code DIO). This means it has undergone rigorous review for safety and performance in clinical toxicology applications, ensuring reliability for qualified laboratories.

Does this assay have any compatibility restrictions, such as MRI or other imaging environments?

The CEDIA DAU Cocaine Assay is not MRI-compatible, but this limitation applies only to its physical handling in magnetic resonance environments—not its use in clinical testing. It is designed exclusively for in vitro laboratory use and must be handled according to standard immunoassay protocols.

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: CEDIA DAU COCAINE ASSAY (K945345) - FDA 510 (k), CEDIA DAU COCAINE ASSAY (K945345) — FDA 510 (k) | Innolitics, K935904 - Cedia Dau Cocaine Assay Hitachi 717 And..., CEDIA DAU COCAINE ASSAY 510 (k) K945345 - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Microgenics Corporation
FDA Applicant
Microgenics Corp.

Sources (2)

  • FDA 510(k) K941310 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026