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CEDIA DAU Opiate Assay

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K941195

by Microgenics Corporation

Identifiers

510(k) Number
K941195 FDA 510(k)
FDA Product Code
DJG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3650 FDA 510(k)
Regulation Number
862.3650 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CEDIA DAU Opiate Assay is an enzyme immunoassay designed for the qualitative detection of opiates in biological specimens. It employs a chromogenic enzyme immunoassay technique to identify opiate presence, leveraging a competitive binding assay format for accurate results.

This assay is intended for use in clinical toxicology settings, typically within laboratories equipped for immunoassay procedures. Supplied as a single-use reagent kit, it requires no special storage conditions beyond refrigeration and is not intended for reuse. The device carries FDA 510(k) and IVDD authorizations, adhering to regulatory standards for in vitro diagnostic devices under classification 2.

Frequently asked questions

What types of biological specimens can the CEDIA DAU Opiate Assay detect opiates in, and how is it used in clinical settings?

The CEDIA DAU Opiate Assay is designed for qualitative detection of opiates in biological specimens, though the exact specimen types (e.g., urine, blood, or serum) are not explicitly listed in the data. It employs a competitive enzyme immunoassay (CEDIA) technique, which is commonly used in clinical toxicology labs to identify the presence of opiates. The assay requires standard laboratory equipment for immunoassays, making it suitable for settings like hospital toxicology labs or reference labs where such testing is routine.

Is the CEDIA DAU Opiate Assay intended for single-use only, and if so, what are the storage requirements?

Yes, the CEDIA DAU Opiate Assay is supplied as a single-use reagent kit, meaning each kit is designed for one test procedure only. Storage requirements are straightforward: it does not require special conditions beyond standard refrigeration (typically 2–8°C) to maintain integrity until use. There is no indication it can be reused or reprocessed.

What regulatory pathways has the CEDIA DAU Opiate Assay followed, and how does this affect its use in clinical toxicology?

The assay holds FDA 510(k) clearance and In Vitro Diagnostic Device Directive (IVDD) authorization, confirming it meets regulatory standards for class 2 in vitro diagnostic devices under the classification for enzyme immunoassays. This means it has undergone premarket review to demonstrate substantial equivalence to a predicate device, ensuring its safety, performance, and clinical validity for use in clinical toxicology—particularly for screening or confirming opiate presence in patient samples.

Are there multiple models or sizes available for the CEDIA DAU Opiate Assay, or is it a single standardized kit?

The provided data does not specify multiple models or sizes for the CEDIA DAU Opiate Assay. It is described as a single-use reagent kit, implying a standardized format for testing. If variations exist (e.g., different test volumes or formats), they are not detailed in the available information, so buyers should confirm with the manufacturer if specific configurations are needed for their workflow.

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

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) K941195 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026