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CEDIA DAU Barbiturate Assay

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K936030

by Microgenics Corporation

Identifiers

510(k) Number
K936030 FDA 510(k)
FDA Product Code
DIS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3150 FDA 510(k)
Regulation Number
862.3150 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CEDIA DAU Barbiturate Assay is an enzyme immunoassay designed for the qualitative detection of barbiturates in biological specimens. It employs a chemiluminescent enzyme donor-acceptor immunoassay (CEDIA) technology to identify barbiturate presence, aiding in clinical toxicology assessments.

This device is intended for in vitro diagnostic use and is supplied as a single-use reagent kit. It is classified as a Class II medical device under FDA regulations (862.3150) and has received FDA 510(k) clearance (K936030) and IVDD authorization. The assay requires appropriate laboratory handling and storage as per manufacturer instructions to maintain accuracy and reliability.

Frequently asked questions

What is the CEDIA DAU Barbiturate Assay used for in a clinical setting?

The CEDIA DAU Barbiturate Assay is designed for the qualitative detection of barbiturates in biological specimens, such as blood or urine. It aids in clinical toxicology assessments by helping identify the presence of barbiturate drugs, which can be critical for diagnosing poisoning, overdose, or monitoring patients with suspected barbiturate exposure.

Is this assay single-use, or can it be reused after opening?

The CEDIA DAU Barbiturate Assay is supplied as a single-use reagent kit. Each kit is intended for one test procedure only, and reuse is not recommended or supported by the manufacturer to ensure accuracy and reliability.

What type of technology does this assay use, and how does it work?

This assay employs chemiluminescent enzyme donor-acceptor immunoassay (CEDIA) technology, which detects barbiturates through a biochemical reaction. The method relies on antibodies specific to barbiturates binding to the target analyte in the sample, triggering a chemiluminescent signal that indicates the presence of the drug.

How should the assay be stored to maintain its effectiveness?

The assay requires appropriate laboratory handling and storage as per the manufacturer’s instructions to preserve accuracy and reliability. While exact storage conditions (e.g., temperature, humidity) are not detailed here, typical enzyme immunoassays like this one are generally stored refrigerated or at room temperature, away from direct light, until use.

What regulatory pathways has this device undergone, and what does that mean for its use?

The CEDIA DAU Barbiturate Assay has undergone FDA 510(k) clearance (K936030) and In Vitro Diagnostic Device (IVDD) authorization, confirming it meets U.S. regulatory standards for Class II medical devices. This classification and clearance indicate it has been evaluated for safety and performance in clinical toxicology applications, though it does not imply any specific clinical indication beyond its labeled use.

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 BARBITURATE ASSAY (K942436) — FDA 510(k) | Innolitics, CEDIA DAU BARBITURATE ASSAY (K936030) - FDA 510 (k), Cedia (R) Dau Barbiturate Assay, Modification, PDF K942436 - Cedia Dau Barbiturate Assay, 510(k) Premarket Notification

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) K936030 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026