CEDIA DAU Benzodiazepine Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K951710 FDA 510(k)
- FDA Product Code
- JXM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3170 FDA 510(k)
- Regulation Number
- 862.3170 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CEDIA DAU Benzodiazepine Assay is an enzyme immunoassay for the detection of benzodiazepines in clinical specimens. It is classified as a Class II medical device under regulation number 862.3170 and is intended for use in clinical toxicology settings.
The assay was cleared via the FDA 510(k) pathway under K951710 with a traditional clearance decision, determined to be substantially equivalent to a predicate device. It is supplied by Microgenics Corporation and is intended for in vitro diagnostic use in laboratories performing toxicology testing.
Frequently asked questions
What is the CEDIA DAU Benzodiazepine Assay used for?
The CEDIA DAU Benzodiazepine Assay is an enzyme immunoassay designed for the detection of benzodiazepines in clinical specimens, intended for use in clinical toxicology settings to support laboratory testing for substance use monitoring.
How is the CEDIA DAU Benzodiazepine Assay supplied and for what type of use?
The assay is supplied by Microgenics Corporation and is intended for in vitro diagnostic use in laboratories performing toxicology testing, meaning it is used outside the body to analyze patient samples such as urine or serum for benzodiazepine presence.
What regulatory pathway was used to clear the CEDIA DAU Benzodiazepine Assay?
The assay was cleared via the FDA 510(k) pathway under submission number K951710 with a traditional clearance decision, determined to be substantially equivalent to a legally marketed predicate device, which allows it to be legally marketed in the United States for its intended 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951710 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K951710 24 fields · synced Sep 23, 2026