Identifiers
- 510(k) Number
- K930734 FDA 510(k)
- FDA Product Code
- LEG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3645 FDA 510(k)
- Regulation Number
- 862.3645 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CEDIA Valporic Acid Assay is an enzyme immunoassay (EIA) device used for the quantitative measurement and therapeutic monitoring of valproic acid in clinical specimens. This assay is designed to provide reliable performance for therapeutic drug monitoring purposes.
The assay is supplied as a collection of reagents and associated materials for use with various analyzers including Beckman Coulter AU400, AU640, AU480, AU680, AU2700, AU5400, and AU5800 models. It is a Class II medical device cleared by the FDA under 510(k) K930734 on September 21, 1993, for use in clinical toxicology applications.
Frequently asked questions
What is the CEDIA Valporic Acid Assay used for?
The CEDIA Valporic Acid Assay is an enzyme immunoassay (EIA) device used for the quantitative measurement and therapeutic monitoring of valproic acid in clinical specimens. It provides reliable performance for therapeutic drug monitoring purposes in clinical settings.
Which analyzers is the CEDIA Valporic Acid Assay compatible with?
The assay is supplied as a collection of reagents and associated materials for use with various Beckman Coulter analyzers including AU400, AU640, AU480, AU680, AU2700, AU5400, and AU5800 models. It is designed to integrate seamlessly with these specific analyzer platforms.
What is the regulatory status of the CEDIA Valporic Acid Assay?
The CEDIA Valporic Acid Assay is a Class II medical device cleared by the FDA under 510(k) K930734 on September 21, 1993. It was cleared for use in clinical toxicology applications and is manufactured by Microgenics Corporation.
How is the CEDIA Valporic Acid Assay supplied?
The assay is supplied as a collection of reagents and associated materials specifically designed for use with compatible Beckman Coulter analyzers. The complete kit includes all necessary components for performing the quantitative measurement of valporic acid in clinical specimens.
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: PDF CEDIA Valporic Acid Beckman Coulter AU400,AU640,AU480,AU680, AU2700 ..., CEDIA VALPORIC ACID ASSAY (K930734) — FDA 510(k) | Innolitics, CEDIA™ Therapeutic Drug Monitoring (TDM) Assays, DEVICE: CEDIA Valproic Acid II Assay (00884883001305), PDF CEDIATM Valproic Acid II Assay - Fisher Sci
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K930734 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K930734 24 fields · synced Sep 28, 2026