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CEDIA Theophylline Assay/Modification

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K905521

by Microgenics Corporation

Identifiers

510(k) Number
K905521 FDA 510(k)
FDA Product Code
LER FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3880 FDA 510(k)
Regulation Number
862.3880 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CEDIA Theophylline Assay/Modification is a Fluorescent Immunoassay for theophylline, classified under the Clinical Toxicology medical specialty. It employs chemiluminescent enzyme immunoassay technology to quantitatively measure theophylline levels in biological samples, aiding in the monitoring of patients undergoing theophylline therapy.

This device is supplied as a single-use reagent kit and is intended for use in clinical laboratory settings. It is not sterile and requires proper storage as specified in the accompanying instructions. The assay is authorised under FDA 510K clearance (K905521) and meets the requirements of the In Vitro Diagnostic Device Directive (IVDD). Compliance with regulatory standards ensures accurate and reliable measurement of theophylline concentrations.

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) K905521 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026