Identifiers
- 510(k) Number
- K942575 FDA 510(k)
- FDA Product Code
- KLI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1700 FDA 510(k)
- Regulation Number
- 862.1700 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CEDIA T4 MAB Assay is an enzyme immunoassay for measuring total thyroxine (T4) levels in serum or plasma. It employs a chemiluminescent enzyme donor-immobilized assay (CEDIA) technique to detect and quantify T4 concentrations, providing a non-radiolabeled diagnostic solution for clinical chemistry applications.
This assay is intended for in vitro diagnostic use and is supplied as a reagent kit for laboratory testing. It is classified as a Class II device under FDA regulations (862.1700) and has received FDA 510(k) clearance and IVDD authorization. The device is designed for single-use and requires proper storage under controlled conditions to maintain accuracy and reliability.
Frequently asked questions
What is the CEDIA T4 MAB Assay used for in a clinical setting?
The CEDIA T4 MAB Assay is an enzyme immunoassay designed to measure total thyroxine (T4) levels in serum or plasma samples. It uses a chemiluminescent enzyme donor-immobilized technique (CEDIA) to provide accurate, non-radiolabeled quantification of T4, supporting clinical chemistry testing for thyroid function evaluation.
Is this assay single-use or reusable, and how should it be stored?
The CEDIA T4 MAB Assay is intended for single-use only to ensure accuracy and reliability. It must be stored under controlled conditions as specified in the kit instructions to maintain its performance. Proper storage is critical for preserving the assay’s integrity before use.
What regulatory pathways has this device undergone, and what does that mean for its use?
The CEDIA T4 MAB Assay has received FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization, confirming it meets U.S. regulatory standards for Class II devices (under FDA classification 862.1700). This means it has been evaluated for safety, performance, and equivalence to predicate devices, ensuring its suitability for clinical chemistry applications as intended.
How is the assay supplied, and what type of laboratory testing does it support?
The CEDIA T4 MAB Assay is supplied as a reagent kit for in vitro diagnostic use in laboratory settings. It is designed for serum or plasma samples and supports quantitative measurement of total thyroxine (T4) levels, aiding in thyroid function diagnostics without requiring radioactive labeling.
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
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K942575 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K942575 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026