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CEDIA T4 MAB Assay Modification

FDA 510(k)

Class II (US FDA 510(k))

510(k) K935880

by Microgenics Corporation

Identifiers

510(k) Number
K935880 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 Modification is an enzyme immunoassay designed for the quantitative measurement of total thyroxine (T4) in serum or plasma. As a non-radiolabeled assay, it employs chemiluminescent enzyme immunoassay technology (CEDIA) to detect and quantify T4 levels, aiding in the diagnosis and monitoring of thyroid function disorders.

This device is intended for in vitro diagnostic use in clinical chemistry laboratories. Supplied as a single-use reagent kit, it requires no special storage conditions beyond refrigeration and is compatible with standard laboratory equipment. The assay received FDA 510(k) clearance under classification KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine) and is regulated under FDA regulation 862.1700, falling under Class II medical devices. No third-party review was involved in its clearance.

Frequently asked questions

What is the CEDIA T4 MAB Assay Modification used for in a clinical setting?

The CEDIA T4 MAB Assay Modification is designed for the quantitative measurement of total thyroxine (T4) in serum or plasma samples. It uses chemiluminescent enzyme immunoassay technology to help diagnose and monitor thyroid function disorders, such as hypothyroidism or hyperthyroidism, by providing accurate T4 level readings in clinical chemistry laboratories.

Is this assay single-use, and how should it be stored?

Yes, the CEDIA T4 MAB Assay Modification is supplied as a single-use reagent kit. Storage is straightforward—it only requires refrigeration, so no special conditions are needed beyond keeping it cool and dry until use.

What regulatory pathway did this device follow to gain clearance, and what class is it under?

The CEDIA T4 MAB Assay Modification received FDA 510(k) clearance through a traditional review process, determined to be *substantially equivalent* to a predicate device. It is classified as a Class II medical device under FDA regulation 862.1700, specifically under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine).

Does this assay require any specialized laboratory equipment, or is it compatible with standard lab setups?

The CEDIA T4 MAB Assay Modification is fully compatible with standard clinical chemistry laboratory equipment. No additional specialized tools are required beyond typical immunoassay instrumentation, making it easy to integrate into existing workflows.

How was the FDA’s decision on this assay documented, and was there any third-party involvement?

The FDA’s decision was documented as *substantially equivalent* (SESE) under the 510(k) process, with a clearance date of March 3, 1994. The review was conducted by the Clinical Chemistry (CH) advisory committee, and no third-party review was involved in the clearance process.

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 T4 MAB ASSAY MODIFICATION (K935880) - FDA 510 (k), CEDIA T4 MAB ASSAY MODIFICATION (K935880) - Innolitics, CEDIA T4 MAB ASSAY MODIFICATION 510 (k) K935880 - FDA.report, K942575 FDA 510(k) - CEDIA T4 MAB ASSAY | Microgenics Corp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Microgenics Corporation
FDA Applicant
Microgenics Corp.

Sources (1)

  • FDA 510(k) K935880 24 fields · synced Sep 19, 2026