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Microzyme T4 Enzyme Immunoassay Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K902922

by Immunotech Corp.

Identifiers

510(k) Number
K902922 FDA 510(k)
FDA Product Code
CDX 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 Microzyme T4 Enzyme Immunoassay Kit is a radioimmunoassay device for measuring total thyroxine (T4) in serum or plasma. It employs enzyme-linked immunoassay technology to quantify thyroid hormone levels, aiding in the diagnosis and monitoring of thyroid disorders such as hypothyroidism, hyperthyroidism, and thyroid dysfunction. The assay is designed to provide accurate and reproducible results for clinical chemistry applications, supporting endocrinological assessments.

This kit is supplied as a single-use diagnostic reagent intended for in vitro use in clinical laboratories. It requires no special storage conditions beyond refrigeration (2–8°C) and is compatible with standard laboratory equipment. The device is classified under FDA product code CDX and was granted FDA 510(k) clearance (K902922) in 1990 under the Clinical Chemistry advisory committee. No MRI safety or reusable components are specified, and regulatory compliance is tied to the original submission data.

Frequently asked questions

What is the Microzyme T4 Enzyme Immunoassay Kit used for?

The Microzyme T4 Enzyme Immunoassay Kit is designed for measuring total thyroxine (T4) levels in serum or plasma using enzyme-linked immunoassay technology. It supports the diagnosis and monitoring of thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroid dysfunction, by providing precise and reproducible results for clinical chemistry applications.

How is the Microzyme T4 Enzyme Immunoassay Kit supplied and stored?

The kit is supplied as a single-use diagnostic reagent intended exclusively for in vitro use in clinical laboratories. It requires standard refrigeration (2–8°C) for storage and does not need any additional preservation measures beyond this temperature range.

Is the Microzyme T4 Enzyme Immunoassay Kit reusable or single-use?

This kit is explicitly intended for single-use only. It is not designed or approved for reuse, ensuring accuracy and sterility for each diagnostic procedure.

What regulatory pathway does the Microzyme T4 Enzyme Immunoassay Kit follow?

The kit was granted FDA 510(k) clearance (K902922) in 1990 under the Clinical Chemistry advisory committee. It is classified under FDA product code CDX and is considered substantially equivalent to prior devices, with compliance tied to the original submission data.

What types of samples can the Microzyme T4 Enzyme Immunoassay Kit analyze?

The kit is specifically designed to measure total thyroxine (T4) in serum or plasma samples. It is not intended for use with other bodily fluids or alternative sample types.

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: K902922 - MICROZYME T4 ENZYME IMMUNOASSAY KIT | FDA 510 (k), PDF K902922 - Microzyme T4 Enzyme Immunoassay Kit, Microzyme (Tm) Free T4 Enzyme Immunoassay Test, Microzyme (Tm) Free T4 Enzyme Immunoassay Test, Microzyme T4 Enzyme Immunoassay Kit - 药智医械数据

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immunotech Corp.

Sources (1)

  • FDA 510(k) K902922 24 fields · synced Oct 1, 2026