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RADIAS Free T4 Enzyme Immunoassay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K931110

by Bio-Rad

Identifiers

510(k) Number
K931110 FDA 510(k)
FDA Product Code
CEC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1695 FDA 510(k)
Regulation Number
862.1695 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The RADIAS Free T4 Enzyme Immunoassay is an enzyme-linked immunoassay designed for the quantitative measurement of free thyroxine (T4) in serum or plasma. It employs a competitive binding technique using a radiolabeled antibody to detect and quantify unbound (free) thyroxine 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 kit, it requires no sterilization beyond manufacturer-provided packaging. The assay is classified under FDA Product Code CEC (Radioimmunoassay, Free Thyroxine) and holds a Traditional 510(k) clearance (K931110) with a decision date of May 20, 1993. No MRI safety information or reusable components are specified in the data.

Frequently asked questions

What is the RADIAS Free T4 Enzyme Immunoassay used for in a clinical setting?

The RADIAS Free T4 Enzyme Immunoassay is designed for the quantitative measurement of free thyroxine (T4) in serum or plasma samples. It uses a competitive binding technique with a radiolabeled antibody to detect unbound (free) T4 levels, helping clinicians diagnose and monitor thyroid function disorders such as hyperthyroidism or hypothyroidism.

Is this assay single-use, and does it require any special handling beyond its packaging?

Yes, the RADIAS Free T4 Enzyme Immunoassay is supplied as a single-use kit, meaning each kit is intended for one-time use only. No additional sterilization is required beyond the manufacturer-provided packaging, as it is designed for in vitro diagnostic use in clinical chemistry laboratories.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

The RADIAS Free T4 Enzyme Immunoassay received a Traditional 510(k) clearance (K931110) under the FDA’s product code CEC (Radioimmunoassay, Free Thyroxine). This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in measuring free T4 levels in serum or plasma.

Are there any specific storage instructions or considerations for this assay kit?

While the provided data does not explicitly detail storage conditions, the RADIAS Free T4 Enzyme Immunoassay is supplied as a single-use kit with no mention of reusable components or special sterilization requirements. Standard laboratory practices for in vitro diagnostic assays—such as protecting from extreme temperatures, light, or contamination—should be followed to ensure accuracy and reliability of results.

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: RADIAS FREE T4 ENZYME IMMUNOASSAY - Innolitics, PDF K931110 - Radias Free T4 Enzyme Immunoassay, K925913 FDA 510 (k) - ACCESS FREE T4 ASSAY, Autoimmune Disease Panel — Bio-Rad, FDA Product Code CEC - Radioimmunoassay, Free Thyroxine | 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K931110 24 fields · synced Sep 19, 2026