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Thyroglobulin IgG ELISA Test System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000363

by Zeus Scientific, Inc.

Identifiers

510(k) Number
K000363 FDA 510(k)
FDA Product Code
DDC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5870 FDA 510(k)
Regulation Number
866.5870 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Thyroglobulin IgG ELISA Test System is a thyroid autoantibody immunological test system. It consists of reagents used to measure thyroid autoantibodies, which are antibodies produced against the body's own tissues, using immunochemical techniques.

This device is used to aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease. It has received FDA 510(k) clearance and is classified as a class 2 medical device under regulation number 866.5870.

Frequently asked questions

What is the primary purpose of the Thyroglobulin IgG ELISA Test System?

This device is an immunological test system designed to measure thyroid autoantibodies. These are antibodies produced by the body against its own tissues, and the test is used to aid clinicians in the diagnosis of specific thyroid disorders, including Hashimoto's disease.

How is this device classified for regulatory purposes?

The Thyroglobulin IgG ELISA Test System is classified as a class 2 medical device under regulation number 866.5870. It has received FDA 510(k) clearance, confirming it is substantially equivalent to other legally marketed devices in the immunology specialty.

What methodology does this test system use?

The system utilizes immunochemical techniques to detect and measure the presence of thyroid autoantibodies. By using these specific reagents, the test allows for the identification of antibodies that are characteristic of certain thyroid-related autoimmune conditions.

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: Modification to Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test ..., Modification to Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test ..., PDF K000363 Modification to Zeus Scientific, Inc., Thyroglobulin Igg Elisa ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA 510(k) K000363 24 fields · synced Sep 22, 2026