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Thyretain TSI Reporter Bioassay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092229

by Diagnostic Hybrids, Inc.

Identifiers

510(k) Number
K092229 FDA 510(k)
FDA Product Code
JZO 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 Thyretain TSI Reporter Bioassay is a Thyroid Autoantibody Test System designed to detect thyroid-stimulating immunoglobulin (TSI) in human serum. It employs a genetically engineered bioassay using Chinese hamster ovary (CHO) cells expressing a chimeric human thyroid-stimulating hormone receptor (TSHR) linked to a luciferase reporter gene. This system measures TSI activity by assessing cyclic adenosine monophosphate (cAMP) production, enabling specific identification of Graves’ disease-related autoantibodies.

This in vitro diagnostic device is intended for laboratory use and requires a one-hour incubation at room temperature. Supplied as a single-use assay, it is regulated under FDA 510(k) clearance (K092229) and falls under Class II medical devices (21 CFR 866.5870). Storage and handling follow standard laboratory protocols for immunoassay reagents, with no MRI safety considerations. The device is distributed by Diagnostic Hybrids, Inc., Athens, OH.

Frequently asked questions

What is the Thyretain TSI Reporter Bioassay used for?

This device detects thyroid-stimulating immunoglobulin (TSI) autoantibodies linked to Graves’ disease. It uses a genetically engineered bioassay with CHO cells expressing a human TSH receptor fused to a luciferase reporter gene. By measuring cyclic AMP (cAMP) production, it specifically identifies TSI activity in human serum, aiding in diagnostic confirmation of Graves’ disease.

How is the Thyretain TSI Reporter Bioassay supplied and used?

The assay is supplied as a single-use kit for laboratory testing. It requires a one-hour incubation at room temperature to measure TSI activity via cAMP production. The system is designed for in vitro diagnostic use only, following standard immunoassay protocols for handling and storage.

Is the Thyretain TSI Reporter Bioassay sterile and reusable?

The device is supplied as a single-use assay, meaning each kit is intended for one test cycle only. Sterility is maintained through standard laboratory immunoassay protocols, and reuse is not recommended or supported by the manufacturer.

What storage conditions are required for the Thyretain TSI Reporter Bioassay?

Storage follows standard laboratory protocols for immunoassay reagents. The manufacturer advises adhering to typical conditions for sensitive biological assays, though specific temperature or humidity requirements are not detailed beyond room-temperature incubation during use.

Does the Thyretain TSI Reporter Bioassay have any regulatory approvals or classifications?

The device holds FDA 510(k) clearance (K092229) and is classified as a Class II medical device under 21 CFR 866.5870. It was determined substantially equivalent through the Traditional 510(k) review process by the FDA’s Immunology (IM) Advisory Committee.

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: THYRETAIN™ Thyroid BioAssays | QuidelOrtho, PDF ~(g3 Thyretain Tm TS1 Reporter BioAssay SECTION 05, 510(K) SUMMARY H B IO, THYRETAIN TM TSI REPORTER BIOASSAY (K092229) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diagnostic Hybrids, Inc.

Sources (1)

  • FDA 510(k) K092229 24 fields · synced Oct 1, 2026