MSW · Class II · 21 CFR 866.6010

FDA Product Code MSW: System, Test, Thyroglobulin

Thyroglobulin monitoring is essential in the follow-up of differentiated thyroid cancer after thyroidectomy. FDA product code MSW covers thyroglobulin test systems.

These immunoassays measure thyroglobulin — a protein produced exclusively by thyroid follicular cells — as a tumor marker to detect residual or recurrent thyroid cancer in patients following thyroid surgery and radioiodine ablation.

MSW devices are Class II medical devices, regulated under 21 CFR 866.6010 and reviewed by the FDA Immunology panel.

Leading manufacturers include Beckman Coulter, Inc., Roche Diagnostics and Siemens Healthcare Diagnostics, Inc..

5
Total
5
Cleared
271d
Avg days
2023
Since

List of System, Test, Thyroglobulin devices cleared through 510(k)

5 devices
1–5 of 5
Cleared Jun 20, 2025
Atellica IM Thyroglobulin (Tg)
K242981
Siemens Healthcare Diagnostics, Inc.
Immunology · 267d
Cleared Jun 28, 2024
Access Thyroglobulin
K240927
Beckman Coulter, Inc.
Immunology · 85d
Cleared Jun 07, 2024
Access Thyroglobulin
K241423
Beckman Coulter, Inc.
Immunology · 18d
Cleared Sep 30, 2023
Elecsys Tg II
K221890
Roche Diagnostics
Immunology · 458d
Cleared Sep 15, 2023
Access Thyroglobulin
K220972
Beckman Coulter, Inc.
Immunology · 529d

How to use this database

This page lists all FDA 510(k) submissions for System, Test, Thyroglobulin devices (product code MSW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Immunology FDA review panel. Browse all Immunology devices →