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., Diagnostic Products Corp. and Roche Diagnostics.
13
Total
13
Cleared
178d
Avg days
1999
Since
Declining activity -
1 submissions in the last 2 years
vs 4 in the prior period
Review times increasing: avg
267d
recently vs 171d historically
FDA 510(k) Cleared System, Test, Thyroglobulin Devices (Product Code MSW)
13 devices
Cleared
Jun 20, 2025
Atellica IM Thyroglobulin (Tg)
Siemens Healthcare Diagnostics, Inc.
Immunology
267d
Cleared
Jun 28, 2024
Access Thyroglobulin
Beckman Coulter, Inc.
Immunology
85d
Cleared
Jun 07, 2024
Access Thyroglobulin
Beckman Coulter, Inc.
Immunology
18d
Cleared
Sep 30, 2023
Elecsys Tg II
Roche Diagnostics
Immunology
458d
Cleared
Sep 15, 2023
Access Thyroglobulin
Beckman Coulter, Inc.
Immunology
529d
Cleared
May 02, 2003
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Beckman Coulter, Inc.
Immunology
11d
Cleared
Oct 19, 2000
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
Beckman Coulter, Inc.
Immunology
31d
Cleared
Mar 12, 1999
IMMULITE THYROGLOBULIN MODEL LKTY
Diagnostic Products Corp.
Immunology
240d
Cleared
Mar 12, 1999
IMMULITE 2000 THYROGLOBULIN MODEL L2KTY
Diagnostic Products Corp.
Immunology
240d
About Product Code MSW - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code MSW since 1999, with 13 receiving FDA clearance (average review time: 178 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA 510(k) Review Time - MSW Product Code
Recent submissions under MSW have taken an average of 267 days to reach a decision - up from 171 days historically. Manufacturers should account for longer review timelines in current project planning.
MSW devices are reviewed by the Immunology panel. Browse all Immunology devices →