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..
FDA 510(k) Cleared System, Test, Thyroglobulin Devices (Product Code MSW)
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 increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MSW have taken an average of 123 days to reach a decision - down from 195 days historically, suggesting improved FDA processing for this classification.
MSW devices are reviewed by the Immunology panel. Browse all Immunology devices →