FDA Product Code JZO: System, Test, Thyroid Autoantibody
FDA product code JZO covers thyroid autoantibody test systems used in the diagnosis of autoimmune thyroid diseases.
These immunoassays detect antibodies against thyroid peroxidase (TPO), thyroglobulin, or TSH receptors in serum, enabling the diagnosis of Hashimoto's thyroiditis, Graves' disease, and other autoimmune thyroid conditions.
JZO devices are Class II medical devices, regulated under 21 CFR 866.5870 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, Thyroid Autoantibody Devices (Product Code JZO)
About Product Code JZO - Regulatory Context
510(k) Submission Activity
92 total 510(k) submissions under product code JZO since 1976, with 92 receiving FDA clearance (average review time: 104 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under JZO have taken an average of 217 days to reach a decision - up from 102 days historically. Manufacturers should account for longer review timelines in current project planning.
JZO devices are reviewed by the Immunology panel. Browse all Immunology devices →