FDA Product Code CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone
FDA product code CDZ covers radioimmunoassay systems for the measurement of testosterone and dihydrotestosterone in serum.
These assays quantify androgens involved in male sexual development, reproductive function, and secondary sex characteristics. Testosterone measurement is used in the diagnosis of hypogonadism, polycystic ovary syndrome, and monitoring of androgen replacement therapy.
CDZ devices are Class I medical devices, regulated under 21 CFR 862.1680 and reviewed by the FDA Immunology panel.
Leading manufacturers include Beckman Coulter, Inc., Immunodiagnostic Systems Limited and Roche Diagnostics.
FDA 510(k) Cleared Radioimmunoassay, Testosterones And Dihydrotestosterone Devices (Product Code CDZ)
About Product Code CDZ - Regulatory Context
510(k) Submission Activity
89 total 510(k) submissions under product code CDZ since 1978, with 89 receiving FDA clearance (average review time: 109 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 CDZ have taken an average of 220 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.
CDZ devices are reviewed by the Chemistry panel. Browse all Chemistry devices →