FDA Product Code CGR: Radioimmunoassay, Cortisol
Under FDA product code CGR, radioimmunoassay systems for cortisol measurement are cleared for the evaluation of adrenal function.
These assays measure cortisol levels in serum, plasma, urine, or saliva for the diagnosis of Cushing's syndrome, adrenal insufficiency, and congenital adrenal hyperplasia, and for monitoring steroid replacement therapy.
CGR devices are Class II medical devices, regulated under 21 CFR 862.1205 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Beckman Coulter, Inc. and Immunodiagnostic Systems , Ltd..
FDA 510(k) Cleared Radioimmunoassay, Cortisol Devices (Product Code CGR)
About Product Code CGR - Regulatory Context
510(k) Submission Activity
84 total 510(k) submissions under product code CGR since 1976, with 84 receiving FDA clearance (average review time: 64 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under CGR have taken an average of 223 days to reach a decision - up from 62 days historically. Manufacturers should account for longer review timelines in current project planning.
CGR devices are reviewed by the Chemistry panel. Browse all Chemistry devices →