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 Diagnostic Products Corp., Beckman Coulter, Inc. and Siemens Healthcare Diagnostics Products, Ltd..
84
Total
84
Cleared
64d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
223d
recently vs 62d historically
FDA 510(k) Cleared Radioimmunoassay, Cortisol Devices (Product Code CGR)
84 devices
Cleared
Mar 05, 2025
Access Cortisol
Beckman Coulter, Inc.
Chemistry
223d
Cleared
Feb 08, 2023
Access Cortisol
Beckman Coulter, Inc.
Chemistry
132d
Cleared
Apr 13, 2021
IDS Cortisol
Immunodiagnostic Systems , Ltd.
Chemistry
256d
Cleared
Jan 15, 2021
IMMULITE® 2000 Cortisol
Siemens Healthcare Diagnostics Products, Ltd.
Toxicology
113d
Cleared
Jan 15, 2021
IMMULITE/IMMULITE® 1000 Cortisol
Siemens Healthcare Diagnostics Products, Ltd.
Chemistry
71d
Cleared
Feb 09, 2005
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Beckman Coulter, Inc.
Chemistry
12d
Cleared
May 11, 1993
IMMULITE CORTISOL
Diagnostic Products Corp.
Chemistry
53d
Cleared
May 02, 1990
ENZYMUN TEST(R) CORTISOL
Boehringer Mannheim Corp.
Chemistry
90d
Cleared
Oct 23, 1989
MILENIA(TM) CORTISOL (MKCO1,5)
Diagnostic Products Corp.
Chemistry
76d
Cleared
Feb 01, 1985
SOPHEIA/MP CORTISOL EIA KIT
Diagnostic Products Corp.
Chemistry
30d
Cleared
Aug 16, 1984
CORTI-COTE CORTISOL SOLID PHASE RADIO
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
62d
Cleared
May 27, 1983
EMIT SRD MANUAL CORTISOL ASSAY
Syva Co.
Immunology
50d
Cleared
Oct 27, 1982
SOPHEIA CORTISOL EIA KIT
Diagnostic Products Corp.
Chemistry
34d
Cleared
Apr 14, 1981
COAT-A-COUNT CORTISOL RIA KIT
Diagnostic Products Corp.
Chemistry
12d
Cleared
Oct 31, 1980
ARIA II 125 I CORTISOL
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
30d
Cleared
Mar 03, 1980
EMIT AUTO CORTISOL ASSAY
Syva Co.
Chemistry
27d
Cleared
Jan 23, 1980
QUANTIMUNE CORTISOL RIA CORTISOL RADIO-
Bio-Rad
Chemistry
15d
Cleared
Nov 16, 1976
CORTISOL REAGENT SYSTEM
Beckman Instruments, Inc.
Chemistry
15d
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 510(k) Review Time - CGR Product Code
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 →