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., Corning Medical & Scientific and Nichols Institute Diagnostics.
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
Jul 03, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
Ortho-Clinical Diagnostics
Chemistry
130d
Cleared
Feb 09, 2005
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Beckman Coulter, Inc.
Chemistry
12d
Cleared
Dec 09, 2004
NICHOLS ADVANTAGE CORTISOL
Nichols Institute Diagnostics
Chemistry
71d
Cleared
Feb 05, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
Nichols Institute Diagnostics
Chemistry
46d
Cleared
Dec 29, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY
Ortho-Clinical Diagnostics, Inc.
Chemistry
50d
Cleared
Apr 08, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
Nichols Institute Diagnostics
Chemistry
302d
Cleared
Dec 05, 1995
ACCESS CORTISOL ASSAY (MODIFICATION)
Bio-Rad Laboratories, Inc.
Chemistry
64d
Cleared
May 05, 1995
CIBA CORNING ACS CORTISOL IMMUNOASSAY
Ciba Corning Diagnostics Corp.
Chemistry
221d
Cleared
Apr 26, 1994
ACCESS CORTISOL REAGENTS
Bio-Rad Laboratories, Inc.
Toxicology
98d
Cleared
Sep 27, 1993
SYNELISA CORTISOL
Elias U.S.A., Inc.
Chemistry
202d
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
Apr 03, 1990
CEDIA (TM) CORTISOL ASSAY
Microgenics Corp.
Chemistry
14d
Cleared
Dec 12, 1989
MODIFIED CEDIA(TM) CORTISOL ASSAY
Microgenics Corp.
Chemistry
33d
Cleared
Oct 23, 1989
MILENIA(TM) CORTISOL (MKCO1,5)
Diagnostic Products Corp.
Chemistry
76d
Cleared
Feb 23, 1989
DSL 7800 ACTIVE CORTISOL
Diagnostic Systems Laboratories, Inc.
Chemistry
107d
Cleared
Mar 24, 1988
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
Amersham Corp.
Chemistry
31d
Cleared
Feb 06, 1985
ACTIVE CORTISOL DSL 2000-SP
Diagnostic Systems Laboratories, Inc.
Chemistry
23d
Cleared
Feb 01, 1985
SOPHEIA/MP CORTISOL EIA KIT
Diagnostic Products Corp.
Chemistry
30d
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 →