Product Code: CGR FDA class 2 21 CFR 862.1205

Radioimmunoassay, Cortisol

Clinical Chemistry

The Radioimmunoassay, Cortisol test system (product code CGR) is an in-vitro diagnostic device used in clinical chemistry to measure cortisol levels in serum, plasma, or urine using a radioimmunoassay method, aiding in the diagnosis of adrenal disorders such as Cushing's syndrome and Addison's disease. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1205 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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FEI Numbers

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Unique Applicants

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Basic Information

Product Code: CGR
Device Class: FDA class 2
Regulation Number: 862.1205
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 84 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242190	Access Cortisol; DxC 500i Clinical Analyzer	Mar 05, 2025	Substantially Equivalent	Beckman Coulter, Inc.
K223038	Access Cortisol	Feb 08, 2023	Substantially Equivalent	Beckman Coulter, Inc.
K202136	IDS Cortisol	Apr 13, 2021	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K203270	IMMULITE/IMMULITE® 1000 Cortisol	Jan 15, 2021	Substantially Equivalent	Siemens Healthcare Diagnostics Products, Ltd.
K202826	IMMULITE® 2000 Cortisol	Jan 15, 2021	Substantially Equivalent	Siemens Healthcare Diagnostics Products, Ltd.
K062626	CORTISOL ELISA	Dec 20, 2006	Substantially Equivalent	Ibl-Hamburg GmbH
K060480	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS	Jul 03, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics
K052359	IBL CORTISOL LIA TEST KIT	Oct 03, 2005	Substantially Equivalent	Lehnus & Associates Consulting
K050202	CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS	Feb 09, 2005	Substantially Equivalent	Beckman Coulter, Inc.
K042689	NICHOLS ADVANTAGE CORTISOL	Dec 09, 2004	Substantially Equivalent	Nichols Institute Diagnostics
K010790	CORTISOL LIA	Jan 29, 2002	Substantially Equivalent	Kmi Diagnostics, Inc.
K984520	NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005	Feb 05, 1999	Substantially Equivalent	Nichols Institute Diagnostics
K983990	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY	Dec 29, 1998	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K962208	NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT	Apr 08, 1997	Substantially Equivalent	Nichols Institute Diagnostics
K954733	ACCESS CORTISOL ASSAY (MODIFICATION)	Dec 05, 1995	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K945367	CIBA CORNING ACS CORTISOL IMMUNOASSAY	May 05, 1995	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K943427	ACE CEDIA CORTISOL ASSAY	Nov 28, 1994	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K940221	ACCESS CORTISOL REAGENTS	Apr 26, 1994	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K931177	SYNELISA CORTISOL	Sep 27, 1993	Substantially Equivalent	Elias U.S.A., Inc.
K931409	IMMULITE CORTISOL	May 11, 1993	Substantially Equivalent	Diagnostic Products Corp.
K922676	CORTISOL CHEMILUMINESCENCE ASSAY	Jul 10, 1992	Substantially Equivalent	Nichols Institute
K914886	SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)	Mar 02, 1992	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K905473	UBI MAGIWEL CORTISOL QUANTITATIVE	Jan 31, 1991	Substantially Equivalent	United Biotech, Inc.
K903975	SEROZYME CORTISOL TEST KIT	Jan 23, 1991	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K900485	ENZYMUN TEST(R) CORTISOL	May 02, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K901296	CEDIA (TM) CORTISOL ASSAY	Apr 03, 1990	Substantially Equivalent	Microgenics Corp.
K896451	MODIFIED CEDIA(TM) CORTISOL ASSAY	Dec 12, 1989	Substantially Equivalent	Microgenics Corp.
K895006	MILENIA(TM) CORTISOL (MKCO1,5)	Oct 23, 1989	Substantially Equivalent	Diagnostic Products Corp.
K895407	CORTISOL CLASP-BEAD EIA KIT	Oct 19, 1989	Substantially Equivalent	Biotecx Laboratories, Inc.
K884689	DSL 7800 ACTIVE CORTISOL	Feb 23, 1989	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K880687	CORTISOL ENHANCED LUMINESCENCE ASSAY KIT	Mar 24, 1988	Substantially Equivalent	Amersham Corp.
K870969	CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT	Jun 22, 1987	Substantially Equivalent	Canadian Bioclinical, Ltd.
K872177	TIPSEP-CORTISOL RIA DIAGNOSTIC KIT	Jun 17, 1987	Substantially Equivalent	Nuclear Diagnostics, Inc.
K862336	PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT	Sep 25, 1986	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K862871	RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL	Aug 19, 1986	Substantially Equivalent	Cambridge Medical Technology
K852939	CORTISOL SYSTEM BY EIA	Aug 02, 1985	Substantially Equivalent	American Bioclinical, Inc.
K850141	ACTIVE CORTISOL DSL 2000-SP	Feb 06, 1985	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K850008	SOPHEIA/MP CORTISOL EIA KIT	Feb 01, 1985	Substantially Equivalent	Diagnostic Products Corp.
K843384	LEECO CORTISOL-QUANT	Sep 28, 1984	Substantially Equivalent	Leeco Diagnostics, Inc.
K843183	STRATUS CORTISOL FLUOROMETRIC ENZYME	Sep 17, 1984	Substantially Equivalent	American Dade
K842957	CORITSOL PREMIX RIA KIT	Sep 14, 1984	Substantially Equivalent	Biotecx Laboratories, Inc.
K841641	CORNING MAGIC CORTISOL RADIOIMMUNO	Sep 04, 1984	Substantially Equivalent	Corning Medical & Scientific
K842455	AMER. BIO-SCIENCE LAB CORTISOL REAGENT	Aug 16, 1984	Substantially Equivalent	American Bio-Science Laboratories
K842365	CORTI-COTE CORTISOL SOLID PHASE RADIO	Aug 16, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K842554	IMMPULSE CORTISOL ASSAY REAGENTS	Aug 12, 1984	Substantially Equivalent	Aktis Corp.
K840466	NML CORTISOL RIA	Mar 30, 1984	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K834219	PHASE II CORTISOL KIT	Feb 04, 1984	Substantially Equivalent	Medical & Scientific Designs, Inc.
K832638	CORTISOL RADIOIMMUNOASSAY KIT	Sep 12, 1983	Substantially Equivalent	Bioclinical Group
K831141	EMIT SRD MANUAL CORTISOL ASSAY	May 27, 1983	Substantially Equivalent	Syva Co.
K830563	CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK	May 13, 1983	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K830148	CORTISOL KIT	Feb 09, 1983	Substantially Equivalent	Cambridge Medical Technology
K822892	CORTISOL RIA KIT	Nov 01, 1982	Substantially Equivalent	Antibodies, Inc.
K822845	SOPHEIA CORTISOL EIA KIT	Oct 27, 1982	Substantially Equivalent	Diagnostic Products Corp.
K821931	ZETA-CORT	Jul 22, 1982	Substantially Equivalent	Amf Biological and Diagnostics Co.
K821068	DSL 1020	May 05, 1982	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K820341	CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT	Mar 04, 1982	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K820074	CORTISOL (RIA) KIT	Jan 28, 1982	Substantially Equivalent	Immuno Assay Corp.
K810891	COAT-A-COUNT CORTISOL RIA KIT	Apr 14, 1981	Substantially Equivalent	Diagnostic Products Corp.
K810192	ENDAB CORTISOL KIT	Feb 06, 1981	Substantially Equivalent	Immunotech Corp.
K810033	CORTI-SHURE	Jan 21, 1981	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K802969	CORTISOL 125-I RADIOIMMUNOASSAY KIT	Jan 02, 1981	Substantially Equivalent	Ria Products, Inc.
K802380	ARIA II 125 I CORTISOL	Oct 31, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K802036	CORTISOL125 RADIOIMMUNOASSAY	Oct 23, 1980	Substantially Equivalent	Corning Medical & Scientific
K801203	CORTISOL RADIOIMMUNOASSAY KIT	Jun 09, 1980	Substantially Equivalent	Technia Diagnostics , Ltd.
K800538	GAMMA STICK CORTISOL RIA KIT/STICK KIT	Apr 24, 1980	Substantially Equivalent	Alpha Gamma Laboratory
K800700	AMERLEX CORTISOL RIA KIT	Apr 16, 1980	Substantially Equivalent	Amersham Corp.
K800594	VENTRE/SEP CORTISOL RIA	Apr 04, 1980	Substantially Equivalent	Ventrex Laboratories, Inc.
K800245	EMIT AUTO CORTISOL ASSAY	Mar 03, 1980	Substantially Equivalent	Syva Co.
K800045	QUANTIMUNE CORTISOL RIA CORTISOL RADIO-	Jan 23, 1980	Substantially Equivalent	Bio-Rad
K792439	ANALYTE CORTISOL	Jan 17, 1980	Substantially Equivalent	Technicon Instruments Corp.
K792243	CENTRIA CORTISOL RIA TEST SET	Dec 06, 1979	Substantially Equivalent	Ventrex Laboratories, Inc.
K792036	CORTISOL RADIOIMMUNOASSAY SYSTEM	Oct 30, 1979	Substantially Equivalent	Radioimmunoassay, Inc.
K791700	CORTI-SHURE	Oct 01, 1979	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K791835	CORALENT COAT 125I CORTISOL RADIOIMM.	Sep 27, 1979	Substantially Equivalent	Radioassay Systems Laboratories, Inc.
K790906	AUTOPAK CORTISOL TEST DELIVERY SYSTEM	Jun 27, 1979	Substantially Equivalent	Micromedic Systems
K790268	CORTISOL RIA KIT	Apr 04, 1979	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K782110	RIA KIT, RIANEN CORTISOL	Jan 26, 1979	Substantially Equivalent	New England Nuclear
K781903	RIA KIT, QUANTITOPE CORTISOL	Jan 26, 1979	Substantially Equivalent	Kallestad Laboratories, Inc.
K781730	RIA, CORTISOL KIT	Nov 22, 1978	Substantially Equivalent	Radioassay Systems Laboratories, Inc.
K780725	CENTRIA CORTISOL RIA	Jun 06, 1978	Substantially Equivalent	Union Carbide Corp.
K771117	CENTRIA CORTISOL RIA	Jun 23, 1977	Substantially Equivalent	Clinical Diagnostics, Inc.
K761346	RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)	Jan 07, 1977	Substantially Equivalent	New England Nuclear
K760939	CORTISOL REAGENT SYSTEM	Nov 16, 1976	Substantially Equivalent	Beckman Instruments, Inc.
K760256	TEST SYSTEM, RIA CORTISOL	Aug 11, 1976	Substantially Equivalent	Corning Medical & Scientific