CGR · Radioimmunoassay, Cortisol
Clinical Chemistry · 21 CFR 862.1205 · Class 2
Overview
| Product Code | CGR |
|---|---|
| Device Name | Radioimmunoassay, Cortisol |
| Regulation | 21 CFR 862.1205 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Classification Rationale
Class II.
Cleared Devices (84)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. | Mar 5, 2025 | SESE |
| K223038 | Access Cortisol | Beckman Coulter, Inc. | Feb 8, 2023 | SESE |
| K202136 | IDS Cortisol | Immunodiagnostic Systems , Ltd. | Apr 13, 2021 | SESE |
| K203270 | IMMULITE/IMMULITE® 1000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | Jan 15, 2021 | SESE |
| K202826 | IMMULITE® 2000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | Jan 15, 2021 | SESE |
| K062626 | CORTISOL ELISA | Ibl-Hamburg GmbH | Dec 20, 2006 | SESE |
| K060480 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS | Ortho-Clinical Diagnostics | Jul 3, 2006 | SESE |
| K052359 | IBL CORTISOL LIA TEST KIT | Lehnus & Associates Consulting | Oct 3, 2005 | SESE |
| K050202 | CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | Feb 9, 2005 | SESE |
| K042689 | NICHOLS ADVANTAGE CORTISOL | Nichols Institute Diagnostics | Dec 9, 2004 | SESE |
| K010790 | CORTISOL LIA | Kmi Diagnostics, Inc. | Jan 29, 2002 | SESE |
| K984520 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 | Nichols Institute Diagnostics | Feb 5, 1999 | SESE |
| K983990 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY | Ortho-Clinical Diagnostics, Inc. | Dec 29, 1998 | SESE |
| K962208 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT | Nichols Institute Diagnostics | Apr 8, 1997 | SESE |
| K954733 | ACCESS CORTISOL ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | Dec 5, 1995 | SESE |
| K945367 | CIBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | May 5, 1995 | SESE |
| K943427 | ACE CEDIA CORTISOL ASSAY | Schiapparelli Biosystems, Inc. | Nov 28, 1994 | SESE |
| K940221 | ACCESS CORTISOL REAGENTS | Bio-Rad Laboratories, Inc. | Apr 26, 1994 | SESE |
| K931177 | SYNELISA CORTISOL | Elias U.S.A., Inc. | Sep 27, 1993 | SESE |
| K931409 | IMMULITE CORTISOL | Diagnostic Products Corp. | May 11, 1993 | SESE |
| K922676 | CORTISOL CHEMILUMINESCENCE ASSAY | Nichols Institute | Jul 10, 1992 | SESE |
| K914886 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) | Serono-Baker Diagnostics, Inc. | Mar 2, 1992 | SESE |
| K905473 | UBI MAGIWEL CORTISOL QUANTITATIVE | United Biotech, Inc. | Jan 31, 1991 | SESE |
| K903975 | SEROZYME CORTISOL TEST KIT | Serono-Baker Diagnostics, Inc. | Jan 23, 1991 | SESE |
| K900485 | ENZYMUN TEST(R) CORTISOL | Boehringer Mannheim Corp. | May 2, 1990 | SESE |
| K901296 | CEDIA (TM) CORTISOL ASSAY | Microgenics Corp. | Apr 3, 1990 | SESE |
| K896451 | MODIFIED CEDIA(TM) CORTISOL ASSAY | Microgenics Corp. | Dec 12, 1989 | SESE |
| K895006 | MILENIA(TM) CORTISOL (MKCO1,5) | Diagnostic Products Corp. | Oct 23, 1989 | SESE |
| K895407 | CORTISOL CLASP-BEAD EIA KIT | Biotecx Laboratories, Inc. | Oct 19, 1989 | SESE |
| K884689 | DSL 7800 ACTIVE CORTISOL | Diagnostic Systems Laboratories, Inc. | Feb 23, 1989 | SESE |
| K880687 | CORTISOL ENHANCED LUMINESCENCE ASSAY KIT | Amersham Corp. | Mar 24, 1988 | SESE |
| K870969 | CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT | Canadian Bioclinical, Ltd. | Jun 22, 1987 | SESE |
| K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT | Nuclear Diagnostics, Inc. | Jun 17, 1987 | SESE |
| K862336 | PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | Sep 25, 1986 | SESE |
| K862871 | RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL | Cambridge Medical Technology | Aug 19, 1986 | SESE |
| K852939 | CORTISOL SYSTEM BY EIA | American Bioclinical, Inc. | Aug 2, 1985 | SESE |
| K850141 | ACTIVE CORTISOL DSL 2000-SP | Diagnostic Systems Laboratories, Inc. | Feb 6, 1985 | SESE |
| K850008 | SOPHEIA/MP CORTISOL EIA KIT | Diagnostic Products Corp. | Feb 1, 1985 | SESE |
| K843384 | LEECO CORTISOL-QUANT | Leeco Diagnostics, Inc. | Sep 28, 1984 | SESE |
| K843183 | STRATUS CORTISOL FLUOROMETRIC ENZYME | American Dade | Sep 17, 1984 | SESE |
| K842957 | CORITSOL PREMIX RIA KIT | Biotecx Laboratories, Inc. | Sep 14, 1984 | SESE |
| K841641 | CORNING MAGIC CORTISOL RADIOIMMUNO | Corning Medical & Scientific | Sep 4, 1984 | SESE |
| K842455 | AMER. BIO-SCIENCE LAB CORTISOL REAGENT | American Bio-Science Laboratories | Aug 16, 1984 | SESE |
| K842365 | CORTI-COTE CORTISOL SOLID PHASE RADIO | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 16, 1984 | SESE |
| K842554 | IMMPULSE CORTISOL ASSAY REAGENTS | Aktis Corp. | Aug 12, 1984 | SESE |
| K840466 | NML CORTISOL RIA | Nuclear Medical Laboratories, Inc. | Mar 30, 1984 | SESE |
| K834219 | PHASE II CORTISOL KIT | Medical & Scientific Designs, Inc. | Feb 4, 1984 | SESE |
| K832638 | CORTISOL RADIOIMMUNOASSAY KIT | Bioclinical Group | Sep 12, 1983 | SESE |
| K831141 | EMIT SRD MANUAL CORTISOL ASSAY | Syva Co. | May 27, 1983 | SESE |
| K830563 | CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK | Sorin Biomedica, Fiat, USA, Inc. | May 13, 1983 | SESE |
| K830148 | CORTISOL KIT | Cambridge Medical Technology | Feb 9, 1983 | SESE |
| K822892 | CORTISOL RIA KIT | Antibodies, Inc. | Nov 1, 1982 | SESE |
| K822845 | SOPHEIA CORTISOL EIA KIT | Diagnostic Products Corp. | Oct 27, 1982 | SESE |
| K821931 | ZETA-CORT | Amf Biological and Diagnostics Co. | Jul 22, 1982 | SESE |
| K821068 | DSL 1020 | Diagnostic Systems Laboratories, Inc. | May 5, 1982 | SESE |
| K820341 | CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT | E. R. Squibb & Sons, Inc. | Mar 4, 1982 | SESE |
| K820074 | CORTISOL (RIA) KIT | Immuno Assay Corp. | Jan 28, 1982 | SESE |
| K810891 | COAT-A-COUNT CORTISOL RIA KIT | Diagnostic Products Corp. | Apr 14, 1981 | SESE |
| K810192 | ENDAB CORTISOL KIT | Immunotech Corp. | Feb 6, 1981 | SESE |
| K810033 | CORTI-SHURE | Nuclear Medical Laboratories, Inc. | Jan 21, 1981 | SESE |
| K802969 | CORTISOL 125-I RADIOIMMUNOASSAY KIT | Ria Products, Inc. | Jan 2, 1981 | SESE |
| K802380 | ARIA II 125 I CORTISOL | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 31, 1980 | SESE |
| K802036 | CORTISOL125 RADIOIMMUNOASSAY | Corning Medical & Scientific | Oct 23, 1980 | SESE |
| K801203 | CORTISOL RADIOIMMUNOASSAY KIT | Technia Diagnostics , Ltd. | Jun 9, 1980 | SESE |
| K800538 | GAMMA STICK CORTISOL RIA KIT/STICK KIT | Alpha Gamma Laboratory | Apr 24, 1980 | SESE |
| K800700 | AMERLEX CORTISOL RIA KIT | Amersham Corp. | Apr 16, 1980 | SESE |
| K800594 | VENTRE/SEP CORTISOL RIA | Ventrex Laboratories, Inc. | Apr 4, 1980 | SESE |
| K800245 | EMIT AUTO CORTISOL ASSAY | Syva Co. | Mar 3, 1980 | SESE |
| K800045 | QUANTIMUNE CORTISOL RIA CORTISOL RADIO- | Bio-Rad | Jan 23, 1980 | SESE |
| K792439 | ANALYTE CORTISOL | Technicon Instruments Corp. | Jan 17, 1980 | SESE |
| K792243 | CENTRIA CORTISOL RIA TEST SET | Ventrex Laboratories, Inc. | Dec 6, 1979 | SESE |
| K792036 | CORTISOL RADIOIMMUNOASSAY SYSTEM | Radioimmunoassay, Inc. | Oct 30, 1979 | SESE |
| K791700 | CORTI-SHURE | Nuclear Medical Laboratories, Inc. | Oct 1, 1979 | SESE |
| K791835 | CORALENT COAT 125I CORTISOL RADIOIMM. | Radioassay Systems Laboratories, Inc. | Sep 27, 1979 | SESE |
| K790906 | AUTOPAK CORTISOL TEST DELIVERY SYSTEM | Micromedic Systems | Jun 27, 1979 | SESE |
| K790268 | CORTISOL RIA KIT | E. R. Squibb & Sons, Inc. | Apr 4, 1979 | SESE |
| K782110 | RIA KIT, RIANEN CORTISOL | New England Nuclear | Jan 26, 1979 | SESE |
| K781903 | RIA KIT, QUANTITOPE CORTISOL | Kallestad Laboratories, Inc. | Jan 26, 1979 | SESE |
| K781730 | RIA, CORTISOL KIT | Radioassay Systems Laboratories, Inc. | Nov 22, 1978 | SESE |
| K780725 | CENTRIA CORTISOL RIA | Union Carbide Corp. | Jun 6, 1978 | SESE |
| K771117 | CENTRIA CORTISOL RIA | Clinical Diagnostics, Inc. | Jun 23, 1977 | SESE |
| K761346 | RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) | New England Nuclear | Jan 7, 1977 | SESE |
| K760939 | CORTISOL REAGENT SYSTEM | Beckman Instruments, Inc. | Nov 16, 1976 | SESE |
| K760256 | TEST SYSTEM, RIA CORTISOL | Corning Medical & Scientific | Aug 11, 1976 | SESE |
Top Applicants
- Diagnostic Products Corp. — 5 clearances
- Nuclear Medical Laboratories, Inc. — 3 clearances
- Nichols Institute Diagnostics — 3 clearances
- Diagnostic Systems Laboratories, Inc. — 3 clearances
- Corning Medical & Scientific — 3 clearances
