Radioimmunoassay, Cortisol
FDA product code CGR · Class II (moderate risk) · 21 CFR 862.1205 · Clinical Chemistry
84510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Diagnostic Products Corp. 5
- Corning Medical & Scientific 3
- Diagnostic Systems Laboratories, Inc. 3
- Nichols Institute Diagnostics 3
- Nuclear Medical Laboratories, Inc. 3
- Beckman Coulter Inc. 3
- Ortho-Clinical Diagnostics 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Serono-Baker Diagnostics, Inc. 2
- Bio-Rad Laboratories, Inc. 2
- Amersham Corp. 2
- Syva Co. 2
- Cambridge Medical Technology 2
- Ventrex Laboratories, Inc. 2
- Microgenics Corp. 2
- E. R. Squibb & Sons, Inc. 2
- Radioassay Systems Laboratories, Inc. 2
- Siemens Healthcare Diagnostics Products GmbH 2
- Biotecx Laboratories, Inc. 2
- New England Nuclear 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242190 | Access Cortisol; DxC 500i Clinical AnalyzerCGR · Traditional | Beckman Coulter, Inc. | 03/05/2025SE |
| K223038 | Access CortisolCGR · Traditional | Beckman Coulter, Inc. | 02/08/2023SE |
| K202136 | IDS CortisolCGR · Traditional | Immunodiagnostic Systems , Ltd. | 04/13/2021SE |
| K203270 | IMMULITE/IMMULITE® 1000 CortisolCGR · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 01/15/2021SE |
| K202826 | IMMULITE® 2000 CortisolCGR · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 01/15/2021SE |
| K062626 | Cortisol ElisaCGR · Traditional | Ibl-Hamburg GmbH | 12/20/2006SE |
| K060480 | Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism…CGR · Traditional | Ortho-Clinical Diagnostics | 07/03/2006SE |
| K052359 | Ibl Cortisol Lia Test KitCGR · Traditional | Lehnus & Associates Consulting | 10/03/2005SE |
| K050202 | Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsCGR · Special | Beckman Coulter, Inc. | 02/09/2005SE |
| K042689 | Nichols Advantage CortisolCGR · Traditional | Nichols Institute Diagnostics | 12/09/2004SE |
| K010790 | Cortisol LiaCGR · Traditional | Kmi Diagnostics, Inc. | 01/29/2002SE |
| K984520 | Nichols Advantage Chemiluminescence Cortisol Immunoassay, Model 62-7005CGR · Traditional | Nichols Institute Diagnostics | 02/05/1999SE |
| K983990 | Vitros Immunodiagnostic Products Cortisol AssayCGR · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/29/1998SE |
| K962208 | Nichols Advantage Chemiluminescence Cortisol KitCGR · Traditional | Nichols Institute Diagnostics | 04/08/1997SE |
| K954733 | Access Cortisol Assay (Modification)CGR · Traditional | Bio-Rad Laboratories, Inc. | 12/05/1995SE |
| K945367 | Ciba Corning Acs Cortisol ImmunoassayCGR · Traditional | Ciba Corning Diagnostics Corp. | 05/05/1995SE |
| K943427 | Ace Cedia Cortisol AssayCGR · Traditional | Schiapparelli Biosystems, Inc. | 11/28/1994SE |
| K940221 | Access Cortisol ReagentsCGR · Traditional | Bio-Rad Laboratories, Inc. | 04/26/1994SE |
| K931177 | Synelisa CortisolCGR · Traditional | Elias U.S.A., Inc. | 09/27/1993SE |
| K931409 | Immulite CortisolCGR · Traditional | Diagnostic Products Corp. | 05/11/1993SE |
| K922676 | Cortisol Chemiluminescence AssayCGR · Traditional | Nichols Institute | 07/10/1992SE |
| K914886 | Sri(Tm) Cortisol Enzyme Immunoassay(Mag Sol Phase)CGR · Traditional | Serono-Baker Diagnostics, Inc. | 03/02/1992SE |
| K905473 | Ubi Magiwel Cortisol QuantitativeCGR · Traditional | United Biotech, Inc. | 01/31/1991SE |
| K903975 | Serozyme Cortisol Test KitCGR · Traditional | Serono-Baker Diagnostics, Inc. | 01/23/1991SE |
| K900485 | Enzymun Test(R) CortisolCGR · Traditional | Boehringer Mannheim Corp. | 05/02/1990SE |
| K901296 | Cedia (TM) Cortisol AssayCGR · Traditional | Microgenics Corp. | 04/03/1990SE |
| K896451 | Modified Cedia(Tm) Cortisol AssayCGR · Traditional | Microgenics Corp. | 12/12/1989SE |
| K895006 | Milenia(Tm) Cortisol (MKCO1,5)CGR · Traditional | Diagnostic Products Corp. | 10/23/1989SE |
| K895407 | Cortisol Clasp-Bead Eia KitCGR · Traditional | Biotecx Laboratories, Inc. | 10/19/1989SE |
| K884689 | DSL 7800 Active CortisolCGR · Traditional | Diagnostic Systems Laboratories, Inc. | 02/23/1989SE |
| K880687 | Cortisol Enhanced Luminescence Assay KitCGR · Traditional | Amersham Corp. | 03/24/1988SE |
| K870969 | Cortisol-Ria Kit Coated Tube Radioimmunoassay KitCGR · Traditional | Canadian Bioclinical, Ltd. | 06/22/1987SE |
| K872177 | Tipsep-Cortisol Ria Diagnostic KitCGR · Traditional | Nuclear Diagnostics, Inc. | 06/17/1987SE |
| K862336 | Pancoat Cortisol Coated Tube Radioimmunoassay KitCGR · Traditional | Pantex, Div. Bio-Analysis, Inc. | 09/25/1986SE |
| K862871 | Radioimmunoassay of No Spin(Tm) CortisolCGR · Traditional | Cambridge Medical Technology | 08/19/1986SE |
| K852939 | Cortisol System by EiaCGR · Traditional | American Bioclinical, Inc. | 08/02/1985SE |
| K850141 | Active Cortisol DSL 2000-SPCGR · Traditional | Diagnostic Systems Laboratories, Inc. | 02/06/1985SE |
| K850008 | Sopheia/Mp Cortisol Eia KitCGR · Traditional | Diagnostic Products Corp. | 02/01/1985SE |
| K843384 | Leeco Cortisol-QuantCGR · Traditional | Leeco Diagnostics, Inc. | 09/28/1984SE |
| K843183 | Stratus Cortisol Fluorometric EnzymeCGR · Traditional | American Dade | 09/17/1984SE |
| K842957 | Coritsol Premix Ria KitCGR · Traditional | Biotecx Laboratories, Inc. | 09/14/1984SE |
| K841641 | Corning Magic Cortisol RadioimmunoCGR · Traditional | Corning Medical & Scientific | 09/04/1984SE |
| K842455 | Amer. Bio-Science Lab Cortisol ReagentCGR · Traditional | American Bio-Science Laboratories | 08/16/1984SE |
| K842365 | Corti-Cote Cortisol Solid Phase RadioCGR · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/16/1984SE |
| K842554 | Immpulse Cortisol Assay ReagentsCGR · Traditional | Aktis Corp. | 08/12/1984SE |
| K840466 | NML Cortisol RiaCGR · Traditional | Nuclear Medical Laboratories, Inc. | 03/30/1984SE |
| K834219 | Phase II Cortisol KitCGR · Traditional | Medical & Scientific Designs, Inc. | 02/04/1984SE |
| K832638 | Cortisol Radioimmunoassay KitCGR · Traditional | Bioclinical Group | 09/12/1983SE |
| K831141 | Emit SRD Manual Cortisol AssayCGR · Traditional | Syva Co. | 05/27/1983SE |
| K830563 | Cortisol Radioimmunoassay Kit-CortctkCGR · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/13/1983SE |
| K830148 | Cortisol KitCGR · Traditional | Cambridge Medical Technology | 02/09/1983SE |
| K822892 | Cortisol Ria KitCGR · Traditional | Antibodies, Inc. | 11/01/1982SE |
| K822845 | Sopheia Cortisol Eia KitCGR · Traditional | Diagnostic Products Corp. | 10/27/1982SE |
| K821931 | Zeta-CortCGR · Traditional | Amf Biological and Diagnostics Co. | 07/22/1982SE |
| K821068 | DSL 1020CGR · Traditional | Diagnostic Systems Laboratories, Inc. | 05/05/1982SE |
| K820341 | Cortisol-Squibb Radioimmunoassay KitCGR · Traditional | E. R. Squibb & Sons, Inc. | 03/04/1982SE |
| K820074 | Cortisol (Ria) KitCGR · Traditional | Immuno Assay Corp. | 01/28/1982SE |
| K810891 | Coat-A-Count Cortisol Ria KitCGR · Traditional | Diagnostic Products Corp. | 04/14/1981SE |
| K810192 | Endab Cortisol KitCGR · Traditional | Immunotech Corp. | 02/06/1981SE |
| K810033 | Corti-ShureCGR · Traditional | Nuclear Medical Laboratories, Inc. | 01/21/1981SE |
| K802969 | Cortisol 125-I Radioimmunoassay KitCGR · Traditional | Ria Products, Inc. | 01/02/1981SE |
| K802380 | Aria II 125 I CortisolCGR · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/31/1980SE |
| K802036 | CORTISOL125 RadioimmunoassayCGR · Traditional | Corning Medical & Scientific | 10/23/1980SE |
| K801203 | Cortisol Radioimmunoassay KitCGR · Traditional | Technia Diagnostics , Ltd. | 06/09/1980SE |
| K800538 | Gamma Stick Cortisol Ria Kit/Stick KitCGR · Traditional | Alpha Gamma Laboratory | 04/24/1980SE |
| K800700 | Amerlex Cortisol Ria KitCGR · Traditional | Amersham Corp. | 04/16/1980SE |
| K800594 | Ventre/Sep Cortisol RiaCGR · Traditional | Ventrex Laboratories, Inc. | 04/04/1980SE |
| K800245 | Emit Auto Cortisol AssayCGR · Traditional | Syva Co. | 03/03/1980SE |
| K800045 | Quantimune Cortisol Ria Cortisol Radio-CGR · Traditional | Bio-Rad | 01/23/1980SE |
| K792439 | Analyte CortisolCGR · Traditional | Technicon Instruments Corp. | 01/17/1980SE |
| K792243 | Centria Cortisol Ria Test SetCGR · Traditional | Ventrex Laboratories, Inc. | 12/06/1979SE |
| K792036 | Cortisol Radioimmunoassay SystemCGR · Traditional | Radioimmunoassay, Inc. | 10/30/1979SE |
| K791700 | Corti-ShureCGR · Traditional | Nuclear Medical Laboratories, Inc. | 10/01/1979SE |
| K791835 | Coralent Coat 125I Cortisol Radioimm.CGR · Traditional | Radioassay Systems Laboratories, Inc. | 09/27/1979SE |
| K790906 | Autopak Cortisol Test Delivery SystemCGR · Traditional | Micromedic Systems | 06/27/1979SE |
| K790268 | Cortisol Ria KitCGR · Traditional | E. R. Squibb & Sons, Inc. | 04/04/1979SE |
| K782110 | Ria Kit, Rianen CortisolCGR · Traditional | New England Nuclear | 01/26/1979SE |
| K781903 | Ria Kit, Quantitope CortisolCGR · Traditional | Kallestad Laboratories, Inc. | 01/26/1979SE |
| K781730 | Ria, Cortisol KitCGR · Traditional | Radioassay Systems Laboratories, Inc. | 11/22/1978SE |
| K780725 | Centria Cortisol RiaCGR · Traditional | Union Carbide Corp. | 06/06/1978SE |
| K771117 | Centria Cortisol RiaCGR · Traditional | Clinical Diagnostics, Inc. | 06/23/1977SE |
| K761346 | Radioimmunoassay Kit(Cortisol in Plasma)CGR · Traditional | New England Nuclear | 01/07/1977SE |
| K760939 | Cortisol Reagent SystemCGR · Traditional | Beckman Instruments, Inc. | 11/16/1976SE |
| K760256 | Test System, Ria CortisolCGR · Traditional | Corning Medical & Scientific | 08/11/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0215-2026 Class II | DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number…Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i… | Beckman Coulter, Inc. | 09/19/2025Open, Classified |
| Z-0032-2026 Class II | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC…On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an… | Beckman Coulter Inc. | 08/04/2025Open, Classified |
| Z-0313-2025 Class II | The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for…The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at… | Beckman Coulter, Inc. | 09/30/2024Open, Classified |
| Z-2763-2019 Class II | The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic…Cross contamination may have occurred between wells for the reagent pack. As a result of this defect… | Beckman Coulter Inc. | 09/18/2018Terminated |
| Z-0122-2015 Class II | IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388…Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE… | Siemens Healthcare Diagnostics | 09/19/2014Terminated |
| Z-2621-2010 | Access Immunoassay Systems CORTISOL, Part Number: 33600The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot… | Beckman Coulter Inc. | 02/17/2010Terminated |
| Z-2761-2011 | Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme…The recall was initiated because Beckman Coulter has confirmed that the listed lot numbers of Active Control… | Beckman Coulter Inc. | 07/20/2009Terminated |