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.
Recent Cleared Devices (20 of 84)
Showing 20 most recent of 84 cleared devices.
| 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 |
Top Applicants
- Diagnostic Products Corp. — 5 clearances
- Beckman Coulter, Inc. — 3 clearances
- Corning Medical & Scientific — 3 clearances
- Diagnostic Systems Laboratories, Inc. — 3 clearances
- Nichols Institute Diagnostics — 3 clearances
