JFT · Fluorometric, Cortisol
Clinical Chemistry · 21 CFR 862.1205 · Class 2
Overview
| Product Code | JFT |
|---|---|
| Device Name | Fluorometric, 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 (20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242505 | Elecsys Cortisol III | Roche Diagnostics | Jul 17, 2025 | SESE |
| K192788 | ADVIA Centaur Cortisol (COR) | Siemens Healthcare Diagnostics, Inc. | Nov 25, 2019 | SESE |
| K152227 | Elecsys Cortisol II, Cortisol II CalSet | Roche Diagnostics | Apr 27, 2016 | SESE |
| K142723 | ADVIA Centaur Cortisol (COR) Assy | Siemens Healthcare Diagnostics, Inc. | Mar 31, 2015 | SESE |
| K062204 | ARCHITECT CORTISOL ASSAY | Seradyn, Inc. | Sep 22, 2006 | SESE |
| K033731 | AXSYM CORTISOL ASSAY | Fujirebio Diagnostics,Inc. | Feb 20, 2004 | SESE |
| K021218 | ELECSYS CORTISOL TEST SYSTEM | Roche Diagnostics Corp. | Sep 9, 2002 | SESE |
| K962559 | ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Nov 5, 1996 | SESE |
| K954591 | AIA-PACK CORT ASSAY | Tosoh Medics, Inc. | Dec 15, 1995 | SESE |
| K934317 | CIDBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | May 13, 1994 | SESE |
| K931031 | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT | Biomerieux Vitek, Inc. | Jul 27, 1993 | SESE |
| K930732 | DELFIA CORTISOL KIT | Wallac OY | Jul 27, 1993 | SESE |
| K926322 | ACCESS(R) CORTISOL REAGENTS | Bio-Rad Laboratories, Inc. | May 26, 1993 | SESE |
| K900010 | NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR | Kallestad Diag, A Div. of Erbamont, Inc. | Apr 3, 1990 | SESE |
| K895421 | CORTISOL TEST SYSTEM | Baxter Healthcare Corp | Dec 7, 1989 | SESE |
| K893954 | CEDIA CORTISOL ASSAY | Microgenics Corp. | Oct 31, 1989 | SESE |
| K863422 | DELFIA(TM) CORTISOL KIT | Lkb Instruments, Inc. | Sep 26, 1986 | SESE |
| K854419 | TDX CORTISOL | Abbott Laboratories | Nov 25, 1985 | SESE |
| K852927 | TDX CORTISOL | Abbott Laboratories | Aug 5, 1985 | SESE |
| K833932 | SYVA ADVANCE CORTISOL ASSAY | Syva Co. | Dec 29, 1983 | SESE |
Top Applicants
- Siemens Healthcare Diagnostics, Inc. — 2 clearances
- Roche Diagnostics — 2 clearances
- Ciba Corning Diagnostics Corp. — 2 clearances
- Abbott Laboratories — 2 clearances
- Wallac OY — 1 clearance
