JFT · Class II · 21 CFR 862.1205

FDA Product Code JFT: Fluorometric, Cortisol

Leading manufacturers include Ciba Corning Diagnostics Corp., Siemens Healthcare Diagnostics, Inc. and Roche Diagnostics.

20
Total
20
Cleared
125d
Avg days
1983
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 329d recently vs 114d historically

FDA 510(k) Cleared Fluorometric, Cortisol Devices (Product Code JFT)

20 devices
1–20 of 20
Cleared Jul 17, 2025
Elecsys Cortisol III
K242505
Roche Diagnostics
Chemistry · 329d
Cleared Nov 25, 2019
ADVIA Centaur Cortisol (COR)
K192788
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Apr 27, 2016
Elecsys Cortisol II, Cortisol II CalSet
K152227
Roche Diagnostics
Chemistry · 264d
Cleared Mar 31, 2015
ADVIA Centaur Cortisol (COR) Assy
K142723
Siemens Healthcare Diagnostics, Inc.
Chemistry · 189d
Cleared Feb 20, 2004
AXSYM CORTISOL ASSAY
K033731
Fujirebio Diagnostics,Inc.
Chemistry · 84d
Cleared Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
K021218
Roche Diagnostics Corp.
Chemistry · 145d
Cleared Nov 05, 1996
ACS CORTISOL IMMUNOASSAY
K962559
Ciba Corning Diagnostics Corp.
Chemistry · 127d
Cleared Dec 15, 1995
AIA-PACK CORT ASSAY
K954591
Tosoh Medics, Inc.
Chemistry · 74d
Cleared May 13, 1994
CIDBA CORNING ACS CORTISOL IMMUNOASSAY
K934317
Ciba Corning Diagnostics Corp.
Chemistry · 254d
Cleared Jul 27, 1993
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
K931031
Biomerieux Vitek, Inc.
Chemistry · 148d
Cleared May 26, 1993
ACCESS(R) CORTISOL REAGENTS
K926322
Bio-Rad Laboratories, Inc.
Chemistry · 161d
Cleared Apr 03, 1990
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
K900010
Kallestad Diag, A Div. of Erbamont, Inc.
Toxicology · 91d
Cleared Dec 07, 1989
CORTISOL TEST SYSTEM
K895421
Baxter Healthcare Corp
Chemistry · 97d
Cleared Oct 31, 1989
CEDIA CORTISOL ASSAY
K893954
Microgenics Corp.
Chemistry · 152d
Cleared Sep 26, 1986
DELFIA(TM) CORTISOL KIT
K863422
Lkb Instruments, Inc.
Chemistry · 22d
Cleared Nov 25, 1985
TDX CORTISOL
K854419
Abbott Laboratories
Chemistry · 21d
Cleared Aug 05, 1985
TDX CORTISOL
K852927
Abbott Laboratories
Chemistry · 27d
Cleared Dec 29, 1983
SYVA ADVANCE CORTISOL ASSAY
K833932
Syva Co.
Toxicology · 45d

About Product Code JFT - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code JFT since 1983, with 20 receiving FDA clearance (average review time: 125 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JFT Product Code

Recent submissions under JFT have taken an average of 329 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.

JFT devices are reviewed by the Chemistry panel. Browse all Chemistry devices →