Product Code: JFT FDA class 2 21 CFR 862.1205

Fluorometric, Cortisol

Clinical Chemistry

Fluorometric Cortisol measurement is a clinical chemistry test system that uses fluorescence-based detection to quantify cortisol (hydrocortisone) levels in biological specimens, supporting the diagnosis of adrenal disorders such as Cushing's syndrome and Addison's disease. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JFT, regulated under 21 CFR 862.1205, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

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Basic Information

Product Code: JFT
Device Class: FDA class 2
Regulation Number: 862.1205
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242505	Elecsys Cortisol III	Jul 17, 2025	Substantially Equivalent	Roche Diagnostics
K192788	ADVIA Centaur Cortisol (COR)	Nov 25, 2019	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K152227	Elecsys Cortisol II, Cortisol II CalSet	Apr 27, 2016	Substantially Equivalent	Roche Diagnostics
K142723	ADVIA Centaur Cortisol (COR) Assy	Mar 31, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K062204	ARCHITECT CORTISOL ASSAY	Sep 22, 2006	Substantially Equivalent	Seradyn, Inc.
K033731	AXSYM CORTISOL ASSAY	Feb 20, 2004	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K021218	ELECSYS CORTISOL TEST SYSTEM	Sep 09, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K962559	ACS CORTISOL IMMUNOASSAY	Nov 05, 1996	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K954591	AIA-PACK CORT ASSAY	Dec 15, 1995	Substantially Equivalent	Tosoh Medics, Inc.
K934317	CIDBA CORNING ACS CORTISOL IMMUNOASSAY	May 13, 1994	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K931031	VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT	Jul 27, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K930732	DELFIA CORTISOL KIT	Jul 27, 1993	Substantially Equivalent	Wallac OY
K926322	ACCESS(R) CORTISOL REAGENTS	May 26, 1993	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K900010	NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR	Apr 03, 1990	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K895421	CORTISOL TEST SYSTEM	Dec 07, 1989	Substantially Equivalent	Baxter Healthcare Corp
K893954	CEDIA CORTISOL ASSAY	Oct 31, 1989	Substantially Equivalent	Microgenics Corp.
K863422	DELFIA(TM) CORTISOL KIT	Sep 26, 1986	Substantially Equivalent	Lkb Instruments, Inc.
K854419	TDX CORTISOL	Nov 25, 1985	Substantially Equivalent	Abbott Laboratories
K852927	TDX CORTISOL	Aug 05, 1985	Substantially Equivalent	Abbott Laboratories
K833932	SYVA ADVANCE CORTISOL ASSAY	Dec 29, 1983	Substantially Equivalent	Syva Co.