Cleared Traditional

K152227 - Elecsys Cortisol II

K152227 is the FDA 510(k) clearance for Elecsys Cortisol II by Roche Diagnostics. It is a Class 2 Chemistry device (product code JFT) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K152227 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
264d
Days
Class 2
Risk

K152227 is an FDA 510(k) clearance for the Elecsys Cortisol II, Cortisol II CalSet. Classified as Fluorometric, Cortisol (product code JFT), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 27, 2016 after a review of 264 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics devices

Submission Details

510(k) Number K152227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2015
Decision Date April 27, 2016
Days to Decision 264 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 88d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFT Fluorometric, Cortisol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1205
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JFT Fluorometric, Cortisol

All 12
Devices cleared under the same product code (JFT) and FDA review panel - the closest regulatory comparables to K152227.
Elecsys Cortisol III
K242505 · Roche Diagnostics · Jul 2025
ADVIA Centaur Cortisol (COR)
K192788 · Siemens Healthcare Diagnostics, Inc. · Nov 2019
ADVIA Centaur Cortisol (COR) Assy
K142723 · Siemens Healthcare Diagnostics, Inc. · Mar 2015
ELECSYS CORTISOL TEST SYSTEM
K021218 · Roche Diagnostics Corp. · Sep 2002
ACS CORTISOL IMMUNOASSAY
K962559 · Ciba Corning Diagnostics Corp. · Nov 1996
CIDBA CORNING ACS CORTISOL IMMUNOASSAY
K934317 · Ciba Corning Diagnostics Corp. · May 1994