Cleared Traditional

ACCESS(R) CORTISOL REAGENTS (K926322) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K926322 · Bio-Rad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
161d
Days
Class 2
Risk

K926322 is an FDA 510(k) clearance for the ACCESS(R) CORTISOL REAGENTS. Classified as Fluorometric, Cortisol (product code JFT), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 161 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K926322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1992
Decision Date May 26, 1993
Days to Decision 161 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 88d · This submission: 161d
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 19
Devices cleared under the same product code (JFT) and FDA review panel - the closest regulatory comparables to K926322.
Elecsys Cortisol III
K242505 · Roche Diagnostics · Jul 2025
ADVIA Centaur Cortisol (COR)
K192788 · Siemens Healthcare Diagnostics, Inc. · Nov 2019
CORTISOL TEST SYSTEM
K895421 · Baxter Healthcare Corp · Dec 1989
TDX CORTISOL
K854419 · Abbott Laboratories · Nov 1985
TDX CORTISOL
K852927 · Abbott Laboratories · Aug 1985
SYVA ADVANCE CORTISOL ASSAY
K833932 · Syva Co. · Dec 1983