Cleared Traditional

K926322 - ACCESS CORTISOL REAGENTS

K926322 is the FDA 510(k) clearance for ACCESS CORTISOL REAGENTS by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code JFT) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K926322 · Bio-Rad Laboratories, Inc. · Chemistry device
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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
Combination Product No
PCCP Authorized No
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 15
Devices cleared under the same product code (JFT) and FDA review panel - the closest regulatory comparables to K926322.
ACS CORTISOL IMMUNOASSAY
K962559 · Ciba Corning Diagnostics Corp. · Nov 1996
CIDBA CORNING ACS CORTISOL IMMUNOASSAY
K934317 · Ciba Corning Diagnostics Corp. · May 1994
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
K931031 · Biomerieux Vitek, Inc. · Jul 1993
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
K900010 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1990
CORTISOL TEST SYSTEM
K895421 · Baxter Healthcare Corp · Dec 1989
CEDIA CORTISOL ASSAY
K893954 · Microgenics Corp. · Oct 1989