Cleared Traditional

K954733 - ACCESS CORTISOL ASSAY (MODIFICATION)

K954733 is the FDA 510(k) clearance for ACCESS CORTISOL ASSAY (MODIFICATION) by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K954733 · Bio-Rad Laboratories, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 1995
Decision
64d
Days
Class 2
Risk

K954733 is an FDA 510(k) clearance for the ACCESS CORTISOL ASSAY (MODIFICATION). Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on December 5, 1995 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K954733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date December 05, 1995
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGR Radioimmunoassay, 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 - CGR Radioimmunoassay, Cortisol

All 42
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K954733.
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
K984520 · Nichols Institute Diagnostics · Feb 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY
K983990 · Ortho-Clinical Diagnostics, Inc. · Dec 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
K962208 · Nichols Institute Diagnostics · Apr 1997
CIBA CORNING ACS CORTISOL IMMUNOASSAY
K945367 · Ciba Corning Diagnostics Corp. · May 1995
ACCESS CORTISOL REAGENTS
K940221 · Bio-Rad Laboratories, Inc. · Apr 1994
SYNELISA CORTISOL
K931177 · Elias U.S.A., Inc. · Sep 1993