Cleared Traditional

K922676 - CORTISOL CHEMILUMINESCENCE ASSAY

K922676 is an FDA 510(k) clearance for CORTISOL CHEMILUMINESCENCE ASSAY, manufactured by Nichols Institute. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K922676 · Nichols Institute · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
36d
Days
Class 2
Risk

K922676 is an FDA 510(k) clearance for the CORTISOL CHEMILUMINESCENCE ASSAY. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Nichols Institute (San Juan Capistrano, US). The FDA issued a Cleared decision on July 10, 1992 after a review of 36 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 Nichols Institute devices

FDA 510(k) Submission Details - K922676

510(k) Number K922676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date July 10, 1992
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGR Device Classification - Class 2, Special Controls

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 60
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K922676.
ACCESS CORTISOL REAGENTS
K940221 · Bio-Rad Laboratories, Inc. · Apr 1994
SYNELISA CORTISOL
K931177 · Elias U.S.A., Inc. · Sep 1993
IMMULITE CORTISOL
K931409 · Diagnostic Products Corp. · May 1993
SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
K914886 · Serono-Baker Diagnostics, Inc. · Mar 1992
UBI MAGIWEL CORTISOL QUANTITATIVE
K905473 · United Biotech, Inc. · Jan 1991
SEROZYME CORTISOL TEST KIT
K903975 · Serono-Baker Diagnostics, Inc. · Jan 1991