Cleared Traditional

K042689 - NICHOLS ADVANTAGE CORTISOL

K042689 is the FDA 510(k) clearance for NICHOLS ADVANTAGE CORTISOL by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K042689 · Nichols Institute Diagnostics · Chemistry device
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Dec 2004
Decision
71d
Days
Class 2
Risk

K042689 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CORTISOL. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on December 9, 2004 after a review of 71 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 Diagnostics devices

Submission Details

510(k) Number K042689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2004
Decision Date December 09, 2004
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 45
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K042689.
IMMULITE/IMMULITE® 1000 Cortisol
K203270 · Siemens Healthcare Diagnostics Products, Ltd. · Jan 2021
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
K060480 · Ortho-Clinical Diagnostics · Jul 2006
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K050202 · Beckman Coulter, Inc. · Feb 2005
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