Cleared Traditional

K962208 - NICHOLS ADVANTAGE CHEMILUMINESCENCE COR...

K962208 is the FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE COR... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K962208 · Nichols Institute Diagnostics · Chemistry device
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Apr 1997
Decision
302d
Days
Class 2
Risk

K962208 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on April 8, 1997 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K962208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1996
Decision Date April 08, 1997
Days to Decision 302 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 88d · This submission: 302d
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 K962208.
NICHOLS ADVANTAGE CORTISOL
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K954733 · Bio-Rad Laboratories, Inc. · Dec 1995
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K945367 · Ciba Corning Diagnostics Corp. · May 1995
ACCESS CORTISOL REAGENTS
K940221 · Bio-Rad Laboratories, Inc. · Apr 1994