Cleared Traditional

NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT (K962208) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

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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
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.

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All 83
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