Cleared Traditional

K962408 - NICHOLS ADVANTAGE CHEMILUMINESCENCE FRE...

K962408 is the FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE FRE... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K962408 · Nichols Institute Diagnostics · Chemistry device
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Mar 1997
Decision
270d
Days
Class 2
Risk

K962408 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 270 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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. Standard predicate reliance. 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 K962408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1996
Decision Date March 18, 1997
Days to Decision 270 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
182d slower than avg
Panel avg: 88d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 63
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K962408.
ABBOTT ARCHITECT FREE T4
K983417 · Abbott Laboratories · Nov 1998
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K982250 · Beckman Instruments, Inc. · Jul 1998
IMMULITE FREE T4 (2-STEP)
K971792 · Diagnostic Products Corp. · Jul 1997
ELECSYS FT4 ASSAY
K961489 · Boehringer Mannheim Corp. · Jun 1996
COBAS CORE FREE T3 EIA
K942376 · Roche Diagnostic Systems, Inc. · Apr 1995
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
K944697 · Organon Teknika Corp. · Feb 1995