Cleared Traditional

K962408 - NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT

K962408 is an FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE FRE..., manufactured by Nichols Institute Diagnostics. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K962408

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.

CEC Device Classification - Class 2, Special Controls

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 78
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K962408.
SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY
K974551 · Sealite Sciences, Inc. · Dec 1997
IMMULITE FREE T4 (2-STEP)
K971792 · Diagnostic Products Corp. · Jul 1997
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
K971141 · Dade Chemistry Systems, Inc. · Apr 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
K965142 · Johnson & Johnson Clinical Diagnostics, Inc. · Mar 1997
ACA PLUS FREE THYROXINE(FT4) METHOD
K962602 · Dade Intl., Inc. · Aug 1996
ELECSYS FT4 ASSAY
K961489 · Boehringer Mannheim Corp. · Jun 1996