Cleared Traditional

K920247 - AMERLITE MAB FT4 ASSAY

K920247 is an FDA 510(k) clearance for AMERLITE MAB FT4 ASSAY, manufactured by Eastman Kodak Company. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K920247 · Eastman Kodak Company · Chemistry device
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Mar 1992
Decision
41d
Days
Class 2
Risk

K920247 is an FDA 510(k) clearance for the AMERLITE MAB FT4 ASSAY. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K920247

510(k) Number K920247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1992
Decision Date March 02, 1992
Days to Decision 41 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
48d faster than avg
Panel avg: 89d · This submission: 41d
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 91
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K920247.
VISTA FREE THYROXINE ASSAY
K923572 · Syva Co. · Nov 1992
KODAK AMERLITE MAB FT3 ASSAY
K922713 · Eastman Kodak Company · Oct 1992
ELEGANCE FT4 ELISA
K922284 · Bioclone Australia Pty , Ltd. · Jul 1992
LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY
K914835 · London Diagnostics, Inc. · Dec 1991
SR1 FREE T4 ENZYME IMMUNOASSAY
K912937 · Serono-Baker Diagnostics, Inc. · Nov 1991
AFFINITY FREE T4 TEST SYSTEM
K912698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
K920247 · AMERLITE MAB FT4 ASSAY
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