Cleared Traditional

K955097 - AMERLITE MAB FT4 ASSAY

K955097 is an FDA 510(k) clearance for AMERLITE MAB FT4 ASSAY, manufactured by Kodak Clinical Diagnostics, Ltd.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K955097 · Kodak Clinical Diagnostics, Ltd. · Chemistry device
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Dec 1995
Decision
43d
Days
Class 2
Risk

K955097 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 Kodak Clinical Diagnostics, Ltd. (Buckinghamshire, GB). The FDA issued a Cleared decision on December 20, 1995 after a review of 43 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.

View all Kodak Clinical Diagnostics, Ltd. devices

FDA 510(k) Submission Details - K955097

510(k) Number K955097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1995
Decision Date December 20, 1995
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 80
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K955097.
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