Cleared Traditional

K922771 - KODAK AMERLEX MAB FT3 ASSAY

K922771 is the FDA 510(k) clearance for KODAK AMERLEX MAB FT3 ASSAY by Eastman Kodak Company. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K922771 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
127d
Days
Class 2
Risk

K922771 is an FDA 510(k) clearance for the KODAK AMERLEX MAB FT3 ASSAY. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on October 14, 1992 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Eastman Kodak Company devices

Submission Details

510(k) Number K922771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1992
Decision Date October 14, 1992
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 97
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K922771.
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TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
K923258 · Heraeus Kulzer, Inc. · Sep 1992
TOTAL T3 CHEMILUMINESCENCE ASSAY
K923015 · Nichols Institute Diagnostics · Sep 1992
MILENIA TOTAL T3
K914467 · Diagnostic Products Corp. · Feb 1992