Cleared Traditional

KODAK AMERLEX MAB FT3 ASSAY (K922771) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922771 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
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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 33
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K922771.
AXSYM TOTAL T3
K934517 · Abbott Laboratories · Jun 1994
COBAS(R) CORE T3 EIA
K932608 · Roche Diagnostic Systems, Inc. · Dec 1993
VISTA TRIIODOTHYRONINE ASSAY
K923571 · Syva Co. · Oct 1992
MILENIA TOTAL T3
K914467 · Diagnostic Products Corp. · Feb 1992
IMX FREE TRIIODOTHYRONINE
K905261 · Abbott Laboratories · Jan 1991
TDX FREE T3 CALCULATION
K903433 · Abbott Laboratories · Oct 1990