Cleared Traditional

K922713 - KODAK AMERLITE MAB FT3 ASSAY

K922713 is an FDA 510(k) clearance for KODAK AMERLITE MAB FT3 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 143-day FDA review.

K922713 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
143d
Days
Class 2
Risk

K922713 is an FDA 510(k) clearance for the KODAK AMERLITE MAB FT3 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 October 26, 1992 after a review of 143 days - within the typical 510(k) review window.

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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K922713

510(k) Number K922713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1992
Decision Date October 26, 1992
Days to Decision 143 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
55d slower than avg
Panel avg: 88d · This submission: 143d
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 79
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K922713.
ACCESS(R) FREE T4 ASSAY
K925913 · Bio-Rad Laboratories, Inc. · Jan 1993
VIDAS FREE THYROXINE(FT4) ASSAY
K925177 · Biomerieux Vitek, Inc. · Nov 1992
VISTA FREE THYROXINE ASSAY
K923572 · Syva Co. · Nov 1992
AMERLITE MAB FT4 ASSAY
K920247 · Eastman Kodak Company · Mar 1992
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