Cleared Traditional

K883123 - AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT

K883123 is an FDA 510(k) clearance for AMERLIITE FT4 ASSAY LAN.0006/2006 240/1..., manufactured by Amersham Corp.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K883123 · Amersham Corp. · Chemistry device
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Dec 1988
Decision
149d
Days
Class 2
Risk

K883123 is an FDA 510(k) clearance for the AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 149 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 Amersham Corp. devices

FDA 510(k) Submission Details - K883123

510(k) Number K883123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date December 22, 1988
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 88d · This submission: 149d
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 K883123.
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QLIA T UPTAKE ASSAY
K883971 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)
K874875 · Boots-Celltech Diagnostics, Inc. · Mar 1988
DIAGNOSTIC KIT FREE T3 AND FREE T4
K870268 · Sclavo, Inc. · Sep 1987