Cleared Traditional

AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 (K874362) - FDA 510(k) Clearance

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

K874362 · Amersham Corp. · Chemistry device
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Feb 1988
Decision
118d
Days
Class 2
Risk

K874362 is an FDA 510(k) clearance for the AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - 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

Submission Details

510(k) Number K874362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1987
Decision Date February 18, 1988
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 - KHQ Radioassay, Triiodothyronine Uptake

All 26
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K874362.
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K880619 · Syva Co. · Apr 1988
AFFINITY(TM) I UPTAKE IMMUNIT(TM)
K865083 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1987
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
K860422 · American Dade · Apr 1986
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT
K842694 · Terumo Medical Corp. · Sep 1984