Cleared Traditional

K802468 - T3 UPTAKE TEST SYSTEM

K802468 is the FDA 510(k) clearance for T3 UPTAKE TEST SYSTEM by American Diagnostic Corp.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K802468 · American Diagnostic Corp. · Chemistry device
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Oct 1980
Decision
22d
Days
Class 2
Risk

K802468 is an FDA 510(k) clearance for the T3 UPTAKE TEST SYSTEM. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 22 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Diagnostic Corp. devices

Submission Details

510(k) Number K802468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1980
Decision Date October 31, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
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 40
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K802468.
ADVANCE TM T-3 UPTAKE ASSAY
K822592 · Syva Co. · Oct 1982
COAT-A-COUNT T3 UPTAKE KIT
K810717 · Diagnostic Products Corp. · Mar 1981
IMMU-TRACE T3 UPTAKE (T3U) REAGENTS
K803044 · American Dade · Jan 1981
ANALYTE T3 UPTAKE
K802246 · Technicon Instruments Corp. · Oct 1980
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY
K800911 · Abbott Laboratories · Jun 1980
VENTRE/SEP T3 UPTAKE RADIOASSAY
K800165 · Ventrex Laboratories, Inc. · Feb 1980