Cleared Traditional

K802470 - T3 RADIOIMMUNOASSAY KIT

K802470 is the FDA 510(k) clearance for T3 RADIOIMMUNOASSAY KIT by American Diagnostic Corp.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K802470 · American Diagnostic Corp. · Chemistry device
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Nov 1980
Decision
34d
Days
Class 2
Risk

K802470 is an FDA 510(k) clearance for the T3 RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 34 days - a notably fast clearance cycle.

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: 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 K802470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1980
Decision Date November 12, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
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 66
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K802470.
COAT-A-COUNT T3 RIA KIT
K812246 · Diagnostic Products Corp. · Aug 1981
TECHNICON STAR SYSTEM T3 RIA METHOD
K810798 · Technicon Instruments Corp. · Apr 1981
T3 RIABEAD DIAGNOSTIC KIT
K803261 · Abbott Laboratories · Jan 1981
SPAC T3 RIA TEST KIT
K801125 · Mallinckrodt Critical Care · Jun 1980
T3 SOLID PHASE RADIOIMMUNOASSAY KIT
K800436 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1980
AMERLEX T-3 RIA KIT
K800374 · Amersham Corp. · Mar 1980