Cleared Traditional

K801843 - T3(125) RADIOIMMUNOASSAY KIT

K801843 is the FDA 510(k) clearance for T3(125) RADIOIMMUNOASSAY KIT by Technia Diagnostics , Ltd.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K801843 · Technia Diagnostics , Ltd. · Chemistry device
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Sep 1980
Decision
46d
Days
Class 2
Risk

K801843 is an FDA 510(k) clearance for the T3(125) RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Technia Diagnostics , Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 46 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 Technia Diagnostics , Ltd. devices

Submission Details

510(k) Number K801843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1980
Decision Date September 16, 1980
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 97
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K801843.
T3 RIABEAD DIAGNOSTIC KIT
K803261 · Abbott Laboratories · Jan 1981
T3-SQUIBB RIA KIT
K802883 · E. R. Squibb & Sons, Inc. · Dec 1980
T3 RADIOIMMUNOASSAY KIT
K802470 · American Diagnostic Corp. · Nov 1980
TRIIODOTHYRONINE RADIOIMMUN. SYSTEM
K801123 · Calbiochem-Behring Corp. · Jun 1980
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