Cleared Traditional

K803180 - 1-125 LABELED TRIIODOTHYRONINE(T3)

K803180 is the FDA 510(k) clearance for 1-125 LABELED TRIIODOTHYRONINE(T3) by Pcl-Ria, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K803180 · Pcl-Ria, Inc. · Chemistry device
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Jan 1981
Decision
24d
Days
Class 2
Risk

K803180 is an FDA 510(k) clearance for the 1-125 LABELED TRIIODOTHYRONINE(T3). Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981 after a review of 24 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 Pcl-Ria, Inc. devices

Submission Details

510(k) Number K803180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1980
Decision Date January 09, 1981
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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 100
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K803180.
TECHNICON STAR SYSTEM T3 RIA METHOD
K810798 · Technicon Instruments Corp. · Apr 1981
T3 RIA KIT
K810211 · E. R. Squibb & Sons, Inc. · Feb 1981
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