Cleared Traditional

K821725 - T3 DIAGNOSTIC KIT RIA

K821725 is the FDA 510(k) clearance for T3 DIAGNOSTIC KIT RIA by Diagnostic Reagents, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K821725 · Diagnostic Reagents, Inc. · Chemistry device
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Jun 1982
Decision
16d
Days
Class 2
Risk

K821725 is an FDA 510(k) clearance for the T3 DIAGNOSTIC KIT RIA. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Walker, US). The FDA issued a Cleared decision on June 24, 1982 after a review of 16 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K821725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1982
Decision Date June 24, 1982
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
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 91
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K821725.
CORNING'S MAGIC T3(125I) RADIOIMMUNO-
K832353 · Corning Medical & Scientific · Aug 1983
AMERLEX FREE T-3 RIA KIT
K830980 · Amersham Corp. · May 1983
LEECO T3-RIA DIAGNOSTIC KIT
K830808 · Leeco Diagnostics, Inc. · Apr 1983
T4 DIAGNOSTIC KIT
K820251 · Diagnostic Reagents, Inc. · May 1982
ENZYM-LINKED T3
K820763 · Icl Scientific · Apr 1982
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO
K812611 · Kallestad Laboratories, Inc. · Oct 1981