Cleared Traditional

K831064 - PHASE II T3 RADIOIMMUNOASSAY KIT

K831064 is the FDA 510(k) clearance for PHASE II T3 RADIOIMMUNOASSAY KIT by Medical & Scientific Designs, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K831064 · Medical & Scientific Designs, Inc. · Chemistry device
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May 1983
Decision
35d
Days
Class 2
Risk

K831064 is an FDA 510(k) clearance for the PHASE II T3 RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Medical & Scientific Designs, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 35 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 Medical & Scientific Designs, Inc. devices

Submission Details

510(k) Number K831064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1983
Decision Date May 09, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 K831064.
COAT-A-COUNT FREE T3 RIA KIT
K832164 · Diagnostic Products Corp. · Oct 1983
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
T3 DIAGNOSTIC KIT RIA
K821725 · Diagnostic Reagents, Inc. · Jun 1982
T4 DIAGNOSTIC KIT
K820251 · Diagnostic Reagents, Inc. · May 1982