Cleared Traditional

AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM (K791375) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K791375 · Micromedic Systems · Chemistry device
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Oct 1979
Decision
79d
Days
Class 2
Risk

K791375 is an FDA 510(k) clearance for the AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Micromedic Systems. The FDA issued a Cleared decision on October 11, 1979 after a review of 79 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 Micromedic Systems devices

Submission Details

510(k) Number K791375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1979
Decision Date October 11, 1979
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
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 39
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K791375.
TECHNICON STAR SYSTEM T3 RIA METHOD
K810798 · Technicon Instruments Corp. · Apr 1981
T3 RIABEAD DIAGNOSTIC KIT
K803261 · Abbott Laboratories · Jan 1981
T3 SOLID PHASE RADIOIMMUNOASSAY KIT
K800436 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1980
QUANTIMUNE T-3 FIA
K790960 · Bio-Rad · Aug 1979
CHROMATOGRAPHY TUBES
K790581 · Miles Laboratories, Inc. · May 1979
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
K780787 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1978