Cleared Traditional

K791368 - VENTRE/SEP T4 TEST SET

K791368 is the FDA 510(k) clearance for VENTRE/SEP T4 TEST SET by Ventrex Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K791368 · Ventrex Laboratories, Inc. · Chemistry device
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Sep 1979
Decision
54d
Days
Class 2
Risk

K791368 is an FDA 510(k) clearance for the VENTRE/SEP T4 TEST SET. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K791368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1979
Decision Date September 17, 1979
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - CDX Radioimmunoassay, Total Thyroxine

All 68
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K791368.
AMERLEX T-4 RIA KIT
K800300 · Amersham Corp. · Mar 1980
AMES RIALYZE - CHROMATOGRAPHY TUBES
K800169 · Miles Laboratories, Inc. · Feb 1980
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188 · Abbott Laboratories · Nov 1979
QUANTIMUNE T-4 FIA
K790576 · Bio-Rad · Jul 1979
AUTOPAK TEST DELIVERY SYSTEM
K790907 · Micromedic Systems · Jun 1979
CENTRIA T4 RIA TEST SET
K790800 · Ventrex Laboratories, Inc. · Jun 1979