Cleared Traditional

K790800 - CENTRIA T4 RIA TEST SET

K790800 is an FDA 510(k) clearance for CENTRIA T4 RIA TEST SET, manufactured by Ventrex Laboratories, Inc.. The device is a Class 2 Toxicology device with product code CDX cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K790800 · Ventrex Laboratories, Inc. · Toxicology device
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Jun 1979
Decision
52d
Days
Class 2
Risk

K790800 is an FDA 510(k) clearance for the CENTRIA T4 RIA 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 June 15, 1979 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1700 - the FDA toxicology device 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

FDA 510(k) Submission Details - K790800

510(k) Number K790800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1979
Decision Date June 15, 1979
Days to Decision 52 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 87d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 93
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K790800.
DAC-CEL T4
K791231 · Burroughs Wellcome Co. · Sep 1979
QUANTIMUNE T-4 FIA
K790576 · Bio-Rad · Jul 1979
AUTOPAK TEST DELIVERY SYSTEM
K790907 · Micromedic Systems · Jun 1979
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM
K790665 · Micromedic Systems · May 1979
TY RIA KIT, AUTOMATED ASSAY SYSTEM
K790477 · E. R. Squibb & Sons, Inc. · Apr 1979
RIA KIT, GAMMACOAT
K782109 · Clinical Assays, Inc. · Jan 1979