Cleared Traditional

K790908 - RIA, TEST SET CENTRIA T3

K790908 is an FDA 510(k) clearance for RIA, manufactured by Ventrex Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K790908 · Ventrex Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1979
Decision
44d
Days
Class 2
Risk

K790908 is an FDA 510(k) clearance for the RIA, TEST SET CENTRIA T3. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1979 after a review of 44 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 Ventrex Laboratories, Inc. devices

FDA 510(k) Submission Details - K790908

510(k) Number K790908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1979
Decision Date June 27, 1979
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

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 118
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K790908.
VENTRE/SEP T3 TEST SET
K791588 · Ventrex Laboratories, Inc. · Sep 1979
DAC-CEL T3
K791232 · Burroughs Wellcome Co. · Sep 1979
QUANTIMUNE T-3 FIA
K790960 · Bio-Rad · Aug 1979
CHROMATOGRAPHY TUBES
K790581 · Miles Laboratories, Inc. · May 1979
ORTHO*T-3 RIA (PEG) KIT
K781481 · Ortho Diagnostics, Inc. · Sep 1978
RABBIT ANTIBODY TO HUMAN T3
K781284 · Pcl-Ria, Inc. · Aug 1978