Cleared Traditional

K790477 - TY RIA KIT

K790477 is the FDA 510(k) clearance for TY RIA KIT by E. R. Squibb & Sons, Inc.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K790477 · E. R. Squibb & Sons, Inc. · Chemistry device
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Apr 1979
Decision
48d
Days
Class 2
Risk

K790477 is an FDA 510(k) clearance for the TY RIA KIT, AUTOMATED ASSAY SYSTEM. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by E. R. Squibb & Sons, Inc. (New York, US). The FDA issued a Cleared decision on April 26, 1979 after a review of 48 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 E. R. Squibb & Sons, Inc. devices

Submission Details

510(k) Number K790477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1979
Decision Date April 26, 1979
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
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 70
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K790477.
AUTOPAK TEST DELIVERY SYSTEM
K790907 · Micromedic Systems · Jun 1979
CENTRIA T4 RIA TEST SET
K790800 · Ventrex Laboratories, Inc. · Jun 1979
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM
K790665 · Micromedic Systems · May 1979
CLINIRIA TOTAL T-4 (RIA) TEST
K781181 · Miles Laboratories, Inc. · Aug 1978
MICRO THYROXINE REAGENT SYSTEM
K781182 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978
EMIT CENTRIFICHEM THYROXINE ASSAY
K780639 · Syva Co. · May 1978