Cleared Traditional

REAGENT, T-3 UPTAKE (K770738) - FDA 510(k) Clearance

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

K770738 · G.D. Searle and Co. · Immunology device
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Jun 1977
Decision
62d
Days
Class 2
Risk

K770738 is an FDA 510(k) clearance for the REAGENT, T-3 UPTAKE. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1977 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1710 - the FDA immunology 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 G.D. Searle and Co. devices

Submission Details

510(k) Number K770738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1977
Decision Date June 22, 1977
Days to Decision 62 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 104d · This submission: 62d
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 Immunology 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 K770738.
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
QUANTIMUNE T-3 RIA
K770648 · Bio-Rad · Jun 1977
T3 RIA (PEG) DIAGNOSTIC KIT
K770201 · Abbott Laboratories · Apr 1977