Cleared Traditional

K770201 - T3 RIA (PEG) DIAGNOSTIC KIT

K770201 is an FDA 510(k) clearance for T3 RIA (PEG) DIAGNOSTIC KIT, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code CDP cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K770201 · Abbott Laboratories · Toxicology device
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Apr 1977
Decision
64d
Days
Class 2
Risk

K770201 is an FDA 510(k) clearance for the T3 RIA (PEG) DIAGNOSTIC KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1710 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K770201

510(k) Number K770201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1977
Decision Date April 05, 1977
Days to Decision 64 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
23d faster than avg
Panel avg: 87d · This submission: 64d
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 Toxicology devices follow this clearance model.

Regulatory Peers - CDP Radioimmunoassay, Total Triiodothyronine

All 104
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K770201.
QUANTIMUNE T-3 RIA
K770648 · Bio-Rad · Jun 1977
RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3
K770520 · Kallestad Laboratories, Inc. · Jun 1977
T-3 RIA REAGENT SET
K770677 · G.D. Searle and Co. · May 1977
CENTRIA T3 RIA
K761305 · Union Carbide Corp. · Dec 1976
TEST, RIA, TRIODOTHYRONINE
K760057 · Smithkline Diagnostics, Inc. · Sep 1976