Cleared Traditional

K772122 - T3 RIA KIT

K772122 is the FDA 510(k) clearance for T3 RIA KIT by Antibodies, Inc.. It is a Class 2 Immunology device (product code CDP) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K772122 · Antibodies, Inc. · Immunology device
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Nov 1977
Decision
7d
Days
Class 2
Risk

K772122 is an FDA 510(k) clearance for the T3 RIA KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 17, 1977 after a review of 7 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 Antibodies, Inc. devices

Submission Details

510(k) Number K772122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1977
Decision Date November 17, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 104d · This submission: 7d
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 98
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K772122.
RIA, TEST SET CENTRIA T3
K790908 · Ventrex Laboratories, Inc. · Jun 1979
CHROMATOGRAPHY TUBES
K790581 · Miles Laboratories, Inc. · May 1979
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
K780787 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1978
T3 RIA
K771623 · Hoffmann-La Roche, Inc. · Sep 1977
T3 CLASP RIA KIT
K771142 · E. R. Squibb & Sons, Inc. · Jul 1977
REAGENT, T-3 UPTAKE
K770738 · G.D. Searle and Co. · Jun 1977