Cleared Traditional

K770648 - QUANTIMUNE T-3 RIA

K770648 is the FDA 510(k) clearance for QUANTIMUNE T-3 RIA by Bio-Rad. It is a Class 2 Immunology device (product code CDP) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K770648 · Bio-Rad · Immunology device
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Jun 1977
Decision
70d
Days
Class 2
Risk

K770648 is an FDA 510(k) clearance for the QUANTIMUNE T-3 RIA. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on June 14, 1977 after a review of 70 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 Bio-Rad devices

Submission Details

510(k) Number K770648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1977
Decision Date June 14, 1977
Days to Decision 70 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 104d · This submission: 70d
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 91
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K770648.
T3 RIA
K771623 · Hoffmann-La Roche, Inc. · Sep 1977
REAGENT, T-3 UPTAKE
K770738 · G.D. Searle and Co. · Jun 1977
SERUM SET, THYROID CONTROL
K770739 · G.D. Searle and Co. · 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
T3 RIA (PEG) DIAGNOSTIC KIT
K770201 · Abbott Laboratories · Apr 1977