Cleared Traditional

K771623 - T3 RIA

K771623 is an FDA 510(k) clearance for T3 RIA, manufactured by Hoffmann-La Roche, Inc.. The device is a Class 2 Toxicology device with product code CDP cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K771623 · Hoffmann-La Roche, Inc. · Toxicology device
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Sep 1977
Decision
26d
Days
Class 2
Risk

K771623 is an FDA 510(k) clearance for the T3 RIA. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1977 after a review of 26 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 Hoffmann-La Roche, Inc. devices

FDA 510(k) Submission Details - K771623

510(k) Number K771623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1977
Decision Date September 20, 1977
Days to Decision 26 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
61d faster than avg
Panel avg: 87d · This submission: 26d
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 118
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K771623.
TRIA-PEG RIA DIAG. KIT
K780292 · Nuclear Diagnostics, Inc. · Mar 1978
TRI-TAB-RIA
K772177 · Nuclear Medical Laboratories, Inc. · Dec 1977
IN VITRO T3 RIA TEST
K772108 · Clinical Assays, Inc. · Nov 1977
T3 RIA TEST SYSTEM
K771220 · Monobind · Aug 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