Cleared Traditional

K761272 - CENTRIA T4 RIA

K761272 is the FDA 510(k) clearance for CENTRIA T4 RIA by Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K761272 · Clinical Diagnostics, Inc. · Chemistry device
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Mar 1977
Decision
86d
Days
Class 2
Risk

K761272 is an FDA 510(k) clearance for the CENTRIA T4 RIA. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Clinical Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1977 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - the FDA in vitro diagnostics and chemistry 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 Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K761272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1976
Decision Date March 16, 1977
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 Chemistry devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 71
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K761272.
REAGENT SET, T-4, CPB
K770737 · G.D. Searle and Co. · Jun 1977
T-4 RIA REAGENT SET
K770676 · G.D. Searle and Co. · May 1977
THYROSCREEN TM T4 DIAGNOSTIC KIT
K770474 · Abbott Laboratories · Apr 1977
NEONATAL T4 RIA KIT
K770241 · Diagnostic Products Corp. · Feb 1977
SPAC TM T4 RIA KIT
K770156 · Mallinckrodt Critical Care · Feb 1977
DATA-TOPE T4 RIA PROCEDURE
K761282 · Dade, Baxter Travenol Diagnostics, Inc. · Dec 1976