Cleared Traditional

RIA FOR SERUM THYROXINE (K771415) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K771415 · Clinical Immuno-Diagnostics · Chemistry device
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Jan 1978
Decision
157d
Days
Class 2
Risk

K771415 is an FDA 510(k) clearance for the RIA FOR SERUM THYROXINE. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Clinical Immuno-Diagnostics (Mchenry, US). The FDA issued a Cleared decision on January 5, 1978 after a review of 157 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Immuno-Diagnostics devices

Submission Details

510(k) Number K771415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1977
Decision Date January 05, 1978
Days to Decision 157 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 88d · This submission: 157d
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 27
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K771415.
REAGENTS, MANUEAL, ASSAY, THYROXINE
K780121 · Syva Co. · Mar 1978
ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY
K780219 · Syva Co. · Mar 1978
T4 RIA KIT
K772330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1978
EMIT CENTRIFICHEM THYROXINE ASSAY
K772170 · Syva Co. · Dec 1977
RIA FOR TOTAL THYROXINE
K771309 · Abbott Laboratories · Aug 1977
QUANTIMUNE NEONATAL & THYROXINE RIA
K771135 · Bio-Rad · Jul 1977