Cleared Traditional

K813465 - FREE T4 RIA TEST SET

K813465 is the FDA 510(k) clearance for FREE T4 RIA TEST SET by Ventrex Laboratories, Inc.. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K813465 · Ventrex Laboratories, Inc. · Chemistry device

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Dec 1981

Decision

20d

Days

Class 2

Risk

K813465 is an FDA 510(k) clearance for the FREE T4 RIA TEST SET. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number	K813465 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 11, 1981
Decision Date	December 31, 1981
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

68d faster than avg

Panel avg: 88d · This submission: 20d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CEC Radioimmunoassay, Free Thyroxine
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1695

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 - CEC Radioimmunoassay, Free Thyroxine

All 64

Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K813465.

THYROXINE ANALYSIS PRODUCTS/RADIO-FREE

K823264 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1983

SINGLE STEP FREE-T4 125I RADIOIMMUNO-

K823144 · Corning Medical & Scientific · Nov 1982

COAT-A-COUNT FREE THYROXINE KIT/COMPONEN

K822882 · Diagnostic Products Corp. · Nov 1982

CODE IM 2050 AMERLEX FREE T4 RIA KIT

K810231 · Amersham Corp. · Feb 1981

IMMO PHASE FT4 ASSAY

K772194 · Corning Medical & Scientific · Jan 1978

TRIOBEAD-125 DIAGNOSTIC KIT

K771236 · Abbott Laboratories · Aug 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K813465

Ventrex Laboratories, Inc.

Mchenry, IL · US

Regulatory profile

82 submissions 82 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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