Cleared Traditional

K854971 - V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT

K854971 is the FDA 510(k) clearance for V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT by V-Tech, Inc.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K854971 · V-Tech, Inc. · Chemistry device
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Feb 1986
Decision
57d
Days
Class 2
Risk

K854971 is an FDA 510(k) clearance for the V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on February 6, 1986 after a review of 57 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 V-Tech, Inc. devices

Submission Details

510(k) Number K854971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1985
Decision Date February 06, 1986
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, 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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 58
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K854971.
AFFINITY TOTAL THYROXINE IMMUNIT
K873518 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1987
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
K872192 · Immunotech Corp. · Aug 1987
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)
K862233 · Ciba Corning Diagnostics Corp. · Oct 1986
CEDIA TOTAL T4 ASSAY
K852164 · Microgenics Corp. · Jul 1985
TECHNICON RA-1000 SYS T4-THYROXINE
K841576 · Technicon Instruments Corp. · May 1984
TERUMO SENSIBEAD THYROXINE EIA KIT
K841601 · Terumo Medical Corp. · May 1984