Cleared Traditional

K854972 - V-TREND DIG ENZYME IMMUNOASSAY TEST KIT

K854972 is the FDA 510(k) clearance for V-TREND DIG ENZYME IMMUNOASSAY TEST KIT by V-Tech, Inc.. It is a Class 2 Chemistry device (product code KXT) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K854972 · V-Tech, Inc. · Chemistry device
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Jan 1986
Decision
42d
Days
Class 2
Risk

K854972 is an FDA 510(k) clearance for the V-TREND DIG ENZYME IMMUNOASSAY TEST KIT. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on January 22, 1986 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - 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 K854972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1985
Decision Date January 22, 1986
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXT Enzyme Immunoassay, Digoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - KXT Enzyme Immunoassay, Digoxin

All 70
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K854972.
EMIT COLUMN DIGOXIN ASSAY
K861393 · Syva Co. · May 1986
EMIT DIGOXIN MOBILE PHASE SOLUTION
K861394 · Syva Co. · May 1986
CEDIA DIGOXIN ASSAY
K854638 · Microgenics Corp. · Mar 1986
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
K851032 · Roche Diagnostic Systems, Inc. · Apr 1985
DUPONT DIGOXIN ASSAY REAGENTS
K850458 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985
EPSILON DIGOXIN TEST KIT
K842655 · Beckman Instruments, Inc. · Aug 1984