Cleared Traditional

K914151 - IL TEST(TM DIGOXIN

K914151 is an FDA 510(k) clearance for IL TEST(TM DIGOXIN, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Immunology device with product code KXT cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K914151 · Instrumentation Laboratory CO · Immunology device
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Optimized for regulatory review, auditing and printing
Nov 1991
Decision
74d
Days
Class 2
Risk

K914151 is an FDA 510(k) clearance for the IL TEST(TM DIGOXIN. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 29, 1991 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3320 - the FDA immunology device 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K914151

510(k) Number K914151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date November 29, 1991
Days to Decision 74 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 105d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXT Device Classification - Class 2, Special Controls

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 Immunology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 78
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K914151.
CEDIA DIGOXIN PLUS ASSAY
K923853 · Microgenics Corp. · Sep 1992
CEDIA DIGOXIN ASSAY (MODIFICATION)
K920214 · Microgenics Corp. · Mar 1992
SRI DIGOXIN ENZYME IMMUNOASSAY
K915602 · Serono-Baker Diagnostics, Inc. · Jan 1992
CEDIA(R) DIGOXIN R' ASSAY
K911941 · Microgenics Corp. · May 1991
CEDIA(R) DIGOXIN SC ASSAY
K910642 · Microgenics Corp. · Mar 1991
OPUS(TM) DIGOXIN TEST SYSTEM
K901547 · Pb Diagnostic Systems, Inc. · Jun 1990