Cleared Traditional

K951391 - IL TEST DIGOXIN

K951391 is the FDA 510(k) clearance for IL TEST DIGOXIN by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K951391 · Instrumentation Laboratory CO · Toxicology device
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Jun 1995
Decision
74d
Days
Class 2
Risk

K951391 is an FDA 510(k) clearance for the IL TEST DIGOXIN, PN 181761-00. 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 June 9, 1995 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology 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

Submission Details

510(k) Number K951391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date June 09, 1995
Days to Decision 74 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 87d · This submission: 74d
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 Toxicology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 62
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K951391.
DIGOXIN ENZYME IMMUNOASSAY
K963835 · Diagnostic Reagents, Inc. · Dec 1996
AXSYM DIGOXIN II
K953718 · Abbott Laboratories · Sep 1995
IMX DIGOXIN
K952079 · Abbott Laboratories · Jul 1995
DUPONT ACA DIGOXIN (DGN A) METHOD
K951441 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1995
EMIT 2000 DIGOXIN ASSAY
K951755 · Syva Co. · Jun 1995
IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS
K943983 · Instrumentation Laboratory CO · Apr 1995