Cleared Traditional

IL TEST DIGOXIN, PN 181761-00 (K951391) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951391 · Instrumentation Laboratory CO · Toxicology device
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Optimized for regulatory review, auditing and printing
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.

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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
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 84
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K951391.
ADVIA Centaur® Digoxin assay
K193397 · Siemens Healthcare Diagnostics, Inc. · Jul 2021
AXSYM DIGOXIN III
K061249 · Abbott Laboratories · Jun 2006
AXSYM DIGOXIN II
K953718 · Abbott Laboratories · Sep 1995
IMX DIGOXIN
K952079 · Abbott Laboratories · Jul 1995
AXSYM DIGOXIN
K944506 · Abbott Laboratories · Dec 1994
TDX (R) DIGOXIN NXT
K882233 · Abbott Laboratories · Jul 1988