Cleared Traditional

K943983 - IL TEST DIGOXIN & IL TEST DIGOXIN CALIB...

K943983 is the FDA 510(k) clearance for IL TEST DIGOXIN & IL TEST DIGOXIN CALIB... by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K943983 · Instrumentation Laboratory CO · Toxicology device
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Apr 1995
Decision
307d
Days
Class 2
Risk

K943983 is an FDA 510(k) clearance for the IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS. 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 April 10, 1995 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K943983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date April 10, 1995
Days to Decision 307 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
220d slower than avg
Panel avg: 87d · This submission: 307d
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 61
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K943983.
IL TEST DIGOXIN, PN 181761-00
K951391 · Instrumentation Laboratory CO · Jun 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
DIGOXIN FLEX(TM) REAGENT CARTRIDGE
K946153 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
AXSYM DIGOXIN
K944506 · Abbott Laboratories · Dec 1994
EMIT 2000 DIGOXIN ASSAY
K943500 · Syva Co. · Nov 1994