Cleared Traditional

K944506 - AXSYM DIGOXIN

K944506 is an FDA 510(k) clearance for AXSYM DIGOXIN, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code KXT cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K944506 · Abbott Laboratories · Microbiology device
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Dec 1994
Decision
96d
Days
Class 2
Risk

K944506 is an FDA 510(k) clearance for the AXSYM DIGOXIN. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.3320 - the FDA microbiology 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K944506

510(k) Number K944506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1994
Decision Date December 19, 1994
Days to Decision 96 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 102d · This submission: 96d
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 Microbiology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 73
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K944506.
EMIT 2000 DIGOXIN ASSAY
K951755 · Syva Co. · Jun 1995
IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS
K943983 · Instrumentation Laboratory CO · Apr 1995
DIGOXIN FLEX(TM) REAGENT CARTRIDGE
K946153 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
EMIT 2000 DIGOXIN ASSAY
K943500 · Syva Co. · Nov 1994
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
K940569 · Sigma Diagnostics, Inc. · Jul 1994
CEDIA DIGOXIN PLUS ASSAY
K941255 · Microgenics Corp. · Jun 1994