Cleared Traditional

AXSYM DIGOXIN (K944506) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 Microbiology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 46
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
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135 · Syva Co. · Apr 1994