Cleared Traditional

K953115 - AXSYM AMPHETAMINE/METHAMPHETAMINE II

K953115 is an FDA 510(k) clearance for AXSYM AMPHETAMINE/METHAMPHETAMINE II, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K953115 · Abbott Laboratories · Toxicology device
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Oct 1995
Decision
95d
Days
Class 2
Risk

K953115 is an FDA 510(k) clearance for the AXSYM AMPHETAMINE/METHAMPHETAMINE II. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K953115

510(k) Number K953115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date October 06, 1995
Days to Decision 95 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
8d slower than avg
Panel avg: 87d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 140
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K953115.
ONTRAK TESTCUP AMPHETAMINES
K962411 · Roche Diagnostic Systems, Inc. · Oct 1996
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000
K955934 · Biosite Incorporated · Feb 1996
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS
K955935 · Biosite Incorporated · Feb 1996
AMPHETAMINES MICRO-PLATE EIA
K935573 · Solarcare Technologies Corp,Inc. · Jul 1995
CEDIA DAU AMPHETAMINES ASSAY
K951154 · Microgenics Corp. · May 1995
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
K945610 · Princeton BioMeditech Corp. · Apr 1995