Cleared Traditional

K011673 - ACON AMP ONE STEP AMPHETAMINE TEST STRIP

K011673 is the FDA 510(k) clearance for ACON AMP ONE STEP AMPHETAMINE TEST STRIP by ACON Laboratories, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K011673 · ACON Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
62d
Days
Class 2
Risk

K011673 is an FDA 510(k) clearance for the ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST .... Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on July 31, 2001 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all ACON Laboratories, Inc. devices

Submission Details

510(k) Number K011673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2001
Decision Date July 31, 2001
Days to Decision 62 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
25d faster than avg
Panel avg: 87d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 125
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K011673.
ONTRAK TESTCARD 9
K012396 · Roche Diagnostics Corp. · Nov 2001
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K012110 · Microgenics Corp. · Aug 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · Syva Co. · Aug 2001
AT HOME DRUG TEST, MODEL 9063 T
K010645 · Phamatech · Mar 2001
COBAS INTEGRA AMPHETAMINES
K003865 · Roche Diagnostics Corp. · Feb 2001
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
K994395 · Alfa Scientific Designs, Inc. · Aug 2000