Cleared Traditional

K020313 - ACON ONE STEP MULTI-DRUG MULTI-LINE SCR...

Also marketed or referenced as:
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE

K020313 is the FDA 510(k) clearance for ACON ONE STEP MULTI-DRUG MULTI-LINE SCR... by Acon Laboratories Co.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K020313 · Acon Laboratories Co. · Toxicology device
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May 2002
Decision
98d
Days
Class 2
Risk

K020313 is an FDA 510(k) clearance for the ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Acon Laboratories Co. (San Diego, US). The FDA issued a Cleared decision on May 8, 2002 after a review of 98 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 Acon Laboratories Co. devices

Submission Details

510(k) Number K020313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2002
Decision Date May 08, 2002
Days to Decision 98 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 87d · This submission: 98d
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 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K020313.
INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
K022564 · Alfa Scientific Designs, Inc. · Aug 2002
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
K020395 · Lin-Zhi International, Inc. · Jun 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247 · Biosite Incorporated · Jun 2002
TRIAGE TOX DRUG SCREEN, CATALOG #94000
K012745 · Biosite Incorporated · Jan 2002
ONTRAK TESTCARD 9
K012396 · Roche Diagnostics Corp. · Nov 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · Microgenics Corp. · Aug 2001