Cleared Traditional

ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD (K020313) - FDA 510(k) Clearance

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

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

K020313 · Acon Laboratories Co. · Toxicology device
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Optimized for regulatory review, auditing and printing
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 224
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