Cleared Traditional

K011952 - DRUGS OF ABUSE MULTI-TEST STRIP

K011952 is the FDA 510(k) clearance for DRUGS OF ABUSE MULTI-TEST STRIP by Microdiagnostics, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K011952 · Microdiagnostics, Inc. · Toxicology device
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Oct 2001
Decision
126d
Days
Class 2
Risk

K011952 is an FDA 510(k) clearance for the DRUGS OF ABUSE MULTI-TEST STRIP. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Microdiagnostics, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on October 25, 2001 after a review of 126 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 Microdiagnostics, Inc. devices

Submission Details

510(k) Number K011952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2001
Decision Date October 25, 2001
Days to Decision 126 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 87d · This submission: 126d
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 K011952.
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