Cleared Traditional

K033566 - MICROMEDIC DRUGS OF ABUSE PANEL TEST (9)

K033566 is the FDA 510(k) clearance for MICROMEDIC DRUGS OF ABUSE PANEL TEST (9) by Rapid Diagnostics, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K033566 · Rapid Diagnostics, Inc. · Toxicology device
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May 2004
Decision
187d
Days
Class 2
Risk

K033566 is an FDA 510(k) clearance for the MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Rapid Diagnostics, Inc. (Northridge, US). The FDA issued a Cleared decision on May 17, 2004 after a review of 187 days - an extended review 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: 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 Rapid Diagnostics, Inc. devices

Submission Details

510(k) Number K033566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2003
Decision Date May 17, 2004
Days to Decision 187 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
100d slower than avg
Panel avg: 87d · This submission: 187d
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 K033566.
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
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ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
K041685 · ACON Laboratories, Inc. · Aug 2004
RANDOX AMPHETAMINE CLASS ASSAY
K040350 · Randox Laboratories, Ltd. · May 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133 · Dade Behring, Inc. · Apr 2004
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
K033094 · Lin-Zhi International, Inc. · Dec 2003