Cleared Traditional

K033566 - MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062

K033566 is an FDA 510(k) clearance for MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), manufactured by Rapid Diagnostics, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K033566

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.

DKZ Device Classification - Class 2, Special Controls

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 186
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K033566.
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ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
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RANDOX AMPHETAMINE CLASS ASSAY
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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