Cleared Traditional

K003809 - RAPID DRUGS OF ABUSE SINGLE AND MULTIPL...

K003809 is the FDA 510(k) clearance for RAPID DRUGS OF ABUSE SINGLE AND MULTIPL... by Rapid Diagnostics, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K003809 · Rapid Diagnostics, Inc. · Toxicology device
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Apr 2001
Decision
133d
Days
Class 2
Risk

K003809 is an FDA 510(k) clearance for the RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Rapid Diagnostics, Inc. (Burlingame, US). The FDA issued a Cleared decision on April 20, 2001 after a review of 133 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 Rapid Diagnostics, Inc. devices

Submission Details

510(k) Number K003809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2000
Decision Date April 20, 2001
Days to Decision 133 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
46d slower than avg
Panel avg: 87d · This submission: 133d
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 K003809.
DRI ECSTASY ENZYME IMMUNOASSAY
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