Cleared Traditional

K040133 - URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE

K040133 is an FDA 510(k) clearance for URINE AMPHETAMINE/METHAMPHETAMINE SCREE..., manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code DKZ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K040133 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
78d
Days
Class 2
Risk

K040133 is an FDA 510(k) clearance for the URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on April 8, 2004 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040133

510(k) Number K040133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2004
Decision Date April 08, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K040133.
FIRST SIGN DRUG OF ABUSE SCREENING TEST
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MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
K033566 · Rapid Diagnostics, Inc. · May 2004
RANDOX AMPHETAMINE CLASS ASSAY
K040350 · Randox Laboratories, Ltd. · May 2004
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K040203 · Branan Medical Corp. · Mar 2004
AMEDITECH IMMU TEST DRUG SCREEN PANEL
K040092 · Ameditech, Inc. · Mar 2004
ONTRAK TESTCUP II AND ONSITE CUPKIT
K033902 · Varian, Inc. · Jan 2004
K040133 · URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
Download PDF FDA Summary Dade Behring, Inc.