Cleared Traditional

FIRST SIGN DRUG OF ABUSE SCREENING TEST (K032575) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032575 · W.H.P.M., Inc. · Chemistry device
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May 2004
Decision
273d
Days
Class 2
Risk

K032575 is an FDA 510(k) clearance for the FIRST SIGN DRUG OF ABUSE SCREENING TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on May 19, 2004 after a review of 273 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all W.H.P.M., Inc. devices

Submission Details

510(k) Number K032575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2003
Decision Date May 19, 2004
Days to Decision 273 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 88d · This submission: 273d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 78
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K032575.
AMPHETAMINES II
K083764 · Roche Diagnostics Corp. · Feb 2010
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337 · Dade Behring, Inc. · May 2006
EMIT II PLUS ECSTASY ASSAY
K043028 · Dade Behring, Inc. · Jan 2005
RANDOX AMPHETAMINE CLASS ASSAY
K040350 · Randox Laboratories, Ltd. · May 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133 · Dade Behring, Inc. · Apr 2004
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K031004 · Dade Behring, Inc. · Jun 2003