Cleared Traditional

K150162 - First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (FDA 510(k) Clearance)

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

K150162 · W.H.P.M., Inc. · Chemistry device

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Feb 2015

Decision

31d

Days

Class 2

Risk

K150162 is an FDA 510(k) clearance for the First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on February 26, 2015 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3610 - 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.

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

Submission Details

510(k) Number	K150162 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 26, 2015
Decision Date	February 26, 2015
Days to Decision	31 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

57d faster than avg

Panel avg: 88d · This submission: 31d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	LAF Gas Chromatography, Methamphetamine
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.3610

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.