Cleared Traditional

K171695 - First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana (FDA 510(k) Clearance)

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

K171695 · W.H.P.M., Inc. · Toxicology device

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Feb 2018

Decision

243d

Days

Class 2

Risk

K171695 is an FDA 510(k) clearance for the First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Si.... Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on February 5, 2018 after a review of 243 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 W.H.P.M., Inc. devices

Submission Details

510(k) Number	K171695 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 07, 2017
Decision Date	February 05, 2018
Days to Decision	243 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

156d slower than avg

Panel avg: 87d · This submission: 243d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	NFT Test, Amphetamine, Over The Counter
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.