Cleared Traditional

First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup

K210327 · W.H.P.M., Inc. · Toxicology

Aug 2021

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K210327 is an FDA 510(k) clearance for the First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup, a Test, Propoxyphene, Over The Counter (Class II — Special Controls, product code QBF), submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on August 12, 2021, 189 days after receiving the submission on February 4, 2021. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3700.

Submission Details

510(k) Number	K210327 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2021
Decision Date	August 12, 2021
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	QBF — Test, Propoxyphene, Over The Counter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3700
Definition	The Propoxyphene Test Is An In Vitro Diagnostic Test For The Qualitative Detection Of Propoxyphene In Human Urine. The Test Is Intended For Over-the-counter Use As The First Step In A Two Step Process To Provide Consumers With Information Concerning The Presence Or Absence Of Propoxyphene In A Urine Sample.