Cleared Traditional

First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)

K160793 · W.H.P.M., Inc. · Toxicology
Aug 2016
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K160793 is an FDA 510(k) clearance for the First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline), a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on August 17, 2016, 147 days after receiving the submission on March 23, 2016. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K160793 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2016
Decision Date August 17, 2016
Days to Decision 147 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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