Cleared Traditional

First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test

K142353 · W.H.P.M., Inc. · Toxicology
Oct 2014
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K142353 is an FDA 510(k) clearance for the First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on October 7, 2014, 47 days after receiving the submission on August 21, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K142353 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2014
Decision Date October 07, 2014
Days to Decision 47 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

Similar Devices — DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 144
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
K213211 · Carolina Liquid Chemistries Corp. · Jan 2022
DRI Cocaine Metabolite Assay
K211973 · Microgenics Corporation · Sep 2021
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
K191638 · Medtest DX · Mar 2020
DRI Cocaine Metabolite Assay
K181499 · Microgenics Corporation · Jul 2018
Emit II Plus Cocaine Metabolite Assay
K170293 · Siemens Healthcare Diagnostics, Inc. · Oct 2017
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
K163570 · Carolina Liquid Chemistries Corporation · Aug 2017

More from W.H.P.M., Inc.

View all
Hemosure Accu-Reader A100
K200754 · OOX · Jun 2022
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 · QBF · Aug 2021
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
K171695 · NFT · Feb 2018
First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
K160793 · DJR · Aug 2016
First Sign? Drug of Abuse Buprenorphine Cup Test, First Sign? Drug of Abuse Buprenorphine Dip Card Test, First Sign? Drug of Abuse Butalbital Cup Test, First Sign? Drug of Abuse Butalbital Dip Card Test, First Sign? Drug of Abuse Morphine Cup Test, First Sign? Drug of Abuse Morphine Dip Card Test.
K152551 · DJG · Nov 2015