Cleared Traditional

FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST

K052197 · W.H.P.M., Inc. · Toxicology
Jun 2006
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K052197 is an FDA 510(k) clearance for the FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on June 9, 2006, 301 days after receiving the submission on August 12, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K052197 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2005
Decision Date June 09, 2006
Days to Decision 301 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

Similar Devices — DJR Enzyme Immunoassay, Methadone

All 62
LZI Methadone II Enzyme Immunoassay
K192433 · Lin-Zhi International, Inc. · Oct 2019
ARK EDDP Assay
K182779 · ARK Diagnostics, Inc. · Nov 2018
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
K170416 · Lin-Zhi International, Inc. · Jun 2017
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. · Aug 2016
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
K152025 · Assure Tech. Co., Ltd. · Oct 2015
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
K151395 · Immunalysis Corporation · Jul 2015

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