Cleared Abbreviated

INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)

K131645 · Alfa Scientific Designs, Inc. · Toxicology
Oct 2013
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K131645 is an FDA 510(k) clearance for the INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE), a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on October 7, 2013, 124 days after receiving the submission on June 5, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K131645 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2013
Decision Date October 07, 2013
Days to Decision 124 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

Similar Devices — DKZ Enzyme Immunoassay, Amphetamine

All 224
DRI Ecstasy Plus Assay
K240670 · Microgenics Corporation · Oct 2024
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
K233019 · Hangzhou AllTest Biotech Co., Ltd. · Dec 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K231137 · Xenta Biomedical Science Co., Ltd. · May 2023
Quidel Triage? TOX Drug Screen, 94600
K200363 · Quidel Cardiovascular, Inc. · Mar 2020
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K191099 · Atlas Medical · Oct 2019
Quidel Triage TOX Drug Screen, 94600; Quidel Triage? MeterPro
K182719 · Quidel Cardiovascular, Inc. · Jun 2019

More from Alfa Scientific Designs, Inc.

View all
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
K173303 · DKZ · Feb 2018
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212 · KHE · Feb 2018
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
K152122 · DKZ · Jun 2016
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
K100051 · DJG · Jul 2010
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · KHE · Jun 2007