Cleared Abbreviated

K131645 - INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)

K131645 is an FDA 510(k) clearance for INSTANT-VIEW MULTI-DRUG OF ABUSE URINE ..., manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Abbreviated 510(k) pathway after a 124-day FDA review.

K131645 · Alfa Scientific Designs, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
124d
Days
Class 2
Risk

K131645 is an FDA 510(k) clearance for the INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE). Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Powat, US). The FDA issued a Cleared decision on October 7, 2013 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alfa Scientific Designs, Inc. devices

FDA 510(k) Submission Details - K131645

510(k) Number K131645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 87d · This submission: 124d
Pathway characteristics
Standards-based clearance path.

DKZ Device Classification - Class 2, Special Controls

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 184
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K131645.
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131653 · Lin-Zhi International, Inc. · Feb 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP
K131110 · Co-Innovation Biotech Co., Ltd. · Jan 2014
GENPRIME DRUGS OF ABUSE READER SYSTEM
K130082 · Genprime, Inc. · Dec 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K131811 · Ucp Biosciences, Inc. · Jul 2013
Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
K122809 · Advin Biotech · Jun 2013
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
K121065 · Polymed Therapeutics, Inc. · May 2013