Cleared Abbreviated

K131645 - INSTANT-VIEW MULTI-DRUG OF ABUSE URINE ...

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

K131645 · Alfa Scientific Designs, Inc. · Toxicology device
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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

Submission Details

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.

Device Classification

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 125
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K131645.
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
K141532 · Guangzhou Wondfo Biotech Co., Ltd. · Jul 2014
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
K133968 · Guangzhou Wondfo Biotech Co., Ltd. · Feb 2014
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131653 · Lin-Zhi International, Inc. · Feb 2014
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
K122961 · Guangzhou Wondfo Biotech Co., Ltd. · Dec 2012
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU
K122904 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2012
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST
K121987 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2012