Cleared Traditional

K152122 - Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

K152122 is an FDA 510(k) clearance for Instant-View Multi-Drug Urine Test Cup ..., manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K152122 · Alfa Scientific Designs, Inc. · Toxicology device
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Jun 2016
Decision
330d
Days
Class 2
Risk

K152122 is an FDA 510(k) clearance for the Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Ur.... 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 June 24, 2016 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alfa Scientific Designs, Inc. devices

FDA 510(k) Submission Details - K152122

510(k) Number K152122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2015
Decision Date June 24, 2016
Days to Decision 330 days
Submission Type Traditional
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
243d slower than avg
Panel avg: 87d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K152122.
QuickScreen Pro Multi Drug Screening Test, Model 9395Z
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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 · Alfa Scientific Designs, Inc. · Feb 2018
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
K161251 · Hangzhou Clongene Biotech Co., Ltd. · Aug 2016
UCP COMPACT DRUG TESTS
K152908 · Ucp Biosciences, Inc. · May 2016
ACCU NEWS Drug Screening Test Card/Urine Cup
K152590 · Coretests, Inc. · Apr 2016
AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
K153465 · Assure Tech. (Hangzhou) Co, Ltd. · Mar 2016