Cleared Traditional

K152590 - ACCU NEWS Drug Screening Test Card/Urin...

K152590 is the FDA 510(k) clearance for ACCU NEWS Drug Screening Test Card/Urin... by Coretests, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K152590 · Coretests, Inc. · Toxicology device
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Apr 2016
Decision
218d
Days
Class 2
Risk

K152590 is an FDA 510(k) clearance for the ACCU NEWS Drug Screening Test Card/Urine Cup. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Coretests, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 15, 2016 after a review of 218 days - an extended review cycle.

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. Standard predicate reliance. 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 Coretests, Inc. devices

Submission Details

510(k) Number K152590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2015
Decision Date April 15, 2016
Days to Decision 218 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 87d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K152590.
QuickScreen Pro Multi Drug Screening Test, Model 9395Z
K181945 · Phamatech, Inc. · Oct 2018
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
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
K152122 · Alfa Scientific Designs, Inc. · Jun 2016
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
K152269 · Healgen Scientific, LLC · Sep 2015
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
K143500 · Immunalysis Corporation · Feb 2015
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
K141532 · Guangzhou Wondfo Biotech Co., Ltd. · Jul 2014