Cleared Special

K151213 - UCP Drug Test Mini Cups

K151213 is an FDA 510(k) clearance for UCP Drug Test Mini Cups, manufactured by Ucp Biosciences, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Special 510(k) pathway after a 107-day FDA review.

K151213 · Ucp Biosciences, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
107d
Days
Class 2
Risk

K151213 is an FDA 510(k) clearance for the UCP Drug Test Mini Cups. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Ucp Biosciences, Inc. (San Jose, US). The FDA issued a Cleared decision on August 21, 2015 after a review of 107 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K151213

510(k) Number K151213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2015
Decision Date August 21, 2015
Days to Decision 107 days
Submission Type Special
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
20d slower than avg
Panel avg: 87d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

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 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K151213.
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
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
Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
K142855 · Omega Laboratories, Inc. · Jul 2015
RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
K141748 · Biophor Diagnostics, Inc. · May 2015
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
K143500 · Immunalysis Corporation · Feb 2015
K151213 · UCP Drug Test Mini Cups
Download PDF FDA Summary Ucp Biosciences, Inc.