Cleared Special

K131811 - UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS

K131811 is an FDA 510(k) clearance for UCP COMPACT DRUG TEST CARDS, 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 30-day FDA review.

K131811 · Ucp Biosciences, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
30d
Days
Class 2
Risk

K131811 is an FDA 510(k) clearance for the UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST 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 July 19, 2013 after a review of 30 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ucp Biosciences, Inc. devices

FDA 510(k) Submission Details - K131811

510(k) Number K131811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2013
Decision Date July 19, 2013
Days to Decision 30 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 87d · This submission: 30d
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 184
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K131811.
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
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645 · Alfa Scientific Designs, Inc. · Oct 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
UCP HOME DRUG SCREENING TEST
K130463 · Ucp Biosciences, Inc. · May 2013