Cleared Traditional

K130463 - UCP HOME DRUG SCREENING TEST

Also marketed or referenced as:
CARDS, CUPS

K130463 is an FDA 510(k) clearance for UCP HOME DRUG SCREENING TEST, manufactured by Ucp Biosciences, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K130463 · Ucp Biosciences, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
82d
Days
Class 2
Risk

K130463 is an FDA 510(k) clearance for the UCP HOME DRUG SCREENING TEST. 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 May 15, 2013 after a review of 82 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ucp Biosciences, Inc. devices

FDA 510(k) Submission Details - K130463

510(k) Number K130463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2013
Decision Date May 15, 2013
Days to Decision 82 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
5d faster than avg
Panel avg: 87d · This submission: 82d
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 K130463.
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K131811 · Ucp Biosciences, Inc. · Jul 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
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
K130811 · Psychemedics Corp. · May 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K123863 · Ucp Biosciences, Inc. · Jan 2013
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
K122961 · Guangzhou Wondfo Biotech Co., Ltd. · Dec 2012