Cleared Special

K131811 - UCP COMPACT DRUG TEST CARDS

K131811 is the FDA 510(k) clearance for UCP COMPACT DRUG TEST CARDS by Ucp Biosciences, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K131811 · Ucp Biosciences, Inc. · Toxicology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 87d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K131811.
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K121987 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2012