Cleared Special

K110515 - UCP DRUG SCREENING TEST CUPS

K110515 is an FDA 510(k) clearance for UCP DRUG SCREENING TEST CUPS, manufactured by Ucp Biosciences, Inc.. The device is a Class 2 Chemistry device with product code DIS cleared through the Special 510(k) pathway after a 56-day FDA review.

K110515 · Ucp Biosciences, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
56d
Days
Class 2
Risk

K110515 is an FDA 510(k) clearance for the UCP DRUG SCREENING TEST CUPS. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Ucp Biosciences, Inc. (San Jose, US). The FDA issued a Cleared decision on April 20, 2011 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3150 - the FDA in vitro diagnostics and chemistry 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.

FDA 510(k) Submission Details - K110515

510(k) Number K110515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2011
Decision Date April 20, 2011
Days to Decision 56 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 89d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 Chemistry devices follow this clearance model.

Regulatory Peers - DIS Enzyme Immunoassay, Barbiturate

All 99
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K110515 · UCP DRUG SCREENING TEST CUPS
Download PDF FDA Summary Ucp Biosciences, Inc.