Cleared Traditional

K091588 - UCP HOME DRUG SCREENING TESTS

K091588 is an FDA 510(k) clearance for UCP HOME DRUG SCREENING TESTS, manufactured by Ucp Biosciences, Inc.. The device is a Class 2 Chemistry device with product code DKZ cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K091588 · Ucp Biosciences, Inc. · Chemistry device
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Sep 2009
Decision
94d
Days
Class 2
Risk

K091588 is an FDA 510(k) clearance for the UCP HOME DRUG SCREENING TESTS. 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 September 4, 2009 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ucp Biosciences, Inc. devices

FDA 510(k) Submission Details - K091588

510(k) Number K091588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2009
Decision Date September 04, 2009
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 185
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K091588.
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MEDTOXSCAN
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