Cleared Traditional

K050540 - UCP RAPID DRUG SCREENING TESTS

K050540 is an FDA 510(k) clearance for UCP RAPID DRUG SCREENING TESTS, 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 58-day FDA review.

K050540 · Ucp Biosciences, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
58d
Days
Class 2
Risk

K050540 is an FDA 510(k) clearance for the UCP RAPID 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 April 29, 2005 after a review of 58 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 - K050540

510(k) Number K050540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date April 29, 2005
Days to Decision 58 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
29d faster than avg
Panel avg: 87d · This submission: 58d
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 K050540.
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS
K051579 · Immunalysis Corporation · Oct 2005
RAPID READER
K041696 · American Bio Medica Corp. · Jul 2005
ON TRAK TESTCARD
K051235 · Varian, Inc. · Jun 2005
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III
K050186 · Ameditech, Inc. · Mar 2005
EMIT II PLUS ECSTASY ASSAY
K043028 · Dade Behring, Inc. · Jan 2005
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
K041822 · ACON Laboratories, Inc. · Sep 2004