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Ucp Compact Drug Tests

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152908

by Ucp Biosciences, Inc.

Identifiers

510(k) Number
K152908 FDA 510(k)
FDA Product Code
DKZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3100 FDA 510(k)
Regulation Number
862.3100 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ucp Compact Drug Tests are lateral flow immunochromatographic assays designed for the qualitative detection of drugs of abuse and their metabolites in human urine. These devices utilize a competitive binding principle where the drug present in the sample competes with a drug-conjugate for limited antibody binding sites.

This device is supplied as a rapid, qualitative immunoassay in the form of test cards or cups. It is classified as a Class II medical device under clinical toxicology and has received FDA 510(k) clearance.

Frequently asked questions

What is the intended use of UCP Compact Drug Tests?

These devices are intended for the qualitative detection of drugs of abuse and their metabolites in human urine samples. They function as lateral flow immunochromatographic assays to identify the presence of specific substances.

How do these drug tests work?

The tests utilize a competitive binding principle. In this process, any drug present in the urine sample competes with a drug-conjugate for a limited number of antibody binding sites on the test device.

In what formats are these tests supplied?

UCP Compact Drug Tests are supplied as rapid, qualitative immunoassays in the form of either test cards or test cups.

What is the regulatory status of this device?

The UCP Compact Drug Tests are classified as Class II medical devices under clinical toxicology and have received FDA 510(k) clearance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K123863 FDA 510 (k) - UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TESTS (K152908) — FDA 510 (k) | Innolitics, Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups, UCP Compact Drug Test Cards — FDA Class II Medical Device | MedEquip ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ucp Biosciences, Inc.

Sources (1)

  • FDA 510(k) K152908 24 fields · synced Sep 23, 2026