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CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180255

by Hangzhou Clongene Biotech Co., Ltd.

Identifiers

510(k) Number
K180255 FDA 510(k)
FDA Product Code
PTH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3150 FDA 510(k)
Regulation Number
862.3150 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are lateral flow immunoassays designed for the qualitative detection of multiple drugs and metabolites in human urine. These devices are intended for use in clinical toxicology settings to screen for substances such as amphetamine, benzodiazepines, barbiturates, buprenorphine, cocaine, cotinine, EDDP, fentanyl, ketamine, and others as specified in the test configuration.

The devices are supplied as over-the-counter (OTC) test systems and are classified as Class II medical devices under FDA regulation. They received FDA 510(k) clearance (K180255) on February 28, 2018, based on substantial equivalence to a legally marketed predicate device. The test systems are for single-use application and are to be stored and used according to the manufacturer’s instructions provided in the labeling.

Frequently asked questions

What is the CLUNGENE Multi-Drug Test Dip Card and Easy Cup used for?

These devices are lateral flow immunoassays designed for the qualitative detection of multiple drugs and metabolites in human urine, intended for use in clinical toxicology settings to screen for substances such as amphetamine, benzodiazepines, barbiturates, buprenorphine, cocaine, cotinine, EDDP, fentanyl, ketamine, and others as specified in the test configuration.

How is the CLUNGENE Multi-Drug Test supplied and is it reusable?

The test systems are supplied as over-the-counter (OTC) test systems and are for single-use application only; they are not intended for reuse and must be discarded after each test according to the manufacturer’s instructions.

What regulatory clearance does the CLUNGENE Multi-Drug Test have?

The device received FDA 510(k) clearance (K180255) on February 28, 2018, based on substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device under FDA regulation.

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: Multi-Drug Test - Hangzhou Clongene Biotech Co., Ltd., CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup ..., CLUNGENE Multi-Drug Test Easy Cup - clongene.com, CLUNGENE Multi-Drug Test Dip Card and Easy Cup - Manuals+

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hangzhou Clongene Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K180255 24 fields · synced Oct 6, 2026