One Step Single/Multi-Drug Test Cup/Dipcard
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140215 FDA 510(k)
- FDA Product Code
- DIS 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 One Step Single/Multi-Drug Test Cup/Dipcard is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Amphetamine, Cocaines, Marijuana, Methamphetamine, Morphine and their metabolites at specific cutoffs. This device is available in two formats: Test Cup and Test Dipcard, with configurations for single drug screening or combinations of multiple drug screening tests.
The test is intended for in vitro diagnostics use in clinical laboratories only and not for point-of-care use. It is a Class II device with FDA 510(k) clearance (K140215) and is regulated under product code DIS. The device is manufactured by Co-Innovation Biotech Co., Ltd. and is not specified as single-use or reusable in the provided data.
Frequently asked questions
What is the One Step Single/Multi-Drug Test Cup/Dipcard used for?
The One Step Single/Multi-Drug Test Cup/Dipcard is a competitive binding, lateral flow immunochromatographic assay designed for the qualitative detection of Amphetamine, Cocaines, Marijuana, Methamphetamine, Morphine and their metabolites at specific cutoffs in clinical laboratory settings only.
What formats are available for this drug test device?
This device is available in two formats: Test Cup and Test Dipcard, with configurations for either single drug screening or combinations of multiple drug screening tests to meet different laboratory testing needs.
Is this device single-use or reusable?
The provided data does not specify whether the One Step Single/Multi-Drug Test Cup/Dipcard is single-use or reusable. Users should consult the manufacturer's instructions for proper handling and disposal information.
What is the regulatory status of this device?
The One Step Single/Multi-Drug Test Cup/Dipcard is a Class II device with FDA 510(k) clearance (K140215) and is regulated under product code DIS. It is intended for in vitro diagnostics use in clinical laboratories only and not for point-of-care use.
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: One Step Single/Multi-drug Test Cup; One Step Single Single/Multi-drug ..., One Step Single/Multi-drug Test Cup/Dipcard, One Step Single/Multi-drug Test Cup; One Step Single Single/Multi-drug ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140215 | Class II | Active |
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Manufacturer
- Manufacturer
- Co-Innovation Biotech Co., Ltd
- FDA Applicant
- Co-Innovation Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K140215 24 fields · synced Sep 25, 2026