One Step Single/Multi-Drug Test Cup +1 more model
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131110 FDA 510(k)
- FDA Product Code
- DKZ FDA 510(k)
- Models / Variants
- One Step Single/Multi-Drug Test Cup 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)
This device is a lateral flow immunochromatographic assay for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine and their metabolites in urine samples at specified cutoffs. It operates on a competitive binding principle to provide rapid screening results for multiple drugs simultaneously.
The test is supplied as a single-use, ready-to-use cup or dipcard format and is intended for in vitro diagnostic use. It is not described as sterile or reusable, and no MRI safety information is provided in the data. Storage conditions and specific handling instructions are not detailed in the available specifications.
Frequently asked questions
What is this device used for?
This device is a lateral flow immunochromatographic assay designed for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, and their metabolites in urine samples at specified cutoffs. It provides rapid screening results for multiple drugs simultaneously.
How is the device supplied?
The device is supplied in two formats: a ready-to-use cup and a ready-to-use dipcard. Both are designed for single-use and are intended for in vitro diagnostic use only.
Is the device sterile and can it be reused?
The device is not described as sterile in the available specifications, and it is explicitly intended for single-use only. There is no information indicating that it can be cleaned or reused.
What are the storage and handling requirements?
The available specifications do not detail specific storage conditions or handling instructions. Users should refer to the manufacturer's labeling or package insert for guidance on proper storage and handling prior to use.
What regulatory route was used for this device?
This device was authorized through the FDA 510(k) premarket notification process. The clearance type is Traditional, and the decision description indicates it was found substantially equivalent to a predicate device. The advisory committee involved was Clinical Toxicology.
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: Rapid Response® Multi-Drug One Step Cup | BTNX Inc, One Step Single/Multi-drug Test Cup; One Step Single Single/Multi-drug ..., One Step Single/Multi-drug Test Cup, One Step Single/Multi-drug Test ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131110 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Co-Innovation Biotech Co., Ltd
- FDA Applicant
- Co-Innovation Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K131110 24 fields · synced Sep 24, 2026