INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173303 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 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup is a rapid, qualitative immunoassay device designed for the detection of one or more drugs or metabolites at designated cutoff concentrations in human urine. It utilizes enzyme immunoassay technology and is available in configurations of one to thirteen individual test strips corresponding to the drugs being tested. The device is intended for use in clinical toxicology settings for screening purposes.
The test is supplied as a single-use, non-sterile urine cup incorporating Driven Flow technology for faster and more accurate results. It is designed for point-of-care use and is available in both over-the-counter and prescription versions. The device is not evaluated for MRI safety and should be stored in a dry environment at room temperature. It is authorized under FDA 510(k) clearance with substantially equivalent determination.
Frequently asked questions
What is the INSTANT-VIEW plus Multi-Drug Urine Test Simple Cup used for?
This device is a rapid, qualitative immunoassay designed to screen for one or more drugs or metabolites in human urine at specified cutoff concentrations. It is intended for clinical toxicology settings as a screening tool, not for confirmatory testing.
How is the device supplied and is it sterile?
The test is supplied as a single-use urine cup. It is non-sterile and incorporates Driven Flow technology to facilitate faster and more accurate results. It is designed for point-of-care use.
Can the device be reused or is it single-use?
The device is strictly single-use. It is designed as a disposable urine cup and must not be reused due to the risk of contamination and compromised test integrity.
What configurations are available for this test?
The device is available in configurations ranging from one to thirteen individual test strips, corresponding to the specific drugs being tested. This allows flexibility depending on the screening panel required.
How should the device be stored?
The device should be stored in a dry environment at room temperature. It is not evaluated for MRI safety, so it must be kept away from magnetic resonance imaging environments.
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: Drug Test Urine Cups | Driven Flow Urine Cup - ALFA, Multi Drug Test | Multi Drug Urine Tests | Alfa Scientific, INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173303 | Class II | Active |
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Manufacturer
- Manufacturer
- Alfa Scientific Designs, Inc.
Sources (1)
- FDA 510(k) K173303 24 fields · synced Oct 6, 2026