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Multi-Drug Of Abuse Urine Test, Urine Cup Test, Amphetamine Urine Test(cassette…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063545

by Alfa Scientific Designs, Inc.

Identifiers

510(k) Number
K063545 FDA 510(k)
FDA Product Code
DJG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3650 FDA 510(k)
Regulation Number
862.3650 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a rapid qualitative immunoassay for detecting multiple drugs of abuse and their metabolites in human urine specimens. It functions as a cassette or dip-strip test to identify amphetamine, cocaine (benzoylecgonine), and methamphetamine, providing a visual result within minutes. The test is designed for point-of-care use, enabling immediate screening for substance use. It operates via chromatographic separation and immunoassay principles to detect target compounds at specified cutoff concentrations.

The test is supplied as a single-use, non-sterile device intended for use in clinical toxicology settings, including workplace safety and pre-employment screening. It requires no special storage conditions but should be protected from extreme temperatures and moisture. The device is classified as Class II under FDA regulations and has received FDA 510(k) clearance as substantially equivalent to predicate devices. Specimen validity tests (e.g., pH, creatinine) may be included to ensure sample integrity. No MRI safety considerations apply.

Frequently asked questions

What is the Alfa Scientific Amphetamine Urine Test Cassette used for?

This device is a rapid qualitative immunoassay designed to detect amphetamine, cocaine (as benzoylecgonine), and methamphetamine in human urine specimens. It is primarily used for point-of-care screening in clinical toxicology settings, such as workplace safety programs, pre-employment testing, and general substance abuse monitoring. The test provides a visual result within minutes, enabling immediate screening for drug use.

How is the Alfa Scientific Amphetamine Urine Test Cassette supplied and stored?

The test is supplied as a single-use, non-sterile cassette or dip-strip. It does not require special storage conditions, but it should be kept protected from extreme temperatures and moisture to maintain its integrity. No refrigeration or controlled environment is necessary, making it convenient for on-site use.

Is the test reusable, or is it intended for single-use only?

The device is explicitly designed for single-use only. Each cassette or dip-strip is intended to be used once per urine specimen. Reusing the test could compromise accuracy and reliability, as the immunoassay principles and chromatographic separation may be affected by repeated exposure to urine.

Does the test include specimen validity checks?

Yes, the device may include specimen validity tests such as pH or creatinine checks to ensure the urine sample is suitable for accurate testing. These tests help confirm that the specimen is valid and not adulterated, which could otherwise lead to false-negative results.

What regulatory pathway does this device follow?

This device has received FDA 510(k) clearance, meaning it is classified as substantially equivalent to a predicate device under FDA regulations. The clearance was granted through an abbreviated review process, and it falls under the Class II medical device category, which requires special controls to ensure its safety and effectiveness for detecting drugs of abuse in urine.

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 | Multi Drug Urine Tests | Alfa Scientific, Multi-drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test ..., Drug Test, Urine Test, Workplace Safety Test, Rapid Test, Drug ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alfa Scientific Designs, Inc.

Sources (1)

  • FDA 510(k) K063545 24 fields · synced Oct 5, 2026