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Instant-View Morphine (2000) Urine Cassette Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K010080

by Alfa Scientific Designs, Inc.

Identifiers

510(k) Number
K010080 FDA 510(k)
FDA Product Code
DOE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3640 FDA 510(k)
Regulation Number
862.3640 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Instant-View Morphine (2000) Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is classified as a Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. under regulation number 862.3640 and falls within the medical specialty of Clinical Toxicology.

The device received FDA 510(k) clearance under K010080 on May 29, 2001, following a traditional submission process. It is supplied as a cassette test format for point-of-care use in clinical toxicology settings. The device is intended for in vitro diagnostic use with human urine specimens and is not indicated for any other specimen type or use beyond morphine detection at the specified cutoff.

Frequently asked questions

What is the Instant-View Morphine (2000) Urine Cassette Test used for?

It is intended to detect morphine only in human urine at a cutoff level of 300 ng/ml using a qualitative one-step lateral flow competitive binding immunoassay, designed for in vitro diagnostic use in clinical toxicology settings.

How is the Instant-View Morphine (2000) Urine Cassette Test supplied and used?

It is supplied as a cassette test format for point-of-care use, requiring human urine specimens and intended for in vitro diagnostic use only, with no indication for other specimen types or uses beyond morphine detection at the specified cutoff.

Is the Instant-View Morphine (2000) Urine Cassette Test reusable or single-use?

As a point-of-care cassette test for in vitro diagnostic use, it is designed for single-use application with human urine specimens and is not indicated for reuse, ensuring test integrity and preventing cross-contamination.

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: Instant-view Morphine (2000) Urine Cassette Test, INSTANT-VIEW MORPHINE URINE CASSETTE TEST (K994404) — FDA 510(k ..., Opiate Drug Test | Buy Morphine Drug Tests | Alfa Scientific, Multi Drug Test | Multi Drug Urine Tests | Alfa Scientific, Instant-view - Drugs of Abuse Test Single Drug Morphine (MOP) Urine ...

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) K010080 24 fields · synced Oct 1, 2026