LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980153
    Device Name
    DRUG CHECK
    Manufacturer
    TEXAS IMMUNOLOGY, INC.
    Date Cleared
    1998-03-27

    (70 days)

    Product Code
    DIO,DKZ,DPK,LCM,LDJ
    Regulation Number
    862.3250
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DRUG CHECK is a rapid immunochromatography assay designed for the simultaneous qualatative detection of cocaine, amphetamines, THC, morphine, PCP, and/or their metabolites in urine. It is an in vitro test intended for professional use.

    The DRUG CHECK assay provides only a preliminary analytical test result. A more specific alterate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MC) is the preferred confirmatory method. (1) Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

    Device Description

    Not Found

    AI/ML Overview

    This document is a letter from the FDA regarding clearance for a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. It is a regulatory clearance letter, not a scientific study report.

    Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1