Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K993986
    Device Name
    SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
    Manufacturer
    SYVA CO.
    Date Cleared
    2000-01-27

    (64 days)

    Product Code
    KXS
    Regulation Number
    862.3630
    Why did this record match?
    Search-Everything :

    Matched: '862.3630'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emit® II Plus Methaqualone Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methaqualone in human urine. The Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Methaqualone Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
    Device Description
    The Syva Emit® II Plus Methaqualone Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of methaqualone in human urine.
    Ask a Question
    K Number
    K955676
    Device Name
    SYNCHRON SYSTEMS METHAQUALONE REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1996-03-04

    (80 days)

    Product Code
    KXS
    Regulation Number
    862.3630
    Why did this record match?
    Search-Everything :

    Matched: '862.3630'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SYNCHRON Systems Methaqualone Reagent, in conjunction with the SYNCHRON System DAT Urine Calibrators, is intended for use in the qualitative determination of Methaqualone in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON CX®4, CX6 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
    Device Description
    The SYNCHRON Methaqualone Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of Methaqualone and it's metabolites in urine. It is designed to complement the current panel of CX Drugs of Abuse Assays, previously cleared by FDA. The kit consists of reagent and calibrators.
    Ask a Question

    Page 1 of 1