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510(k) Data Aggregation

    K Number
    K973986
    Device Name
    MECTEST
    Manufacturer
    Date Cleared
    1998-04-24

    (186 days)

    Product Code
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECO INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MECTEST is a kit for the processing and semiquantitative analysis of meconium for cocaine, opiate and cannabinoid by radioimmunoassay and for the processing and semiquantitative analysis of cocaine and opiate by enzyme immunoassay (EMIT) and by fluorescence polarization (FPIA). MECTEST is for hospital and laboratory use only. MECTEST is an in vitro diagnostic device intended to prospectively screen and identify newborn infants exposed to drugs (cocaine, opiate and cannabinoid) in utero. Meconium drug testing via MECTEST is an idea and important diagnostic tool for clinical and research applications. MECTEST offers a positive alternative to urine analysis because (1) it is highly sensitive and specific, (2) the test can be performed using commong laboratory techniques for purposes of mass screening with capabilities of GC/MS confirmation, (3) collection of meconium is easy and non invasive, (4) analysis of serial meconium can reflect the type, chronology and amount of in utero drug exposure of the infant, and, (5) drugs in meconium are present up to the third day after birth; thus late testing of the infant for drugs is possible.
    Device Description
    MECTEST is a kit for the processing and semiquantitative analysis of meconium for cocaine, opiate and cannabinoid by radioimmunoassay and for the processing and semiquantitative analysis of cocaine and opiate by enzyme immunoassay (EMIT) and by fluorescence polarization (FPIA).
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