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510(k) Data Aggregation

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

    (186 days)

    Product Code
    DIO,DJG,LAT
    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

    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).

    AI/ML Overview

    The provided FDA letter and associated documents for K973986, MECTEST, address the substantial equivalence determination for marketing the device. However, they do not contain the detailed clinical study information needed to describe acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert involvement.

    The document primarily focuses on:

    • The FDA's decision regarding the device's substantial equivalence.
    • Regulatory classifications and requirements.
    • Indications for Use for the MECTEST kit.

    Therefore, I cannot directly answer your request for specific study details from the provided text. The "Indications For Use" section does mention that "MECTEST is highly sensitive and specific," but it does not quantify these metrics or provide the context of a study.

    To provide the information you've requested, I would need access to the full 510(k) submission for K973986, which would include the performance testing data.

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