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510(k) Data Aggregation

    K Number
    K242976

    Validate with FDA (Live)

    Date Cleared
    2025-11-26

    (426 days)

    Product Code
    Regulation Number
    866.2390
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device is intended to preserve the viability and infectivity of fecal specimens after their collection and during transport from the collection site to the testing laboratory. The product can be used to collect stool specimen directly from the patient, using the swab as a rectal swab. Alternatively, the swab can be used to take material from a previously collected stool specimen. Fecal Transwab® specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.

    Device Description

    Each Fecal Transwab® Liquid Cary Blair Medium Collection and Transport Device comprises a sterile peel pouch containing a plastic screw-cap self standing tube with conical shaped bottom filled with 2 ml of Liquid Cary Blair transport medium and a specimen collection swab with a polyurethane foam coated tip. After sampling the swab applicator is placed in the tube where the bud is bathed in the liquid medium. The swab shaft is broken to allow the swab to fit in the tube, with the screw-cap being replaced.

    Fecal Transwab can also be supplied as a medium only device without a swab, in which case the specimen can be inoculated into the medium using a sterile swab, or scoop, or inoculating loop.

    The Liquid Cary Blair transport medium is a maintenance medium comprising inorganic phosphate buffer, calcium chloride and sodium chloride with a reduced environment due to the presence of sodium thioglycollate. The medium is designed to maintain the viability without overgrowth of enteric bacteria during transit to the testing laboratory.
    The foam-tipped collection swab provided with the Medical Wire Fecal Transwab® Collection and Transport System has a plastic shaft with a defined breakpoint site. A bold red marker line indicates the limit of insertion if the swab is used to take a rectal specimen.

    AI/ML Overview

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