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510(k) Data Aggregation

    K Number
    K222613
    Device Name
    ARX Liquid Amies Collection & Transport System
    Manufacturer
    ARX Sciences, Inc.
    Date Cleared
    2024-03-27

    (575 days)

    Product Code
    LIO, JTW, JTX
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARX Sciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, and fastidious bacteria and their transport at 2-8°C or 25-30°C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture.
    Device Description
    The ARX Liquid Amies Collection & Transport System consists of a polypropylene screw-cap vial containing Liquid Amies transport medium and three (3) sterile peel-open pouches containing a pre-scored Microbrush nylon flocked swab for collecting specimens. The three (3) nylon flocked swabs are provided with various score points, tip sizes, and configurations to facilitate specimen collection from various sites on patients' bodies. Nylon flocked swabs facilitate quick absorption and release of clinical specimens. Proper specimen collection from the patient is critical for successful isolation and identification of infectious organisms. Amies liquid medium is a non-nutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, and magnesium chloride to provide essential ions that help maintain osmotic balance and control permeability of bacterial cells. It also contains sodium thioglycolate to provide a reduced environment. ARX Liquid Amies transport medium is capable of maintaining the viability of aerobic, anaerobic, and fastidious bacteria (such as Neisseria gonorrhoeae) during specimen transport to the laboratory for bacteriological testing and culture. All raw materials used in the manufacture of ARX Liquid Amies Collection & Transport System are qualified before use. Every batch of ARX Liquid Amies Collection & Transport System is tested prior to release for sterility, pH, and background count using microscopic examination. Representative samples of each batch are further evaluated for their ability to maintain the viability of selected bacterial agents over predefined time periods.
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    K Number
    K231843
    Device Name
    ARX Viral Transport Media Collection and Transport System
    Manufacturer
    ARX Sciences, Inc.
    Date Cleared
    2024-03-19

    (271 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARX Sciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culture-based media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus.
    Device Description
    ARX Viral Transport Media Collection and Transport System (ARX-VTM) is a specialized systems for collecting and transporting viruses at 2-8 ºC or 20-25 ºC. The ARX-VTM is for use in laboratories to aid in the diagnosis of infections, especially when there is a delay between specimen collection and processing for up to 72 hrs. ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culturebased media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus. Device Specifications: The ARX-VTM contains a non-propagating media supplied in a polypropylene (PP) tube individually with 1 or 3 mL of transport medium and as a kit. The kit contains a PP tube with 1 or 3 mL of transport medium and a sterile peel pouch containing a nylon flocked swab applicator for collecting specimens. Nylon flocked swabs are available in various score points and configurations to facilitate specimen collection from various anatomical sites.
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