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510(k) Data Aggregation

    K Number
    K242576
    Device Name
    AllTest Viral Transport Medium
    Manufacturer
    Hangzhou Alltest Biotech Co.,Ltd
    Date Cleared
    2025-04-04

    (218 days)

    Product Code
    JSM
    Regulation Number
    866.2390
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AllTest Viral Transport Medium (VTM) is intended for collection and transport of clinical specimens containing viral agents including Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from collection site to the testing laboratory. Specimens collected in the AllTest VTM can be processed using standard clinical laboratory operating procedure for viral culture. The AllTest Viral Transport Medium is also intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing SARS-CoV-2 nucleic acid. The AllTest VTM is suitable for use with compatible legally marketed molecular diagnostic devices.
    Device Description
    The AllTest Viral Transport Medium (VTM) device is comprised of a screw cap polypropylene tube filled with 3 mL VTM. The VTM tube is tightly closed with a polyethylene cap. The AllTest VTM contains Hank's Balanced Buffer solution (HBBS), proteins, sugar, and antimicrobials to provide stability to live viruses. The AllTest VTM also contains a pH indicator (phenol red) to provide a visual check on medium pH. The VTM appears clear and red in color. The packaging also includes a biohazard specimen bag.
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    K Number
    K232565
    Device Name
    UriSponge™
    Manufacturer
    Copan Italia S.p.A.
    Date Cleared
    2024-10-11

    (414 days)

    Product Code
    JSM
    Regulation Number
    866.2390
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Copan UriSponge™ - Urine Collection, Transport, and Preservation System is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, UriSponge™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.
    Device Description
    Copan's UriSponge™ - Urine Collection. Transport, and Preservation System UriSponge™ consists of screw cap self-standing plastic tube with conical shaped bottom. Inside the tube, the cap holds a plastic stick with sponges made of hydrophilic polyurethane. The sponges include preservative substances (Sodium Propionate, and Potassium Sorbate). Two sizes of product are available: the regular tube size (100 mm length X 16 mm diameter) plastic tube and the mini tube size (80 mm length x 12 mm diameter) plastic tube.
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    K Number
    K220908
    Device Name
    Ensol EnTM Specimen Collection and Transport System
    Manufacturer
    Ensol Biosciences Inc.
    Date Cleared
    2024-08-29

    (884 days)

    Product Code
    JSM
    Regulation Number
    866.2390
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ensol EnTM Collection and Transport System is intended for the collection of clinical samples containing upper respiratory viruses including Influenza A, Human Coronavirus 229E, and Respiratory Syncytial Virus (RSV) from the collection site to the testing laboratory to be used with standard diagnostic identification techniques that utilize stable recoverable infectious viral particles.
    Device Description
    The EnTM Collection and Transport System medium consists of a polypropylene conical tube filled with 2 ml of the transport medium (pale brown to red color medium solution), affixed with a polyethylene screw cap. The bottom part of the tube has a self-standing shape. Tubes are provided in a paper rack. The media tubes can be provided with one or two kinds of sterile specimen collection swabs, one for oropharyngeal (OP) oral use and the other nasopharyngeal (NP) for nasal use. The swab shaft is polystyrene with a breaking point, and the swab tip is flocked nylon fibers. The media is provided in two different configurations with and without the sterile peel pouch containing swabs.
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    K Number
    K240235
    Device Name
    OmniTrans Transport System
    Manufacturer
    Shenzhen Dakewe Bio-engineering Co., Ltd.
    Date Cleared
    2024-08-19

    (203 days)

    Product Code
    JSM
    Regulation Number
    866.2390
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OmniTrans™ Transport System is intended for use in the collection of clinical specimens (i.e., sputum, throat/ oropharyngeal swab, whole blood, urine, skin lesion material or exudate) potentially containing viruses, chlamydiae, mycoplasma, or ureaplasma and in their transport from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens.
    Device Description
    OmniTrans™ Transport System includes a screw-cap tube containing transport medium, which can be supplied alone, or in a kit with one of two possible collection swab options in a sterile peel pouch or with two collection swabs in sterile peel pouches. The in-tube-only format contains labeled screw-cap tubes pre-filled with 1 mL, 1.5 mL, or 3 mL of transport medium. The in-kit screw-cap tube format is pre-filled with 1 or 3 mL of transport medium for safe transportation of biological specimens. The format in kit is supplied in pre-packaged collection sets containing one of the two swab types or both of two swab types: Minitip flocking swab with 8 cm breaking point. Regular flocking swab with 3 cm breaking point. A specimen bag, with appropriate biosafety warning labels, is also provided with the device for safe transportation of clinical specimens in the transport medium.
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    K Number
    K233534
    Device Name
    Viral Transport Medium
    Manufacturer
    Hardy Diagnostics
    Date Cleared
    2024-08-02

    (273 days)

    Product Code
    JSM
    Regulation Number
    866.2390
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hardy Diagnostics' Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. Hardy Diagnostics' VTM is a culture-based media that is intended to be used in standard laboratory procedures for virus culture and diagnostic assays that utilize stable recoverable infectious viral particles.
    Device Description
    Hardy Diagnostics' Viral Transport Medium (VTM) is a non-propagating culture-based transport media used for the collection and transport of specimens suspected of containing viruses including Influenza A, Influenza B, Adenovirus, and Echovirus for downstream laboratory test methods. The VTM includes a screw-cap polypropylene tube with skirted conical bottom containing 3mL of transport medium. VTM tubes can be supplied alone, or in a kit format with a mini-tip flocked swab in a sterile peel-pouch. Hardy Diagnostics' VTM is not claimed to be sterile nor is it intended to be sterilized by the end user. Hardy Diagnostics' VTM vials are single use devices. The product is supplied in multiple configurations described in more detail in table 1 below: tubes alone, or in a kit format with a swab.
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    K Number
    K233449
    Device Name
    Avantik VTM
    Manufacturer
    Hanchang Medic Co., Ltd. (Han Chang Medic)
    Date Cleared
    2024-07-15

    (269 days)

    Product Code
    JSM
    Regulation Number
    866.2390
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avantik VTM is intended for the collection and transport of upper respiratory clinical specimens containing respiratory viruses, from the collection site to the testing laboratory. The collection system is a culture-based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles.
    Device Description
    The Avantik VTM is a Non-Propagating Transport Medium Device designed to facilitate the secure collection and transportation of biological samples for diagnosing viral infections. The device contains a transport medium that maintains the viability and infectivity of clinically significant viruses en route to testing laboratories. The device can be stored between 2 - 25°C for up to 12 months and is only for use by Health Care Professionals. Upon collection, samples should be immediately placed in the transport tube to maintain optimal conditions. It is recommended to refrigerate the samples between 2 - 8°C or store them on wet ice to maintain a temperature of 2 - 8°C during transit. Post-collection, the specimen can be transported at 2 - 25°C and should be processed within 48 hours. The transport system allows for specimen collection, maintenance through a buffered medium, and contains a pH indicator. The liquid medium consists of a mixture of Hank's balanced salt solution, BSA (Bovine Serum Albumin), L-cysteine, Gelatin, Sucrose, L-glutamic acid, HEPES, Vancomycin, Amphotericin B, Colistin, and Phenol Red. The liquid medium inhibits the growth of competing bacteria and fungus, is non-toxic to mammalian host cells, and supports viral viability during transportation. The device includes a conical polypropylene vial filled with 3 ml of culture medium, secured with a high-density polyethylene screw-on cap.
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    K Number
    K232454
    Device Name
    Viral Transport Media (VTM)
    Manufacturer
    ALB Luz
    Date Cleared
    2024-05-03

    (263 days)

    Product Code
    JSM
    Regulation Number
    866.2390
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.
    Device Description
    The Viral Transport Medium (VTM) is a non-propagating transport device composed of a culturebased media without swabs. The VTM is designed to preserves upper respiratory samples collected from a patient by placing the sample into the polymer tube containing 3 mL of media. The sample and media are then secured with a leak-proof screwcap for transportation. The VTM maintains cellular integrity and preservation of viruses when properly stored. Prior to use, vials should be stored at 2℃ to 35℃. After specimen collection, the transport tube containing the specimen can be stored for up to 48 hours at either 2-8°C or 20-25°C, for transportation to the laboratory and storage. The medium has been evaluated for storage of the following respiratory viruses, Influenza A, Respiratory Syncytial Virus (RSV), and Rhinovirus, for viral recovery.
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    K Number
    K232357
    Device Name
    Copan Universal Transport Medium (UTM-RT) System
    Manufacturer
    Copan Italia S.p.A.
    Date Cleared
    2024-04-25

    (262 days)

    Product Code
    JSM, LIO
    Regulation Number
    866.2390
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimen containing viruses, chlamydiae, mycoplasma or ureaplasma from the to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture. UTM-RT is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids. UTM-RT is intended for use with compatible molecular assays.
    Device Description
    Copan Universal Transport Medium (UTM-RT®) System is composed of a tube with 3mL of UTM-RT® transport medium, which may be supplied in bulk or as a kit with a sterile specimen collection flocked swab. UTM-RT® medium is designed to maintain viability of viruses, chlamydiae, mycoplasma or ureaplasma during transport from the collection site to the testing laboratory for subsequent culture and to maintain the integrity of respiratory viruses' nucleic acids for testing with a compatible molecular assay.
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    K Number
    K202531
    Device Name
    Azer Scientific Universal Transport Medium
    Manufacturer
    Azer Scientific, Inc.
    Date Cleared
    2024-04-11

    (1318 days)

    Product Code
    JSM
    Regulation Number
    866.2390
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Azer Scientific Universal Transport Medium is for the collection and transport of upper respiratory clinical specimens. containing respiratory viruses from the to the testing laboratory. The Azer Scientific Universal Transport Medium is a culture-based media that can be processed usincal laboratory operating procedures for the isolation and detection of upper respiratory viruses including Influenza A, Respiratory Syncytial Virus (RSV) and Adenovirus.
    Device Description
    The Azer Scientific Universal Transport Medium includes a plastic screw-cap tube with conical bottom containing 3 mL of transport medium and three, 3 mm size glass beads. Azer Scientific Universal Transport Medium tubes can be supplied alone or in a kit format with one of three different collection swab options in a sterile peel pouch.
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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
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    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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