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510(k) Data Aggregation

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Copan Italia S.p.A.

    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
    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Copan Italia S.p.A.

    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
    K220052
    Device Name
    Copan FecalSwab Collection, Transport and Preservation System
    Manufacturer
    Copan Italia S.p.A.
    Date Cleared
    2022-12-16

    (344 days)

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

    Copan Italia S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Copan FecalSwab Collection, Transport and Preservation System is intended for collection of viable enteric pathogenic bacteria from rectal swabs and stool specimens during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture. Stool specimens collected with the Copan FecalSwab are also suitable for use with the BD MAX Enteric Bacterial Panel and the BD MAX Extended Enteric Bacterial Panel.
    Device Description
    The FecalSwab Collection. Transport and Preservation System (Copan FecalSwab) is supplied in a collection kit format. Each collection kit consists of a package containing a plastic tube filled with 2 mL of FecalSwab transport and preservation medium and a specimen collection flocked swab intended both for rectal and stool specimen collection. In the laboratory, rectal and stool specimen are processed using standard clinical laboratory operating procedures for culture. The FecalSwab transport and preservation medium is a maintenance medium comprised of: Chloride salts, Sodium salts, Phosphate buffer, L-Cysteine and Agar. The medium is designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory The Copan FecalSwab Collection. Transport and Preservation System was previously cleared (K142094) for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimen are intended be processed using standard clinical laboratory operating procedures for culture but is not cleared for use with downstream molecular assays. The FecalSwab has been demonstrated to be suitable for testing samples with the BD MAX Enteric Bacterial Panel (EBP) and BD MAX Extended Bacterial Panel (xEBP).
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    K Number
    K201849
    Device Name
    eNAT molecular collection and preservation medium
    Manufacturer
    Copan Italia S.p.A.
    Date Cleared
    2020-09-17

    (73 days)

    Product Code
    QBD
    Regulation Number
    866.2950
    Why did this record match?
    Applicant Name (Manufacturer) :

    Copan Italia S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Copan eNAT- molecular collection and preservation medium- is intended for the stabilization, transportation and inactivation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA. eNAT- molecular collection and preservation medium- is intended for use with compatible molecular assays.
    Device Description
    The primary purpose of nucleic acids amplification techniques is to screen for a wide range of infectious diseases, so nucleic acid integrity of clinical specimens during transport and storage should be preserved. eNAT® medium contains a detergent and a protein denaturant to prevent microbial proliferation and to maintains the integrity of the nucleic acids from cells or pathogens collected from patients and inactivates pathogen viability, thus eNAT® is not intended to be used for culture-based techniques. Copan eNAT® has 3 different configurations: Ref. 6U072S: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport medium. Ref. 6U073S01: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport medium and a regular size tip nylon flocked swab for sample collection. Ref. 6U074S01: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport and a minitip nylon flocked swab for sample collection.
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    K Number
    K180052
    Device Name
    UriSwab-Urine Collection, Transport and Preservation System
    Manufacturer
    Copan Italia S.p.A.
    Date Cleared
    2018-03-23

    (74 days)

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

    Copan Italia S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Copan UriSwab™ - 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. UriSwab™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.
    Device Description
    Copan's UriSwab™ - Urine Collection, Transport and Preservation System (UriSwabTM) consists of screw cap self-standing tube with conical shaped bottom. Inside the tube, the cap holds a plastic stick with sponges made of hydrophilic polyurethane. The sponges incorporate preservative substances. Two types of collection systems are available: the regular size (100 mm length X 16 mm diameter) plastic tube and the mini size (80 mm length x 12 mm diameter) plastic tube.
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    K Number
    K142094
    Device Name
    COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
    Manufacturer
    COPAN ITALIA S.P.A.
    Date Cleared
    2015-04-10

    (252 days)

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

    COPAN ITALIA S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Copan FecalSwab Collection, Transport and Preservation System is intended for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture.
    Device Description
    The Copan FecalSwab Collection, Transport and Preservation System (Copan FecalSwab System) is supplied in a sterile collection kit format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 2ml of FecalSwab transport and preservation medium and a specimen collection swab that has a tip flocked with soft nylon fiber. The FecalSwab transport and preservation medium is a maintenance medium comprised of: Chloride salts, Sodium salts, Phosphate buffer, L-Cysteine and Agar. The medium is designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory. The nylon flocked specimen collection swabs provided with the Copan FecalSwab Collection, Transport and Preservation System have a solid plastic shaft with a molded breakpoint site.
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