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510(k) Data Aggregation

    K Number
    K052323
    Device Name
    VERSATREK MYCO PZA KIT
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    2006-01-19

    (147 days)

    Product Code
    MJA, GNW
    Regulation Number
    866.1640
    Why did this record match?
    Product Code :

    MJA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VersaTREK® MYCO PZA KIT is used as a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA). The VersaTREK® MYCO PZA KIT is used with the ESP Culture System II (ESP) and the VersaTREK® Microbial Detection System (VTI).
    Device Description
    The VersaTREK® MYCO PZA susceptibility testing kit is used with the VersaTREK MYCO culture bottle and performed on the ESP Culture System II and on the VersaTREK® Microbial Detection System. The MYCO bottles are supplemented with Myco Growth Supplement and VersaTREK® MYCO PZA reagent and prepared with the appropriate dilution of pyrazinamide as the mechanism for performing the susceptibility test. The VersaTREK® MYCO PZA susceptibility test utilizes a 3 to 15 day testing protocol. A standard suspension of Mycobacterium tuberculosis growth is prepared from a liquid (seed inoculum). 0.5 mL is inoculated into a Growth Control bottle (drug-free), and a bottle containing PZA (both bottles are referred to as an AST set). The test determination is based upon growth of the M. tuberculosis isolate in the Growth Control Bottle compared to the growth in the drug-containing bottle. At the completion of the PZA susceptibility testing protocol, the determination of susceptible or resistant is performed manually by the user, by comparing the time to detection of the Growth Control Bottle to the PZA test bottle.
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    K Number
    K021582
    Device Name
    BACTEC MGIT 960 PZA KIT
    Manufacturer
    BECTON, DICKINSON & CO.
    Date Cleared
    2002-07-13

    (60 days)

    Product Code
    MJA
    Regulation Number
    866.1640
    Why did this record match?
    Product Code :

    MJA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BACTEC® MGIT™ 960 PZA Kit is used as a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to pyrazinamide (PZA). The BACTEC® MGIT™ 960 PZA kit is used with the BACTEC® MGIT™ 960 System.
    Device Description
    The BACTEC® MGIT™ 960 PZA susceptibility test kit is used with the BACTEC® MGIT™ PZA Medium and performed on the BACTEC® MGIT™ 960 System. The PZA Medium tube is supplemented with BACTEC® MGIT™ 960 PZA Supplement and prepared with the appropriate dilution of pyrazinamide as the mechanism for performing the susceptibility test. The BACTEC® MGIT™ 960 PZA susceptibility test utilizes a four to twenty-one day testing protocol. A standardized suspension of Mycobacterium tuberculosis growth is prepared from either solid or liquid culture media. An appropriate dilution is made of this suspension and 0.5 mL is inoculated into a Growth Control tube (drug-free) and a tube containing pyrazinamide (both tubes are referred to as an AST Set). The test interpretation is based on growth of the Mycobacterium tuberculosis isolate in the Growth Control tube compared to the growth in the drug-containing tube. At the completion of the PZA susceptibility testing protocol. the instrument reports a susceptible or resistant result for the Mycobacterium tuberculosis isolate being tested.
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    K Number
    K014123
    Device Name
    BACTEC MGIT 960 SIRE KITS
    Manufacturer
    BECTON, DICKINSON & CO.
    Date Cleared
    2002-04-19

    (123 days)

    Product Code
    MJA
    Regulation Number
    866.1640
    Why did this record match?
    Product Code :

    MJA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BACTEC® MGIT™ 960 SIRE Kit is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin (STR), isoniazid (INH), rifampin (RIF) and ethambutol (EMB). The BACTEC® MGIT™ 960 STR 4.0 Kit and the BACTEC® MGIT™ 960 INH 0.4 Kit are for testing at higher drug concentrations. The BACTEC® MGIT™ 960 SIRE kits are used with the BACTEC® MGIT™ 960 System. The BACTEC® MGIT™ 960 SIRE Kit final test concentrations are 1.0 µg/mL for streptomycin, 0.1 µg/mL for isoniazid, 1.0 µg/mL for rifampin and 5.0 µg/mL for ethambutol. The BACTEC® MGIT™ 960 STR 4.0 Kit final test concentration is 4.0 µg/mL for streptomycin and the BACTEC® MGIT™ 960 INH 0.4 Kit final test concentration is 0.4 µg/mL for isoniazid.
    Device Description
    The BACTEC® MGIT™ 960 SIRE susceptibility test kit is used with the BBL® Mycobacteria Growth Indicator Tube (MGIT™)-7mL on the BACTEC® MGIT™ 960 System. The tube is supplemented with BACTEC® MGIT™ 960 SIRE Supplement enrichment and prepared with the appropriate dilutions of streptomycin, isoniazid, rifampin and ethambutol as the mechanism for performing the susceptibility test. The BACTEC® MGIT™ 960 SIRE test utilizes a four to thirteen day testing protocol. A standardized suspension of Mycobacterium tuberculosis growth, from either solid or broth culture media, is prepared. An appropriate dilution is made of this suspension and 0.5 mL is inoculated into a Growth Control tube (drug-free) and tubes containing streptomycin, isoniazid, rifampin and ethambutol (this is referred to as an AST Set). The test interpretation is based on growth of the Mycobacterium tuberculosis isolate in the Growth Control tube compared to the growth in the drug-containing tubes. At the completion of the susceptibility testing protocol, the instrument reports a susceptible or resistant result for each drug at the concentration(s) being tested.
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    K Number
    K003062
    Device Name
    BACTEC MGIT 960 SIR KITS
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    2001-06-06

    (247 days)

    Product Code
    MJA
    Regulation Number
    866.1640
    Why did this record match?
    Product Code :

    MJA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K972772
    Device Name
    ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    1999-07-13

    (719 days)

    Product Code
    MJA
    Regulation Number
    866.1640
    Why did this record match?
    Product Code :

    MJA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESP Culture System II is an automated system for the detection of microbial growth from blood and other normally sterile body fluids, and for the detection of mycobacteria from various sources. The system may be used for the susceptibility testing of Mycobacterium tuberculosis with the drugs rifampin (1μg/ml), isoniazid ( 0.1 and 0.4ug/ml), and ethambutol (5 and 8ug/ml) The inoculum source for the susceptibility testing can originate from an ESP Myco seed bottle, or a McFarland No. 1 equivalent cell suspension created from colonies grown on an agar source.
    Device Description
    The ESP Culture System II is an automated system for the detection of microbial growth from blood and other normally sterile body fluids, and for the detection of mycobacteria from various sources. The system may be used for the susceptibility testing of Mycobacterium tuberculosis with the drugs rifampin (1μg/ml), isoniazid ( 0.1 and 0.4ug/ml), and ethambutol (5 and 8ug/ml) The inoculum source for the susceptibility testing can originate from an ESP Myco seed bottle, or a McFarland No. 1 equivalent cell suspension created from colonies grown on an agar source.
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