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510(k) Data Aggregation

    K Number
    K250789
    Device Name
    Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
    Manufacturer
    Thermo Fisher Scientific (Oxoid Ltd.)
    Date Cleared
    2025-06-12

    (90 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Thermo Fisher Scientific (Oxoid Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro. The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is intended to determine susceptibility of Enterobacterales to Aztreonam/Avibactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 demonstrated acceptable performance to determine susceptibility to Aztreonam/Avibactam against the following microorganisms: Enterobacterales (Citrobacter freundii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, and Proteus mirabilis)
    Device Description
    Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
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    K Number
    K243738
    Device Name
    The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2025-02-27

    (85 days)

    Product Code
    NGZ
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Thermo Fisher Scientific

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for micafungin in the dilution range of 0.008-16 ug/mL for testing Candida spp. on The Sensitite YeastOne Susceptibility System. Micafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida guilliermondi Candida krusei Candida parapsilosis Candida tropicalis
    Device Description
    Not Found
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    K Number
    K242021
    Device Name
    The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2024-10-09

    (90 days)

    Product Code
    JWY, LRG, LTT
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Thermo Fisher Scientific

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for meropenem in the dilution range of 0.015 - 32 ug/ml for testing fastidious isolates on the Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Meropenem has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae (penicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes Streptococcus spp. Viridians group Haemophilus influenzae
    Device Description
    Not Found
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    K Number
    K231806
    Device Name
    Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
    Manufacturer
    Oxoid Limited (Part of Thermo Fisher Scientific)
    Date Cleared
    2024-03-22

    (276 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oxoid Limited (Part of Thermo Fisher Scientific)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro. The Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 can be used to determine susceptibility to Rezafungin against the following fungi for which Rezafungin has been shown to be active both clinically and in vitro: Candida albicans Candida glabrata Candida parapsilosis Candida tropicalis
    Device Description
    Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing.
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    K Number
    K232310
    Device Name
    Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2023-10-31

    (90 days)

    Product Code
    JWY, LRG, LTT
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Thermo Fisher Scientific

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensititre 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnositic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Ceftolozane-tazobactam in the dilution range of 0.03/4 - 64/4 µg/ml for testing H. influenzae on the Sensitite 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Ceftolozane-tazobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Haemophilus influenzae
    Device Description
    Not Found
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    K Number
    K232276
    Device Name
    Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
    Manufacturer
    Oxoid Limited (Part of Thermo Fisher Scientific)
    Date Cleared
    2023-10-06

    (67 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oxoid Limited (Part of Thermo Fisher Scientific)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro. The Thermo Scientific Oxoid Sulbactam Disc (10/10 ug) SUD20 can be used to determine susceptibility to Sulbactam/Durlobactam against the following bacteria for which Sulbactam has been shown to be active both clinically and in vitro: Acinetobacter-baumannii calcoaceticus complex
    Device Description
    Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20
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    K Number
    K231433
    Device Name
    The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2023-08-31

    (106 days)

    Product Code
    NGZ
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Thermo Fisher Scientific

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensitite YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candido spp. This 510(k) is for Rezafungin in the dilution range of 0.008 - 8 ug/mL for testing Candida spp. on the Sensititer YeastOne Susceptibility System. Rezafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drup label: Candida albicans Candida glabrata Candida parapsilosis.
    Device Description
    Not Found
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    K Number
    K231988
    Device Name
    Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2023-08-30

    (56 days)

    Product Code
    JWY, LRG, LTT
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Thermo Fisher Scientific

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensitite 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MC or Breakpoint System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for dalbavancin in the dilution range of 0.0005 - 2ug/ml with new FDA breakpoints for testing fastidious Streptococus spp. on the Sensitite 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Dalbavancin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus agalactiae Streptococcus pyogenes Streptococcus anginosus group (S. anginosus, S. constellatus and S. intermedius)
    Device Description
    Not Found
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    K Number
    K231994
    Device Name
    Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2023-08-25

    (51 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Thermo Fisher Scientific

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates. This 510(k) is for Sulbactam in the dilution range of 0.015/4-32/4 ug/mL for testing non-fasidious Gram negative organisms on the Sensititre 18 - 24 hour MIC panel. Sulbactam-durlobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Acinetobacter baumannii-calcoaceticus complex
    Device Description
    Not Found
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    K Number
    K230935
    Device Name
    Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2023-06-30

    (88 days)

    Product Code
    JWY, LRG, LTT
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Thermo Fisher Scientific

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MC or Breakpoint System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Imipenem-relebactam in the dilution range of 0.03/4-128/4 ug/ml for testing fastidious Haemophilus influenzae on the Sensitite 20 - 24 hour Haemophilus influenzae/Streptoccus pneumoniae MIC or Breakpoint Susceptibility System. Imipenem-relebactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Haemophilus influenzae
    Device Description
    Not Found
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