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510(k) Data Aggregation

    K Number
    K250956
    Device Name
    HardyDisk AST Gepotidacin 10µg (GEP10)
    Manufacturer
    Hardy Diagnostics
    Date Cleared
    2025-06-26

    (87 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Product Code :

    JTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HardyDisk AST disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae. Use of HardyDisk AST Gepotidacin 10μg (GEP10) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). HardyDisk AST Gepotidacin at concentration 10μg demonstrated acceptable performance to determine the zone diameter (mm) of gepotidacin against the following microorganisms: Enterobacterales (Citrobacter freundii complex, Escherichia coli, Klebsiella pneumoniae, Citrobacter koseri, Klebsiella aerogenes, Klebsiella oxytoca/Raoultella ornithinolytica, Morganella morganii, Proteus mirabilis, Providencia rettgeri) Enterococcus faecalis Staphylococcus saprophyticus
    Device Description
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    K Number
    K250885
    Device Name
    Ceftobiprole BPR 5 µg Disc
    Manufacturer
    Liofilchem Inc.
    Date Cleared
    2025-06-23

    (90 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Product Code :

    JTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liofilchem Antibiotic Discs are a semi-quantitative agar diffusion method for in vitro determination of antimicrobial susceptibility of clinical isolates tested on agar media after overnight incubation. The Ceftobiprole BPR 5 µg Disc is intended to determine susceptibility of Enterobacterales and Staphylococcus aureus to ceftobiprole, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Ceftobiprole at concentrations of 5 μg should be interpreted at 16-18 hours of incubation. The Ceftobiprole BPR 5 µg Disc demonstrated acceptable performance with the following organisms: - Enterobacterales (Escherichia coli and Klebsiella pneumoniae) - Staphylococcus aureus (includes methicillin resistant isolates)
    Device Description
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    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?
    Product Code :

    JTN

    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
    K250454
    Device Name
    HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
    Manufacturer
    Hardy Diagnostics
    Date Cleared
    2025-05-15

    (86 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Product Code :

    JTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae. Use of HardyDisk AST Aztreonam/Avibactam 30/20μg (AZA50) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales to Aztreonam/Avibactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). HardyDisk AST Aztreonam/Avibactam at concentration 30/20μg demonstrated acceptable performance to determine the zone diameter (mm) of Aztreonam/Avibactam against the following microorganisms: Enterobacterales (Citrobacter freundii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, Citrobacter koseri, Enterobacter spp., Klebsiella aerogenes, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Raoultella ornithinolytica, and Serratia spp.)
    Device Description
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    K Number
    K241060
    Device Name
    HardyDisk AST Cefiderocol 30µg (FDC30)
    Manufacturer
    Hardy Diagnostics
    Date Cleared
    2024-07-18

    (91 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Product Code :

    JTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococus spp., Acinetobacter spp., Listeria monocytogenes, Enterocccus spp., and by modified procedures, Candida spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae. Use of HardyDisk™ AST Cefiderocol 30μg (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Cefiderocol. HardyDisk™ AST Cefiderocol at concentration 30μg can be used to determine the zone diameter (mm) of Cefiderocol against the following microorganisms. Active both in vitro and clinical infections against: Gram-negative bacteria Escherichia coli Enterobacter cloacae complex Proteus mirabilis Pseudomonas aeruginosa Acinetobacter baumannii complex Klebsiella pneumoniae Serratia marcescens Active in vitro against: Gram-negative bacteria Citrobacter freundii complex Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri
    Device Description
    HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens.
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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?
    Product Code :

    JTN

    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
    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?
    Product Code :

    JTN

    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
    K231568
    Device Name
    HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
    Manufacturer
    Hardy Diagnostics
    Date Cleared
    2023-07-06

    (36 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Product Code :

    JTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffision test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candidas spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae. Use of HardyDisk™ AST Sulbactam 10/10ug (SUD20) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Sulbactam. HardyDisk™ AST Sulbactam/Durlobactam at concentration 10/10ug can be used to determine the zone diameter (mm) of Sulbactam/Durlobactam against the following microorganisms for which Sulbactam has been shown to be active both clinically and in vitro: Acinetobacter baumannii-calcoaceticus complex (ABC).
    Device Description
    HardyDisk™ AST Sulbactam/Durlobactam 10/10μg (SUD20)
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    K Number
    K230651
    Device Name
    BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2023-06-07

    (90 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Product Code :

    JTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BD BBL Sensi-Disc Antimicrobial Susceptibility Test (AST) Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. BD BBL Sensi-Disc Lefamulin Disc 20 µg (LMU-20) can be used to determine susceptibility to Lefamulin against the following bacteria, as described in the FDA-approved package insert for this antimicrobial agent. Active in vitro and in Clinical Infections Against: Gram-positive Bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates) Gram-negative Bacteria Haemophilus influenzae
    Device Description
    The BD BBL Sensi-Disc Lefamulin 20 µg (LMU-20) device is a 6 mm disc prepared by impregnating high quality absorbent paper with accurately determined amounts of Lefamulin. Discs are clearly marked on both sides with the code LMU-20. The code designates the agent Lefamulin (LMU) and the drug content (20 ug). BD BBL Sensi-Disc Antimicrobial Susceptibility Test Discs are furnished in cartridges containing 50 discs each. The last disc in each cartridge is marked "X" and contains the drug as coded. BD BBL Sensi-Disc Antimicrobial Susceptibility Test Discs can be dispensed using a BD BBL Sensi-Disc Dispenser.
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    K Number
    K230827
    Device Name
    HardyDisk AST Rezafungin 5µg (RZF5)
    Manufacturer
    Hardy Diagnostics
    Date Cleared
    2023-06-01

    (66 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Product Code :

    JTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby- Bauer). Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae. Use of HardyDisk™ AST Rezafungin 5ug (RZF5) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Rezafungin. HardyDisk™ AST Rezafungin at concentration 5ug can be used to determine the zone diameter (mm) of Rezafungin against the following microorganisms for which Rezafungin has been shown to be active both clinically and in vitro. Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalis.
    Device Description
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