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510(k) Data Aggregation
K Number
K250789Device 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
866.1620Why 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
K243738Device 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
866.1640Why 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
K242021Device 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
866.1640Why 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
K231806Device 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
866.1620Why 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
K232310Device 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
866.1640Why 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
K232276Device 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
866.1620Why 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
K231433Device 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
866.1640Why 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
K231988Device 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
866.1640Why 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
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K Number
K231994Device 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
866.1640Why 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
K230935Device 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
866.1640Why 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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