Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL— 510(k) K221198

Clearance details

Applicant

Thermo Fisher Scientific

Product code

Code NGZ

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

2022-04-26

Decision date

2023-03-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oakwood Village, OH, US

• K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL2025-02-27
• K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)2024-06-12
• K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)2024-06-07
• K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL2023-08-31
• K221899 — The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml2023-01-20

• K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL2025-09-25
• K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL2025-09-05
• K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL2025-08-28
• K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL2025-06-30
• K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.2025-06-20