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510(k) K243738

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL by Thermo Fisher Scientific — Product Code NGZ

K243738 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL". The FDA issued a decision of Substantially Equivalent on February 27, 2025. The device falls under product code NGZ (Susceptibility Test Plate, Antifungal), a Class II device regulated under 21 CFR 866.1640. Thermo Fisher Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2025
Date Received
December 4, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Plate, Antifungal
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.

Other clearances by Thermo Fisher Scientific

  • K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin (September 25, 2025)
  • K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreon (September 5, 2025)
  • K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin (August 28, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox (June 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (June 20, 2025)
  • K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomyci (May 22, 2025)
  • K242658 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxa (April 15, 2025)
  • K242905 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (February 10, 2025)
  • K243201 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (February 10, 2025)
  • K243169 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobipr (December 19, 2024)

Other clearances for product code NGZ

  • K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (June 12, 2024)
  • K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (June 7, 2024)
  • K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution ra (August 31, 2023)
  • K221198 — Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range (March 10, 2023)
  • K221899 — The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution r (January 20, 2023)
  • K211539 — Sensititre YeastOne Susceptibility System with Voriconazole in the dilution rang (December 15, 2021)
  • K181368 — VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) (June 20, 2018)
  • K151923 — VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (March 25, 2016)
  • K151817 — VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL (February 18, 2016)
  • K133952 — VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE (August 19, 2014)

FDA data resources