Cleared Traditional

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL

K231433 · Thermo Fisher Scientific · Microbiology
Aug 2023
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K231433 is an FDA 510(k) clearance for the The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL, a Susceptibility Test Plate, Antifungal (Class II — Special Controls, product code NGZ), submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on August 31, 2023, 106 days after receiving the submission on May 17, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K231433 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2023
Decision Date August 31, 2023
Days to Decision 106 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code NGZ — Susceptibility Test Plate, Antifungal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640
Definition 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.

Similar Devices — NGZ Susceptibility Test Plate, Antifungal

All 20
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 ?g/mL
K243738 · Thermo Fisher Scientific · Feb 2025
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 ?g/mL)
K232967 · bioMerieux, Inc. · Jun 2024
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 ?g/mL)
K232963 · bioMerieux, Inc. · Jun 2024
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
K221198 · Thermo Fisher Scientific · Mar 2023
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
K221899 · Thermo Fisher Scientific · Jan 2023
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
K211539 · Thermo Fisher Scientific · Dec 2021

More from Thermo Fisher Scientific

View all
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
K252062 · JWY · Sep 2025
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
K250575 · JWY · Sep 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
K252014 · JWY · Aug 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
K250990 · JWY · Jun 2025
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.
K242843 · JWY · Jun 2025