The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
FDA 510(k) K243738 · Thermo Fisher Scientific
510(k) numberK243738
Submission
- Device name
- The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
- Applicant
- Thermo Fisher Scientific
Oakwood Village, OH, US - Received
- December 4, 2024
- Decision date
- February 27, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NGZ – Susceptibility Test Plate, Antifungal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
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 510(k)s with product code NGZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)NGZ · Traditional | bioMerieux, Inc. | 06/12/2024SE |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)NGZ · Traditional | bioMerieux, Inc. | 06/07/2024SE |
| K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of…NGZ · Traditional | Thermo Fisher Scientific | 08/31/2023SE |
| K221198 | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of…NGZ · Traditional | Thermo Fisher Scientific | 03/10/2023SE |
| K221899 | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of…NGZ · Traditional | Thermo Fisher Scientific | 01/20/2023SE |
| K211539 | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of…NGZ · Traditional | Thermo Fisher Scientific | 12/15/2021SE |
| K181368 | VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)NGZ · Special | bioMerieux, Inc. | 06/20/2018SE |
| K151923 | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)NGZ · Traditional | bioMerieux, Inc. | 03/25/2016SE |
| K151817 | VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLNGZ · Traditional | bioMerieux, Inc. | 02/18/2016SE |
| K133952 | Vitek 2 Ast Ys Flucytosine, Vitek 2 Ast Yeast FlucytosineNGZ · Traditional | bioMerieux, Inc. | 08/19/2014SE |
More from bioMerieux, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the…JWY · Traditional | 09/25/2025SE |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with…JWY · Traditional | 09/05/2025SE |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the…JWY · Traditional | 08/28/2025SE |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in…JWY · Traditional | 06/30/2025SE |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional | 06/20/2025SE |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the…JWY · Traditional | 05/22/2025SE |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in…JWY · Traditional | 04/15/2025SE |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional | 02/10/2025SE |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional | 02/10/2025SE |
| K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in…JWY · Traditional | 12/19/2024SE |
Questions and answers
When was The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL cleared by the FDA?
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (K243738) received a 510(k) decision of Substantially Equivalent on February 27, 2025, 85 days after the submission was received.
What is the product code of K243738?
The FDA product code is NGZ – Susceptibility Test Plate, Antifungal, a Class II (moderate risk) device regulated under 21 CFR 866.1640.