Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
FDA 510(k) K221198 · Thermo Fisher Scientific
510(k) numberK221198
Submission
- Device name
- Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
- Applicant
- Thermo Fisher Scientific
Oakwood Village, OH, US - Received
- April 26, 2022
- Decision date
- March 10, 2023
- 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.
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| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of…NGZ · Traditional | Thermo Fisher Scientific | 02/27/2025SE |
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| 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 |
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| 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.
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| 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 |
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of…NGZ · Traditional | 02/27/2025SE |
| 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 |
Questions and answers
When was Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL cleared by the FDA?
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198) received a 510(k) decision of Substantially Equivalent on March 10, 2023, 318 days after the submission was received.
What is the product code of K221198?
The FDA product code is NGZ – Susceptibility Test Plate, Antifungal, a Class II (moderate risk) device regulated under 21 CFR 866.1640.