NGZ — Susceptibility Test Plate, Antifungal Class II
FDA product code NGZ covers "Susceptibility Test Plate, Antifungal", a Class II medical device regulated under 21 CFR 866.1640. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NGZ
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243738 | thermo fisher scientific | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution ra | February 27, 2025 |
| K232967 | biomerieux | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | June 12, 2024 |
| K232963 | biomerieux | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | June 7, 2024 |
| K231433 | thermo fisher scientific | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution ra | August 31, 2023 |
| K221198 | thermo fisher scientific | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range | March 10, 2023 |
| K221899 | thermo fisher scientific | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution r | January 20, 2023 |
| K211539 | thermo fisher scientific | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution rang | December 15, 2021 |
| K181368 | biomerieux | VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) | June 20, 2018 |
| K151923 | biomerieux | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) | March 25, 2016 |
| K151817 | biomerieux | VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL | February 18, 2016 |
| K133952 | biomerieux | VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE | August 19, 2014 |
| K133817 | biomerieux | VITEK 2 AST - YEAST FLUCONAZOLE | August 5, 2014 |
| K133038 | trek diagnostic systems | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | January 31, 2014 |
| K101566 | biomerieux | VITEK 2 YEAST CASPOFUNGIN | September 28, 2010 |
| K092454 | biomerieux | VITEK 2 YEAST VORICONAZOLE | May 21, 2010 |
| K082534 | ab biomerieux | ETEST VORICONAZOLE 0.002-32 UG/ML | November 2, 2009 |
| K090968 | trek diagnostic systems | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | June 4, 2009 |
| K081063 | trek diagnostic systems | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | March 6, 2009 |
| K061945 | biomerieux | VITEK 2 AST-YS FLUCONAZOLE | September 19, 2006 |
| K040560 | ab biodisk | ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING | July 27, 2004 |