NGZ · Susceptibility Test Plate, Antifungal
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | NGZ |
|---|---|
| Device Name | Susceptibility Test Plate, Antifungal |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | Thermo Fisher Scientific | Feb 27, 2025 | SESE |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | bioMerieux, Inc. | Jun 12, 2024 | SESE |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | bioMerieux, Inc. | Jun 7, 2024 | SESE |
| K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL | Thermo Fisher Scientific | Aug 31, 2023 | SESE |
| K221198 | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL | Thermo Fisher Scientific | Mar 10, 2023 | SESE |
| K221899 | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml | Thermo Fisher Scientific | Jan 20, 2023 | SESE |
| K211539 | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL | Thermo Fisher Scientific | Dec 15, 2021 | SESE |
| K181368 | VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) | bioMerieux, Inc. | Jun 20, 2018 | SESE |
| K151923 | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) | bioMerieux, Inc. | Mar 25, 2016 | SESE |
| K151817 | VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL | bioMerieux, Inc. | Feb 18, 2016 | SESE |
| K133952 | VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE | bioMerieux, Inc. | Aug 19, 2014 | SESE |
| K133817 | VITEK 2 AST - YEAST FLUCONAZOLE | bioMerieux, Inc. | Aug 5, 2014 | SESE |
| K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Trek Diagnostic Systems | Jan 31, 2014 | SESE |
| K101566 | VITEK 2 YEAST CASPOFUNGIN | bioMerieux, Inc. | Sep 28, 2010 | SESE |
| K092454 | VITEK 2 YEAST VORICONAZOLE | bioMerieux, Inc. | May 21, 2010 | SESE |
| K082534 | ETEST VORICONAZOLE 0.002-32 UG/ML | Ab Biomerieux | Nov 2, 2009 | SESE |
| K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | Jun 4, 2009 | SESE |
| K081063 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | Trek Diagnostic Systems, Inc. | Mar 6, 2009 | SESE |
| K061945 | VITEK 2 AST-YS FLUCONAZOLE | bioMerieux, Inc. | Sep 19, 2006 | SESE |
| K040560 | ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING | Ab Biodisk | Jul 27, 2004 | SESE |
Top Applicants
- bioMerieux, Inc. — 10 clearances
- Thermo Fisher Scientific — 5 clearances
- Trek Diagnostic Systems, Inc. — 3 clearances
- Ab Biodisk — 1 clearance
- Ab Biomerieux — 1 clearance
