Susceptibility Test Plate, Antifungal

FDA product code NGZ · Class II (moderate risk) · 21 CFR 866.1640 · 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.

21510(k) clearances
0PMA approvals
4recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of…NGZ · Traditional Thermo Fisher Scientific02/27/2025SE
K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)NGZ · Traditional bioMerieux, Inc.06/12/2024SE
K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)NGZ · Traditional bioMerieux, Inc.06/07/2024SE
K231433The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of…NGZ · Traditional Thermo Fisher Scientific08/31/2023SE
K221198Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of…NGZ · Traditional Thermo Fisher Scientific03/10/2023SE
K221899The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of…NGZ · Traditional Thermo Fisher Scientific01/20/2023SE
K211539Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of…NGZ · Traditional Thermo Fisher Scientific12/15/2021SE
K181368VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)NGZ · Special bioMerieux, Inc.06/20/2018SE
K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)NGZ · Traditional bioMerieux, Inc.03/25/2016SE
K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLNGZ · Traditional bioMerieux, Inc.02/18/2016SE
K133952Vitek 2 Ast Ys Flucytosine, Vitek 2 Ast Yeast FlucytosineNGZ · Traditional bioMerieux, Inc.08/19/2014SE
K133817Vitek 2 Ast - Yeast FluconazoleNGZ · Traditional bioMerieux, Inc.08/05/2014SE
K133038Sensititre Yeastone Susceptibility PlatesNGZ · Traditional Trek Diagnostic Systems01/31/2014SE
K101566Vitek 2 Yeast CaspofunginNGZ · Traditional bioMerieux, Inc.09/28/2010SE
K092454Vitek 2 Yeast VoriconazoleNGZ · Traditional bioMerieux, Inc.05/21/2010SE
K082534Etest Voriconazole 0.002-32 Ug/MlNGZ · Traditional Ab Biomerieux11/02/2009SE
K090968Sensititre Yeastone Susceptibility PlatesNGZ · Traditional Trek Diagnostic Systems, Inc.06/04/2009SE
K081063Sensititre Yeastone Susceptibility Plates- Additional AntimicrobicsNGZ · Traditional Trek Diagnostic Systems, Inc.03/06/2009SE
K061945Vitek 2 Ast-Ys FluconazoleNGZ · Traditional bioMerieux, Inc.09/19/2006SE
K040560Etest for Antifungal Suscepttibility TestingNGZ · Traditional Ab Biodisk07/27/2004SE
K991810Modification to Sensititre Yeastone Mic Susceptibility TestNGZ · Traditional Trek Diagnostic Systems, Inc.10/09/2001SE

Recalls

RecallProductFirmInitiated
Z-1806-2026 Class IIYeastone Broth, 11ML, 10/BOX YY3462Products may report incorrect AST results during quality control. Health consequences may include delayed… Remel, Inc03/24/2026Open, Classified
Z-0824-2023 Class IIETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333As the temperature and time out of range was exceeded, product performances cannot be guaranteed Biomerieux Inc11/09/2022Open, Classified
Z-0792-2023 Class IIVITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226As the temperature and time out of range was exceeded, product performances cannot be guaranteed Biomerieux Inc11/09/2022Open, Classified
Z-2378-2017 Class IIVITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… Biomerieux Inc04/20/2017Terminated