Atlas FDA

NGZ

21 FDA 510(k) clearances · Product code

227 daysmedian time to decision
326 days90th percentile
21clearances measured

FDA profile

Official device name
Susceptibility Test Plate, Antifungal
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Medical specialty
Microbiology
FDA 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.
Adverse events (MAUDE)
2016: 9 · 2017: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (K243738)Thermo Fisher Scientific2025-02-27
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (K232967)bioMerieux, Inc.2024-06-12
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (K232963)bioMerieux, Inc.2024-06-07
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL (K231433)Thermo Fisher Scientific2023-08-31
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198)Thermo Fisher Scientific2023-03-10
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899)Thermo Fisher Scientific2023-01-20
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL (K211539)Thermo Fisher Scientific2021-12-15
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) (K181368)bioMerieux, Inc.2018-06-20
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (K151923)bioMerieux, Inc.2016-03-25
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL (K151817)bioMerieux, Inc.2016-02-18
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE (K133952)bioMerieux, Inc.2014-08-19
VITEK 2 AST - YEAST FLUCONAZOLE (K133817)bioMerieux, Inc.2014-08-05
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (K133038)Trek Diagnostic Systems2014-01-31
VITEK 2 YEAST CASPOFUNGIN (K101566)bioMerieux, Inc.2010-09-28
VITEK 2 YEAST VORICONAZOLE (K092454)bioMerieux, Inc.2010-05-21
ETEST VORICONAZOLE 0.002-32 UG/ML (K082534)Ab Biomerieux2009-11-02
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (K090968)Trek Diagnostic Systems, Inc.2009-06-04
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS (K081063)Trek Diagnostic Systems, Inc.2009-03-06
VITEK 2 AST-YS FLUCONAZOLE (K061945)bioMerieux, Inc.2006-09-19
ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING (K040560)Ab Biodisk2004-07-27
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST (K991810)Trek Diagnostic Systems, Inc.2001-10-09

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Every clearance here is in the API, with alerts when new ones post.