FDA Product Code NGZ: Susceptibility Test Plate, Antifungal
Fungal infections pose a significant and growing challenge in immunocompromised patients. FDA product code NGZ covers antifungal susceptibility test plates.
These devices contain panels of antifungal agents in microbroth dilution format to determine the minimum inhibitory concentration of antifungals against fungal isolates from clinical specimens. Results guide selection of antifungal therapy in invasive candidiasis, aspergillosis, and other serious fungal infections.
NGZ devices are Class II medical devices, regulated under 21 CFR 866.1640 and reviewed by the FDA Microbiology panel.
Leading manufacturers include bioMerieux, Inc. and Thermo Fisher Scientific.
21
Total
21
Cleared
231d
Avg days
2001
Since
Declining activity -
1 submissions in the last 2 years
vs 5 in the prior period
Review times improving: avg
85d
recently vs 238d historically
FDA 510(k) Cleared Susceptibility Test Plate, Antifungal Devices (Product Code NGZ)
21 devices
Cleared
Feb 27, 2025
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
Thermo Fisher Scientific
Microbiology
85d
Cleared
Jun 12, 2024
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
bioMerieux, Inc.
Microbiology
265d
Cleared
Jun 07, 2024
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
bioMerieux, Inc.
Microbiology
260d
Cleared
Aug 31, 2023
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
Thermo Fisher Scientific
Microbiology
106d
Cleared
Mar 10, 2023
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
Thermo Fisher Scientific
Microbiology
318d
Cleared
Jan 20, 2023
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
Thermo Fisher Scientific
Microbiology
204d
Cleared
Dec 15, 2021
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
Thermo Fisher Scientific
Microbiology
211d
Cleared
Jun 20, 2018
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
bioMerieux, Inc.
Microbiology
28d
Cleared
Mar 25, 2016
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
bioMerieux, Inc.
Microbiology
256d
Cleared
Feb 18, 2016
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
bioMerieux, Inc.
Microbiology
227d
Cleared
Aug 19, 2014
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
bioMerieux, Inc.
Microbiology
239d
Cleared
Aug 05, 2014
VITEK 2 AST - YEAST FLUCONAZOLE
bioMerieux, Inc.
Microbiology
232d
Cleared
Sep 28, 2010
VITEK 2 YEAST CASPOFUNGIN
bioMerieux, Inc.
Microbiology
116d
Cleared
May 21, 2010
VITEK 2 YEAST VORICONAZOLE
bioMerieux, Inc.
Microbiology
284d
Cleared
Sep 19, 2006
VITEK 2 AST-YS FLUCONAZOLE
bioMerieux, Inc.
Microbiology
71d
About Product Code NGZ - Regulatory Context
510(k) Submission Activity
21 total 510(k) submissions under product code NGZ since 2001, with 21 receiving FDA clearance (average review time: 231 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 5 in the prior period.
FDA 510(k) Review Time - NGZ Product Code
Recent submissions under NGZ have taken an average of 85 days to reach a decision - down from 238 days historically, suggesting improved FDA processing for this classification.
NGZ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →