SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS

FDA 510(k) clearance K081063 · decided 2009-03-06

Clearance details

K-number: K081063
Device name: SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
Applicant: Trek Diagnostic Systems, Inc.
Decision: Substantially Equivalent
Date received: 2008-04-14
Decision date: 2009-03-06
Days to decision: 326 days
Clearance type: Traditional
Product code: NGZ
Device class: 2
Regulation number: 866.1640
Medical specialty: Microbiology
Advisory committee: Microbiology
Location: Cleveland, OH, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (K243738)	Thermo Fisher Scientific	2025-02-27
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 Scientific	2023-08-31
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198)	Thermo Fisher Scientific	2023-03-10
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899)	Thermo Fisher Scientific	2023-01-20
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL (K211539)	Thermo Fisher Scientific	2021-12-15
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

No recalls on record reference this clearance.