510(k) K133038

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES by Trek Diagnostic Systems — Product Code NGZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 31, 2014
Date Received: September 26, 2013
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Susceptibility Test Plate, Antifungal
Device Class: Class II
Regulation Number: 866.1640
Review Panel: MI
Submission Type

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.

Other clearances by Trek Diagnostic Systems

K112276 — VIZION (November 16, 2011)
K111615 — SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES (November 8, 2011)
K110583 — SENSITITRE OPTIREAD (September 22, 2011)
K103532 — AUTOREADER 2 (August 26, 2011)
K111429 — SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND TH (August 18, 2011)
K103456 — THE SENSITITRE AIM (June 22, 2011)
K110331 — SENSITITRE AIM (TM) (April 27, 2011)
K093741 — SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILI (February 25, 2010)
K093865 — SENSITITRE 18-24HR SUSCEPTIBILITY PLATES (February 17, 2010)
K092445 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (December 16, 2009)

Other clearances for product code NGZ

K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution ra (February 27, 2025)
K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (June 12, 2024)
K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (June 7, 2024)
K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution ra (August 31, 2023)
K221198 — Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range (March 10, 2023)
K221899 — The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution r (January 20, 2023)
K211539 — Sensititre YeastOne Susceptibility System with Voriconazole in the dilution rang (December 15, 2021)
K181368 — VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) (June 20, 2018)
K151923 — VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (March 25, 2016)
K151817 — VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL (February 18, 2016)