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510(k) K133038

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

K133038 is an FDA 510(k) premarket notification submitted by Trek Diagnostic Systems for the device "SENSITITRE YEASTONE SUSCEPTIBILITY PLATES". The FDA issued a decision of Substantially Equivalent on January 31, 2014. The device falls under product code NGZ (Susceptibility Test Plate, Antifungal), a Class II device regulated under 21 CFR 866.1640. Trek Diagnostic Systems has at least 10 other 510(k) clearances on record.

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)

FDA data resources