Cleared Traditional

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES

K133038 · Trek Diagnostic Systems · Microbiology

Jan 2014

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K133038 is an FDA 510(k) clearance for the SENSITITRE YEASTONE SUSCEPTIBILITY PLATES, a Susceptibility Test Plate, Antifungal (Class II — Special Controls, product code NGZ), submitted by Trek Diagnostic Systems (Oakwood Village, US). The FDA issued a Cleared decision on January 31, 2014, 127 days after receiving the submission on September 26, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K133038 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2013
Decision Date	January 31, 2014
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	NGZ — Susceptibility Test Plate, Antifungal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640
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.