Cleared Traditional

Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL

K211539 · Thermo Fisher Scientific · Microbiology
Dec 2021
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K211539 is an FDA 510(k) clearance for the Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL, a Susceptibility Test Plate, Antifungal (Class II — Special Controls, product code NGZ), submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on December 15, 2021, 211 days after receiving the submission on May 18, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K211539 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2021
Decision Date December 15, 2021
Days to Decision 211 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.

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