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The Sensitite YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candido spp. This 510(k) is for Rezafungin in the dilution range of 0.008 - 8 ug/mL for testing Candida spp. on the Sensititer YeastOne Susceptibility System. Rezafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drup label: Candida albicans Candida glabrata Candida parapsilosis.

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The provided text is a 510(k) clearance letter for the Sensititre YeastOne Susceptibility System with Rezafungin. It does not contain the detailed study information required to answer your specific questions about acceptance criteria and study design. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include the performance data, sample sizes, ground truth establishment, or expert details that would typically be found in a study report or a more comprehensive FDA review document.

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