(106 days)
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.
Therefore, I cannot provide the requested information based on the input text.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).