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The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Fluconazole with new FDA breakpoints and indications for testing Candida spp. on the Sensititre YeastOne Susceptibility System. Fluconazole has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida parapsilosis

The Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

This document is a 510(k) clearance letter for the Sensititre YeastOne Susceptibility System with Fluconazole. It does not contain the detailed study information (acceptance criteria, device performance, sample sizes, expert qualifications, etc.) that you are requesting.

The letter primarily:

• Confirms that the device is substantially equivalent to a legally marketed predicate device.
• States the regulation number, regulation name, and product code.
• Outlines the general controls provisions of the Act that the manufacturer must comply with.
• Specifies the Indications for Use for the device, listing the Candida species against which Fluconazole has shown activity.

To obtain the information regarding acceptance criteria and the study proving the device meets those criteria, one would typically need to refer to the 510(k) summary or the full 510(k) submission for K221198, which are usually more detailed technical documents. These documents are often publicly available via the FDA's 510(k) database if they are submitted as non-confidential information.

Therefore, I cannot fulfill your request with the provided text. The document does not contain the requested information about device performance metrics, study design, or ground truth establishment.

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