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

• K Number: K211539
• Device Name: Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
• Manufacturer: Thermo Fisher Scientific
• Date Cleared: 2021-12-15 ( 211 days)
• Product Code: NGZ
• Regulation Number: 866.1640
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a medical device (Sensititre YeastOne Susceptibility System with Voriconazole), but it does not include the specifics of the performance study.

The requested information such as a table of acceptance criteria, reported performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone performance, type of ground truth, and training set details are not present in this document.

While it mentions the device and its intended use, it does not delve into the scientific study details.

Regulation Number and Section

§ 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).