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

K211539 · Thermo Fisher Scientific · NGZ · Dec 15, 2021 · Microbiology

Device Facts

• Record ID: K211539
• Device Name: Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
• Applicant: Thermo Fisher Scientific
• Product Code: NGZ · Microbiology
• Decision Date: Dec 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 µg/mL is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Voriconazole with new FDA breakpoints and indications for testing Candida spp. on the Sensititre Yeastone Susceptibility System. Voriconazole has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans, Candida krusei, Candida parapsilosis

Device Story

The Sensititre YeastOne Susceptibility System is an in vitro diagnostic device used to determine the susceptibility of yeast to antifungal agents. It utilizes a microbroth dilution method where yeast samples are inoculated into test plates containing specific concentrations of the antifungal agent Voriconazole. The system measures the growth of the yeast in the presence of the drug to determine the Minimum Inhibitory Concentration (MIC). The device is intended for use in clinical laboratory settings by trained laboratory personnel. The output, in the form of an MIC value, assists healthcare providers in selecting appropriate antifungal therapy for patients with yeast infections, potentially improving clinical outcomes by guiding targeted treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including performance evaluations comparing the Sensititre YeastOne system's MIC results for Voriconazole against reference broth microdilution methods. Testing demonstrated acceptable essential agreement and categorical agreement between the subject device and the reference method.

Technological Characteristics

Microbroth dilution susceptibility test system. Consists of multi-well plates containing dehydrated antifungal agent (Voriconazole) in a dilution range of 0.008-8 ug/mL. Operates via colorimetric growth detection. Designed for in vitro diagnostic use in clinical laboratories. Standardized for yeast susceptibility testing.

Indications for Use

Indicated for use in the determination of susceptibility of yeast to the antifungal agent Voriconazole in the dilution range of 0.008-8 ug/mL.

Regulatory Classification

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.

Predicate Devices

• Sensititre Yeastone Susceptibility Plates (K133038)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Thermo Fisher Scientific Cynthia Knapp Director of AST/Pharma R&D 1 Thermo Fisher Way Oakwood Village, Ohio 44146

## Re: K211539

Trade/Device Name: Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008-8 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: NGZ Dated: May 10, 2021 Received: May 18, 2021

## Dear Cynthia Knapp:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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