K-number	K243738
Device name	The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
Applicant	Thermo Fisher Scientific
Product code	NGZ
Device class	Class II
Decision date	Feb 27, 2025
Decision	Substantially Equivalent
Regulation	866.1640

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Sensititre YeastOne Susceptibility System with Micafungin is an in vitro diagnostic device for clinical susceptibility testing of Candida species. It tests micafungin at dilution concentrations ranging from 0.008-16 µg/mL to determine the susceptibility of six Candida species (albicans, glabrata, guilliermondi, krusei, parapsilosis, and tropicalis) to this antifungal drug.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary. The document states the device is substantially equivalent to legally marketed predicate devices and that FDA's substantial equivalence determination included clearance of a Predetermined Change Control Plan, but does not articulate the specific comparative reasoning, performance data, or design similarities that support the substantial equivalence conclusion.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL

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