K-number	K242658
Device name	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Apr 15, 2025
Decision	Substantially Equivalent
Regulation	866.1640

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin is an in vitro diagnostic device for clinical susceptibility testing of non-fastidious bacterial isolates. It tests susceptibility of Staphylococcus species and Enterococcus faecalis to moxifloxacin at concentrations ranging from 0.008 to 16 µg/mL, with results available in 18-24 hours.

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 confirms FDA determined substantial equivalence to legally marketed predicate devices and that the device demonstrated acceptable performance with the specified organisms, but does not articulate the specific technical or functional reasoning underlying the equivalence determination.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL

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