K-number	K252014
Device name	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Aug 28, 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 Amikacin is an in vitro diagnostic device for clinical antimicrobial susceptibility testing of non-fastidious gram-negative bacteria. It measures amikacin susceptibility across a dilution range of 0.25-256 µg/mL and is indicated for testing Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

The document does not provide the specific reasoning for substantial equivalence. It states the device was determined to be substantially equivalent to legally marketed predicate devices but does not detail the comparison of design, performance, or functional characteristics that support this 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 Amikacin in the dilution range of 0.25-256 ug/mL

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