K-number	K242659
Device name	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	May 22, 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 Vancomycin is an in vitro diagnostic device for clinical antimicrobial susceptibility testing of non-fastidious gram-positive bacteria. It measures vancomycin susceptibility in the concentration range of 0.25-128 µg/mL for Staphylococcus aureus (including MRSA), other staphylococci species, and Enterococcus species.

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 substantial equivalence was determined but does not detail the comparative analysis, testing data, or specific predicate device comparisons that formed the basis for that 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 Vancomycin in the dilution range of 0.25-128 ug/mL

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