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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the addition of Ertapenem in the dilution range of 0.002 -16 ug/ml for gram negative organisms and 0.015-64ug/ml for gram positive organisms to the Sensititre 18 - 24 hour MIC panel for testing gram positive and gram negative isolates. The approved primary "Indications for Use" and clinical significance of Ertapenem is for: Staphylococcus species (methicillin-susceptible strains), Streptococcus agalactiae, Steptococcus pyogenes, Escherichia coli, and Klebsiella pneumoniae. In vitro data, without clinical correlation is provided for: Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii, Proteus mirabilis, Proteus vulgaris, and Serratia marcescens.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a Susceptibility Test Panel for Ertapenem. It grants market clearance for the device but does not contain information on acceptance criteria or the study details that prove the device meets these criteria.

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• The specific acceptance criteria (e.g., accuracy percentages, agreement rates).
• The design and results of a clinical or performance study.
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