Search Results

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: "Dtest". The Dtest for Broth Microdilution Test is for Staphylococcus spp. resistant to (MIC's ≥ 8ug/ml) erythromycin and susceptible or intermediate (MIC's < 2ug/ml) to clindamycin. With these isolates a Dtest 1 (4/0.5 ug/ml) or 2 (8/1.5 ug/ml) or both 1 and 2 are positive (growth) the test should be reported as inducible clindamycin resistance. If with these isolates there is no growth in both Dtest 1 and 2 the isolates should be reported as negative for inducible resistance.

Not Found

This document is a 510(k) premarket notification decision letter for The Sensititre® 18-24 MIC or BP Susceptibility System with Dtest 1 and 2 for Staphylococcus spp. It states that the device is substantially equivalent to legally marketed predicate devices. The document does not contain acceptance criteria for device performance or a study proving it meets these criteria. It provides an "Indications for Use" statement, but no performance data. Therefore, the requested information cannot be extracted from the provided text.

Ask a specific question about this device