(135 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 510(k) is for the newly approved Oritavancin in the dilution range of 0.0005-8 ug/ml for testing non-fastidious gram positive organisms on the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin susceptible (MSSA) isolates) Enterococcus faecalis(vancomycin-susceptible isolates only)
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Oritavancin. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the given input. The document primarily focuses on regulatory clearance and indications for use.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).