(91 days)
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MC or Breakpoint System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for imipenem in the dilution range of 0.015 - 4 ug/ml for testing fastidious Streptococcus pneumoniae isolates on the Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Imipenem has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae
Not Found
I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for an antimicrobial susceptibility testing system, but it does not detail the specific performance acceptance criteria or the study results that demonstrate the device meets those criteria.
§ 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).