(92 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 linezolid in the dilution range of 0.25-32 ug/mL for testing non-fastive isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Linezolid has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Enterococcus faecium (vancomycin-resistant isolates only) Staphylococcus aureus (including methicillin-resistant isolates) Linezolid has been shown to be active in vitro only against the following organisms according to the FDA drug label: Enterococcus faecalis (including vancomycin-resistant isolates) Enterococcus faecium (vancomycin-susceptible isolates) Staphylococcus epidermidis (including methicillin-resistant isolates) Staphylococcus haemolyticus
Not Found
The provided text describes a 510(k) premarket notification for a medical device: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL. This device is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates to the antibiotic Linezolid.
However, the provided text does not contain any information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies related to the device's performance or testing against acceptance criteria.
The document is a clearance letter from the FDA, indicating that the device has been found substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance, labeling, quality system regulations, and adverse event reporting, but it does not detail the specific performance studies that led to this determination.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the provided document.
§ 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).