(89 days)
The Sensititre 20 - 24-hour Haemophilus influenzae Streptococcus pneumoniae MIC or Break is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Delafloxacin in the dilution range of 0.00025-8 ug/ml for testing fastidious Streptococcus spp., (including S. pneumoniae) and delafloxacin in the dilution range of 0.000125 - 8 ug/mL for testing H. influenzae on the Sensititre 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Delafloxacin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: For Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus grp. For Community Acquired Bacterial Pneumonia (CABP) Streptococcus pneumoniae Haemophilus influenzae
Not Found
The provide FDA 510(k) summary does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format.
The document is a clearance letter for a medical device (Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin), indicating it has been deemed substantially equivalent to a predicate device. While it mentions the device's intended use and the specific drug for susceptibility testing, it does not include the specifics of the performance study.
Typically, such information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details) would be explicitly laid out in the 510(k) summary submitted by the manufacturer to the FDA. The provided text is the FDA's response to that submission and does not detail the underlying studies.
Therefore, I cannot provide the answer in the requested format based on the given input.
§ 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).