(317 days)
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 µg/mL)
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets acceptance criteria.
The document is an FDA 510(k) clearance letter for a device called "Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest." It confirms that the device has been found substantially equivalent to predicate devices.
While the letter mentions the regulation number, product code, and regulatory class, it does not contain any details about the performance criteria, study design, sample sizes, expert qualifications, ground truth establishment, or any of the other specific information requested in your prompt regarding device acceptance and performance studies.
Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance 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).