(56 days)
The Sensitite 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 dalbavancin in the dilution range of 0.0005 - 2ug/ml with new FDA breakpoints for testing fastidious Streptococus spp. on the Sensitite 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System.
Dalbavancin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus agalactiae Streptococcus pyogenes Streptococcus anginosus group (S. anginosus, S. constellatus and S. intermedius)
Not Found
The provided text describes a 510(k) premarket notification for a medical device and includes the Indications for Use, but it does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.
The document is a clearance letter from the FDA, confirming that the device (Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin) is substantially equivalent to a legally marketed predicate device. While this letter refers to the device and its intended use, it does not provide the technical details of the validation studies.
Therefore, I cannot provide the requested information from the given text. To answer your questions, one would need to review the actual 510(k) summary document or the underlying clinical/performance study reports that were submitted to the FDA for review.
§ 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).