(118 days)
For in vitro diagnostic use:
System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.
This 510(k) application is for System U3/Ciprofloxacin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 1 ug/ml, Intermediate 2 ug/ml and Resistant ≥ 4 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.
System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.
The provided text is a 510(k) clearance letter from the FDA for a device called "System U3™ for Ciprofloxacin." It does not contain the detailed study information required to answer the questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications.
The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This means that instead of providing a new study that meets specific acceptance criteria, the manufacturer demonstrated that their device performs similarly to an already approved device. The letter focuses on regulatory approval rather than a detailed performance study.
Therefore, I cannot provide the requested information from the given text. A typical 510(k) clearance letter does not include the specifics of a clinical validation study. These details would be in the full 510(k) submission, which is not provided here.
§ 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).