(87 days)
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.
This 510(k) is for the addition of Sparfloxacin in the dilution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. Organisms indicated for testing in the approved FDA Sparfloxacin package insert include Enterobacter cloacae and Klebsiella pneumoniae.
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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets particular criteria. The letter primarily addresses the substantial equivalence determination for the "Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin" and its regulatory classification.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this 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).