(177 days)
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates. This 510(k) is for Ceftolozane/Tazobactam in the dilution range of 0.03/4 - 64/4 ug/mL for testing non-fastidious gram negative organisms on the Sensititre 18-24 hour MIC panel. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram negative isolates: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
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I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an "Indications for Use" statement for "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftolozane/Tazobactam." It does not contain the detailed study information, acceptance criteria, or performance data that you requested.
Therefore, I cannot provide the specific details regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or ground truth establishment for test and training sets.
- Information about experts, adjudication methods, or MRMC comparative effectiveness studies.
- Whether a standalone performance study was done.
The document focuses on the regulatory clearance and the specific organisms the device is indicated to test against, not the underlying validation study details.
§ 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).