(63 days)
The Sensitite HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
The Sensititire 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 the addition of Telavancin in the dilution range of 0.001-2μg/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 -24 hour MIC panel in the dilution range of 0.03-16μg/ml for testing Gram positive isolates, The approved primary "Indications for Use" and clinical significance of Telavancin is for:
Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Enterococcus faecalis Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermidius, and S. constellatus)
In vitro data, without clinical correlation is provided for: Facultative Gram-Positive Microorganisms: Enterococcus faecium (vancomycin-susceptible Isolates only) Staphylococcus haemolyticus Streptococcus dysgalactiae subsp, equisimilis Staphylococcus epidermidis
Not Found
The provided text is a cover letter from the FDA to Trek Diagnostic Systems Inc. regarding the clearance of their Sensititre HP susceptibility plate and Sensititre 18-24 hour susceptibility plate. It confirms that the devices are substantially equivalent to legally marketed predicate devices. The letter also includes the Indications for Use for the devices, specifically for the addition of Telavancin.
Unfortunately, the provided document does not contain the specific acceptance criteria, study details, or performance data that directly answer your questions. This document is a regulatory approval letter, not a scientific study report.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established from this document.
To obtain the information you're looking for, you would typically need to consult a different type of document, such as:
- The 510(k) premarket notification summary submitted by Trek Diagnostic Systems Inc. to the FDA (which often includes a summary of the studies and performance data).
- A scientific publication describing the validation studies for these devices.
- The actual study report submitted to the FDA during the clearance process.
§ 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).