(123 days)
The Sensititre HP MIC susceptibility Plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for the newly approved Breakpoints for Telavancin, utilizing the 0.002% Polysorbate 80 for the reference method in the dilution range of 0.0005-2ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. The approved primary "Indications for Use" and clinical significance for Streptococcus spp. is for the following species: Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus.
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.
The document is a 510(k) clearance letter from the FDA for a medical device called "Sensititre HP MIC Susceptibility Plate with Telavancin". While it states the device has been reviewed and determined substantially equivalent to a predicate device, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test or training sets, or data provenance.
- Information on a study to prove the device meets acceptance criteria, including the number and qualifications of experts, adjudication methods, or MRMC studies.
- Specification of ground truth type or how it was established.
The provided text is primarily a regulatory approval document and not a scientific study report.
§ 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).