(49 days)
The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Streptococcus spps to Tetracycline (0.5 -8 ug/mL), Trimethoprim/Sulphamethoxazole (0.5/9.5-4/76 ug/mL), Vancomycin (0.5-4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.
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The provided text is a 510(k) premarket notification letter from the FDA, approving the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. It mentions that the device is substantially equivalent to a predicate and that the company provided a submission document, but the letter itself does not contain the detailed study results, acceptance criteria, or performance data.
Therefore, I cannot extract the specific information requested in your prompt based solely on the provided FDA letter. The letter refers to a "premarket notification of intent to market the device" which would contain such information, but that document is not provided here.
To answer your request, I would need access to the actual 510(k) submission document or a summary thereof, which would detail the study performed to demonstrate substantial equivalence, including acceptance criteria and performance data.
§ 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).