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The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial suscretibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example. Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, Haemophilus and Streptococcus species and N. gonorrhoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The purpose of this 510(k) is specifically for the vancomycin MTS at concentrations of 0.016 - 256 us/mL interpreted after 24 hours incubation.

The non-fastidious bacteria that have been shown to be active both clinically and in vitro against vancomycin according to the FDA label are:

Staphylococcus aureus and Staphylococcus epidermis (including methicillin resistant strains) Enterococcus faecalis Enterococcus faecium

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The provided text describes the 510(k) premarket notification for the Liofilchem MIC Test Strip (MTS) - Vancomycin 0.016 - 256 ug/mL. While it outlines the device's indications for use and regulatory information, it does not contain the detailed study results, acceptance criteria, or performance data typically required to answer your specific questions about device performance and study methodology.

The letter explicitly states that it is a "substantially equivalent letter" and notes that "FDR does not evaluate information related to contract liability warranties." This indicates that the detailed performance data that would normally be found in a study report proving device meets acceptance criteria is not part of this specific document.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the actual scientific study report or clinical trial documentation that was submitted to the FDA for the K153687 premarket notification, which would include sections on acceptance criteria, study design, results, and statistical analysis.

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