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The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The Erythromycin MTS at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation.

Erythromycin has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label:

Staphylococcus aureus

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

The provided text is a 510(k) summary for the Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256μg/mL, an antimicrobial susceptibility test. It details the FDA's substantial equivalence determination. However, the document does not contain the acceptance criteria, the study details proving the device meets those criteria, or any information about sample sizes, ground truth establishment, expert involvement, or MRMC studies.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval and indications for use, not the technical study results.

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