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The MTS (MIC Test Strip) Omadacycline 0.002 - 32 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTSTM consists of specialized paper impregated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum infortory concentration (MC) in ugimL of antimicrobial agents agamst bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Omadacycline at concentrations of 0.002 - 32 ugimL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.

Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

Gram-Positive bacteria Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis Streptococcus pneumoniae Streptococcus pyogenes Streptococcus anginosus group (includes S. anginosus and S. constellatus) Gram-Negative bacteria Enterobacter cloacae Klebsiella pneumoniae Haemophilus influenzae Haemophilus parainfluenzae

Omalacycline has been shown to be active in vitro only against the bacterial species listed below according to the FDA drug approved label:

Gram-Positive bacteria Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Gram-Negative bacteria Escherichia coli Citrobacter freundii

Citrohacter koseri lebstella aerogenes

Not Found

The provided text is a 510(k) clearance letter from the FDA for an antimicrobial susceptibility test system (MTS Omadacycline 0.002 - 32 µg/mL). It does not contain the acceptance criteria or details of a study proving the device meets acceptance criteria as typically found in a clinical trial report or a more detailed submission summary.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device meets the regulatory requirements for clearance without requiring an approval of a premarket approval application (PMA). However, the specific performance data against acceptance criteria that led to this determination is not present in this letter.

Therefore, I cannot provide the requested information based only on the input text. The input document is a regulatory clearance letter, not a detailed study report.

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