(60 days)
The MTS (MC Test Strip) Lefamulin 0.016 - 256 µg/mL is a quanttative method intended for the in vitro determination of animicrobal susceptbility of bacteria. 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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Lefamilin at concentrations of 0.016 - 256 ug/mL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.
Lefamulin has been shown to be active both clinically and in viro against these bacterial species according to the FDA drug approved label:
Gram-positive bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates)
Gram-Negative bacteria Haemophilus influenzae
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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria.
The document is a 510(k) clearance letter from the FDA for a device named "MTS Lefamulin 0.016- 256 μg/mL." It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use of the device, which is a quantitative method for the in vitro determination of antimicrobial susceptibility of bacteria using Lefamulin.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample size, ground truth details, MRMC study, etc.) from the given text.
§ 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).