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Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Meropenem these include Enterobacteriaceae, and Staphylococcus spp. Pseudomonas spp. and by modified procedures Haemophilus influenzae and Streptococcus pneumoniae.

Oxoid Meropenem Susceptibility Test Disc

This is an FDA Premarket Notification (510(k)) summary for an in vitro diagnostic device, not a study report for an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies is not available in the provided text.

The document states that the "Oxoid Meropenem Susceptibility Test Disc" is for semi-quantitative susceptibility testing of rapidly growing micro-organisms, including Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Haemophilus influenzae, and Streptococcus pneumoniae. It is regulated as a Class II device with product code JTN.

The FDA has determined that this device is substantially equivalent to legally marketed predicate devices, meaning it performs as safely and effectively as a previously cleared device. This determination is not based on a new clinical study with acceptance criteria as would be required for novel AI/ML devices, but rather on demonstrating equivalence to existing technology.

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