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Thermo Scientific Oxoid Antimicrobial Susceptibility Test (AST) Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing.

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 can be used to determine susceptibility to Eravacycline against the following bacteria for which Eravacycline has been shown to be active both clinically and in vitro: Gram-negative bacteria: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

In vitro data are available for the following microorganisms, but clinical significance is unknown: Gram-negative bacteria: Citrobacter koseri Klebsiella aerogenes

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The provided text is a 510(k) clearance letter from the FDA for the Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, it does not include acceptance criteria for the device or a study proving that the device meets such criteria.

The document primarily states the regulatory clearance, the device's intended use (Antimicrobial Susceptibility Test Disc for in vitro susceptibility testing against specific Gram-negative bacteria), and regulatory information. It lacks the technical details of a study, including sample sizes, ground truth establishment, expert qualifications, or performance metrics.

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

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