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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

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The provided document is a 510(k) clearance letter from the FDA for the VISTA™ Antigen Salmonella H a device. It primarily focuses on the regulatory approval and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a performance evaluation section of a 510(k) submission.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because this document does not contain that level of detail.

The letter states that the device is "substantially equivalent" to previously marketed devices for "screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum." This implies that Lee Laboratories submitted data demonstrating this equivalence, but the specifics of that data are not included in this FDA clearance letter.

To answer your questions, I would need access to the actual 510(k) submission document, particularly the sections detailing performance studies, intended use, and acceptance criteria.

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