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

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This document is an FDA 510(k) clearance letter for the VISTA™ Antigen Brucella abortus device. It does not contain details about acceptance criteria, study design, or performance metrics beyond the statement that the device is "substantially equivalent" to predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert qualifications, or ground truth methods from this document. The letter primarily confirms regulatory clearance based on substantial equivalence to existing devices, without detailing the specific performance studies that led to this determination.

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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 text is a 510(k) premarket notification letter from the FDA to Lee Laboratories regarding the VISTA™ Antigen Brucella melitensis device. This document primarily focuses on regulatory approval and does not contain the detailed study information needed to answer the specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. However, it does not provide the specific performance data or the study design details that would be found in a clinical or validation study report.

Therefore, most of the information requested cannot be extracted from this document.

Here's what can be stated based on the provided text:

• Device Name: VISTA™ Antigen Brucella melitensis
• Indications For Use: Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum.

All other points (acceptance criteria, reported device performance, sample sizes, data provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not present in this regulatory approval letter.

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