Search Results

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

Not Found

This document is an FDA 510(k) clearance letter for the VISTA™ Antigen Salmonella O Group B device, dated August 25, 1997. It declares substantial equivalence to a predicate device for the indication of "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."

The provided text does not contain the detailed study information required to answer your request regarding acceptance criteria and performance studies. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test sets, data provenance (country, retrospective/prospective).
• Details on the number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information about MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size and ground truth establishment for the training set.

The FDA letter confirms the device's clearance based on substantial equivalence, but it does not present the underlying study data that would detail how that substantial equivalence was demonstrated or specific performance metrics. To get that information, one would typically need to review the original 510(k) submission summary or detailed study reports, which are not included in this document.

Ask a specific question about this device