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Serodia-TP-PA is a qualitative gelatin particle agglutination assay intended to be used for the detection of Treponema pallidum antibodies in human serum or plasma as an aid in the diagnosis of syphilis. This product is not cleared or approved by the U.S. Food and Drug Administration (FDA) for use in screening blood or plasma donors.

Particle Agglutination Test

The provided text is a 510(k) clearance letter for the Serodia TP-PA Syphilis Particle Agglutination Test. It states that the device is substantially equivalent to a legally marketed predicate device but does not contain any information about acceptance criteria or specific studies performed to prove device performance.

The letter is primarily focused on regulatory approval and classification, not on the detailed technical specifications or performance data of the device.

Therefore, I cannot provide the requested information based on the given input. The document does not describe:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size or establishment of ground truth for training sets.

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