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The N-Assay TIA Plasminogen Test Kit is intended to be used for the squantitation of plasminogen in in human plasma by immuno-turbidimetric assay. Decreased levels of plasminogen are of clinical importance. Low levels of plasminogen are usually due to liver disease with impaired synthesis, or to increased utilization associated with DIC(disseminated intravascular coaculation). Low levels could also occur in severe nephrosis. Measurement of plasminogen is helpful in the diagnosis of these conditions.

N-Assay TIA Plasminogen Test Kit

I am sorry, but the provided text does not contain specific information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods for the "N-Assay TIA Plasminogen Test Kit."

The document is a 510(k) clearance letter from the FDA, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses the regulatory classification, general controls, and compliance requirements. It also states the intended use of the device for the quantitation of plasminogen in human plasma by immunoturbidimetric assay and highlights the clinical importance of plasminogen levels.

However, it does not include the detailed technical performance data or study results that would be necessary to populate a table of acceptance criteria and reported performance, or to answer the specific questions about the study design and ground truth establishment.

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