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The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of von Willebrand Factor Activity (vWF:Act) in citrated human plasma.

The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate formal, similar to the predicate device. Diluted patient plasma is incubated in the wells, allowing any available antigen to bind to the monoclonal antibody on the microwell surface. The plates are washed to remove unbound proteins or other plasma molecules. Bound antigen is quantitated using horseradish peroxidase (HRP) conjugated anti-human von Willebrand Factor antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450mm. Patient von Willebrand Factor Activity in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. The total incubation time (at room temperature) of the assay is 40 minutes.

The provided text describes a 510(k) submission for the REAADS von Willebrand Factor Activity Test Kit. This is an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, many of the requested categories (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not directly applicable or reported in the context of an IVD submission.

However, I can extract the information that is available and relevant to an IVD device's acceptance criteria and study.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For IVDs, "acceptance criteria" are typically related to the analytical performance (e.g., correlation, precision, linearity) compared to a predicate device. The primary "performance" reported here is the correlation with the predicate device.

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