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This kit is intended for the quantitative in vitro determination of human IgM in human serum, heparinised or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Human IgM Kit for use on the SPAPLUS™". This document confirms that the device has been found substantially equivalent to a legally marketed predicate device.

However, this document does not contain the detailed study information, acceptance criteria, or performance data that you have requested in your prompt. A 510(k) clearance letter typically does not include the specifics of the underlying studies that prove the device meets acceptance criteria. That information would usually be found in the 510(k) submission itself or in accompanying technical documentation, which is not provided here.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text.

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