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The contents of the Peliclass ™ subclass nephelometric Array® kit will allow quantitative determination of all four IgG subclasses in at least 25 samples with the Beckman Array ® Protein System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.

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This document is a 510(k) clearance letter from the FDA for a medical device (Peliclass Human IGG Subclass Nephelometric Array Kit). It does not contain specific information about acceptance criteria or a study that proves the device meets those criteria in the way described in your request.

The letter confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This substantial equivalence is based on the information provided by the manufacturer in their 510(k) submission, which typically includes performance data. However, the letter itself does not detail that data.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on a detailed scientific study report.

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