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The IMMULITE® 2000 Allergen-Specific IgE and mixed allergen panels are for in vitro diagnostic use with the IMMULITE® 2000 Analyzer – for the measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

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I am sorry, but the provided text from the FDA 510(k) letter for the IMMULITE® 2000 Mixed Allergen Panels does not contain the detailed study information required to answer your request.

The letter is primarily a notification of substantial equivalence for a medical device and does not include:

• Acceptance criteria and reported device performance: While it states the device is for "measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders," it does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy) or the acceptance criteria for those metrics.
• Sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth details: These types of details about a clinical study are not typically found in this type of FDA clearance letter. Such information would be present in the 510(k) submission itself or in a summary document if one were publicly available.

Therefore, I cannot populate the table or provide the specific study details you requested based on the given input.

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