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The AP 3600 Automated Instrument, in conjunction with the OPTIGEN Allergen-Specific IgE Assay, is for the semiquantitative measurement of circulating allergen-specific IgE antibodies in human serum. The OPTIGEN Allergen-Specific IgE Assay is intended to aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The AP 3600 Automated Instrument is a software-enabled instrument designed for use with the OPTIGEN Allergen-Specific IgE Assay in clinical laboratories for sample processing, measurement analyses, and reporting of OPTIGEN Allergen-Specific IgE Assay results.

The AP 3600 Automated Instrument is a software-enabled instrument designed for use with the OPTIGEN Allergen-Specific IgE Assay in clinical laboratories for sample processing, measurement analyses, and reporting of OPTIGEN Allergen-Specific IgE Assay results.

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (AP3600 Automated Instrument). This type of document primarily confirms that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices.

The letter itself does not contain information about:

• Specific acceptance criteria for device performance.
• The details of a study (sample sizes, provenance, ground truth, expert qualifications, adjudication methods).
• Whether MRMC or standalone studies were performed.
• Training set details.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the studies, as this information is not present in the provided text. The document focuses on regulatory clearance, not detailed study results.

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