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The EUROIMMUN Anti-BP230-CF ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of immunoglobulin class IgG antibodies against BP230 in human serum and plasma (K3-EDTA, Li+heparin, Na+-citrate). It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.

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This FDA 510(k) clearance letter pertains to an In Vitro Diagnostic (IVD) device, specifically an ELISA test for autoantibodies. The provided text does not contain the kind of information typically associated with the development and validation of an AI/ML-based medical device, which would usually include details about:

• Algorithms and machine learning models
• Training and test datasets (sizes, provenance, ground truth establishment)
• Expert review processes (number of experts, qualifications, adjudication)
• MRMC studies or standalone AI performance metrics

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details based on the provided text.

The document describes the regulatory clearance for the EUROIMMUN Anti-BP230-CF ELISA (IgG) test kit, which is a laboratory assay.

Here's what can be extracted from the document:

• Device Name: EUROIMMUN Anti-BP230-CF ELISA (IgG)
• Regulation Number: 21 CFR 866.5660
• Regulation Name: Multiple autoantibodies immunological test system
• Regulatory Class: Class II
• Product Code: OEG
• Indications for Use: The test kit is intended for the qualitative or semi-quantitative determination of immunoglobulin class IgG antibodies against BP230 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.

To answer the detailed questions about acceptance criteria and study data for an AI/ML device, a different type of regulatory submission document (e.g., a summary of safety and effectiveness data or a clinical study report) would be required.

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