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The IBL Acetylcholine Receptor Antibody (ARAb) Radio Receptor Assay is for the in-vitrodiagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma.

The ARAb Assay kit is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG).

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The provided document is a 510(k) premarket notification letter from the FDA to IBL-Hamburg GmbH regarding their IBL ARAb RRA Test Kit. This document formally approves the marketing of the device, stating it is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer the prompt.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC study details based only on the provided text.

The document primarily focuses on the regulatory aspects of the FDA's decision, such as:

• Device Name: IBL ARAb RRA Test Kit
• Regulation Number: 21 CFR 866.5660
• Regulation Name: Multiple autoantibodies immunological test system
• Regulatory Class: Class II
• Product Code: NST
• Indications For Use: The IBL Acetylcholine Receptor Antibody (ARAb) Radio Receptor Assay is for the in-vitro diagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma. The ARAb Assay kit is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG).

To provide the requested information, the actual 510(k) submission document, particularly the sections detailing the analytical and clinical performance studies, would be necessary.

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