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The Euro-Diagnostica Immunoscan MPO-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against myeloperoxidase to be used as an aid in the diagnosis of crescentic glomerulonephritis.

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I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Euro-Diagnostica Immunoscan Anti-Myeloperoxidase Antibodies (MPO-ANCA) Kit, stating its substantial equivalence to a predicate device.

While it mentions the "indications for use," it lacks specific details about:

• Acceptance Criteria: What quantitative or qualitative metrics the device needed to meet.
• Reported Device Performance: Actual sensitivity, specificity, accuracy, or other performance metrics from a study.
• Study Design Details: Sample sizes, data provenance, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, ground truth types, training set information, or how ground truth was established.

The document primarily confirms that the device is cleared for marketing based on its substantial equivalence to an existing device and specifies its intended use: "an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against myeloperoxidase to be used as an aid in the diagnosis of crescentic glomerulonephritis."

To provide the information you requested, I would need a different document, such as a summary of safety and effectiveness (SSE) from the 510(k) submission, clinical study reports, or a performance evaluation section.

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