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This Human C1 Inactivator kit for use on SPAPLUS is intended for the in vitro measurement of human C1 inactivator in human serum using the SPAPLUS Analyzer. Measurement of C1 inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.

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The provided document is an FDA 510(k) clearance letter for an in vitro diagnostic device, the "Human C1 Inactivator Kit for use on SPAPLUS." It does not contain any information about the acceptance criteria or study details for proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary (which is a separate document).

The letter primarily confirms that the FDA reviewed the premarket notification and determined the device is substantially equivalent to a legally marketed predicate device. It defines the device name, regulation number, regulation name, regulatory class, and product codes. It also outlines responsibilities of the manufacturer regarding general controls, labeling, and reporting.

Therefore, I cannot provide the requested information based on the given text. The text does not include:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test or training sets, nor data provenance.
• Details about experts for ground truth establishment or adjudication methods.
• Information on MRMC studies or standalone algorithm performance.
• The type or establishment method of ground truth.

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