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The SPIFE A1AT kit is designed for the qualitative detection of the different phenotypes of Alpha-1 Antitypsin (Al AT). Phenotyping results in conjunction with clinical findings and other laboratory assays aid in the diagnosis of Alpha-1 Antitrypsin deficiency. The analysis is performed on human sera separated into electrophoretic patterns ready for qualitative analysis. The procedure includes isoelectrofocusing on agarose gel, performed on the semiautomatic SPIFE Touch system followed by immunofixation with anti-Alpha-1 Antiserum. For in vitro diagnostic use only.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the SPIFE A1AT kit does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The document is a clearance letter stating that the device is substantially equivalent to a predicate device and outlines general regulatory requirements. It does not include the specifics of the performance study, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, or data provenance.
• Details about expert involvement in ground truth establishment or adjudication methods.
• Information on MRMC studies or effect sizes.
• Whether standalone performance was evaluated.
• The type of ground truth used.
• How ground truth was established for the training set.

To obtain this information, you would typically need to refer to the 510(k) summary or the full 510(k) submission for the device, which are often available through the FDA's public databases or directly from the manufacturer. The clearance letter itself only confirms the regulatory approval.

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