(206 days)
The N-Assay TIA Alpha-l-Antitrypsin Test Kit is intended for the quantification of human alpha-l-antitrypsin in human serum by immunoturbidimetric assay. The measurement of of alpha-lantitrypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition. alpha-l-antitrypsin deficiency has been associated with pulmonary emphysema.
Not Found
The provided document is an FDA 510(k) clearance letter for the N-Assay TIA Alpha-1-Antitrypsin Test Kit. It states that the device is substantially equivalent to a predicate device for the quantification of human alpha-1-antitrypsin in human serum. As such, the document does not contain specific acceptance criteria, a study design, or performance data for this device.
The information typically requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not part of this type of regulatory letter. This letter confirms regulatory clearance, not the detailed technical validation study.
Therefore, I cannot provide the requested information from the given text.
§ 866.5130
Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).