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This assay is designed for the in vitro quantitation of a-1 Antitrypsin in serum using the Minineph®, as an aid in the diagnosis of several conditions, including juvenile and adult cirrhosis of the liver. In addition, a-1 Antitrypsin deficiency has been associated with pulmonary emphysema.

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This is a medical device approval letter and Indications for Use statement for the Minineph® α-1 Antitrypsin Antiserum. Therefore, it does not contain information about a study proving the device meets acceptance criteria in the way you've outlined. This document is a regulatory approval, not a clinical study report.

Here's why I cannot fulfill your request with the provided input:

• No Study Described: The document is a 510(k) clearance letter from the FDA. It states that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA has determined it's safe and effective based on its similarity to existing, approved products, rather than requiring new, extensive clinical trials for this specific version.
• No Acceptance Criteria: The letter refers to regulatory compliance and substantial equivalence, not specific performance acceptance criteria for a clinical study.
• No Performance Data: There are no tables of device performance, sample sizes, ground truth information, or details about study design (retrospective/prospective, MRMC, standalone).

To answer your request, I would need a clinical study report or a summary of performance data for the Minineph® α-1 Antitrypsin Antiserum. This document merely confirms its regulatory clearance.

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