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510(k) Data Aggregation
(258 days)
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
The Human α1-antitrypsin Kit for use on SPAPLUs is designed for the quantitative in vitro determination of a1-antitrypsin in human serum using the SPAPLus turbidimetric analyzer. The measurement of a1- antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a1- antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
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The provided document is a 510(k) clearance letter from the FDA for the "Human alpha-1 Antitrypsin Kit for use on SPAPLUS". It states that the device is substantially equivalent to a predicate device. However, it does not contain any information about the acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
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