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Randox Laboratories Limited Pancreatic α - Amylase (Ethylidene Blocked - pNPGyme Colorimetric Test) is an in vitro diagnostic reagent for the quantitative ermination of pancreatic α - amylase in serum and urine samples. This test kit measures pancreatic isoamylase and therefore has greater clinical specificity for the diagnosis of creatic disorders when compared to total amylase assessment. This test kit must be d by suitable qualified laboratory personnel under appropriate laboratory conditions.

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The provided documents are a letter from the FDA regarding a 510(k) premarket notification for a device called "Pancreatic α - amylase" and a "Indications For Use" form. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The letters primarily state that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory conditions for its marketing. The "Indications For Use" form describes the device's intended use as an in vitro diagnostic reagent for quantitative determination of pancreatic α-amylase in serum and urine samples, highlighting its specificity for diagnosing pancreatic disorders compared to total amylase assessment.

Therefore, I cannot provide the requested information based on the given input.

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