An amylase test system measures the amount of amylases in your blood or urine. It’s used to diagnose and monitor pancreatic disorders, salivary gland disorders, and other digestive conditions.

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Intended Use: It is used to detect amylase levels in human serum, plasma, or urine and to aid in the diagnosis and monitoring of pancreatitis, an inflammation of the pancreas. Elevated amylase levels, particularly in serum or urine, can indicate the presence of pancreatitis

Device description: Amylase is an enzyme that catalyzes the breakdown of starches into simpler sugars like maltose and glucose. It plays a crucial role in digestion, helping humans and animals break down carbohydrates. In industrial applications, amylase is used in food production, such as brewing, baking, and making corn syrup, to convert starch into fermentable sugars or modify starch properties. There are different types of amylases (alpha, beta, and gamma), each with specific functions. Amylase operates by lowering the activation energy needed for the hydrolysis of starch, making the process faster and more efficient.

• Linearity/assay reportable range
• traceability, Stability, Expected values (controls, calibrators, or methods)
• Detection limit
• Precision/Reproducibility
• Analytical specificity
• Assay Range

The same is applicable for CE Marking under IVDR also.

Not Applicable for 510k submission and IVDR CE Marking