(137 days)
The Amylase EPS Reagent is used for the quantitative determination of a-Amylase (1,4-α-D-glucan glucanohydrolase EC3.2.1.1) in human serum, plasma or urine on Beckman Coulter SYNCHRON CX ®/ LX ® Systems. a-Amylase is most frequently measured in the diagnosis of acute pancreatitis, when serum levels may be grossly elevated.
Amylase EPS Reagent
The provided text is a 510(k) premarket notification letter from the FDA to Thermo Fisher Scientific regarding the "Amylase EPS Reagent." This document confirms the substantial equivalence of the device to a legally marketed predicate device.
However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria. It is a regulatory approval letter, not a scientific study report.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and mentions the intended use of the reagent (quantitative determination of α-Amylase in human serum, plasma, or urine for diagnosis of acute pancreatitis), but it does not detail any performance metrics, study designs, sample sizes, or ground truth methodologies.
§ 862.1070 Amylase test system.
(a)
Identification. 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).(b)
Classification. Class II.