(31 days)
Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers.
Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Amylase Reagent" device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The letter primarily:
- Confirms that the device is substantially equivalent to a legally marketed predicate device.
- Outlines the regulatory requirements for the device.
- Grants permission to market the device.
- Provides contact information for regulatory inquiries.
The "Indications for Use" section (Page 2 of the original document) states: "Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers. Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas)."
However, no specific performance metrics like sensitivity, specificity, accuracy, precision, or recovery are mentioned, nor is there any description of a study conducted to demonstrate these. Therefore, I cannot extract the requested information regarding acceptance criteria or a study from this document.
§ 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.