(28 days)
Intended for the In Vitro, quantitative determination of Amylase in human serum and urine for clinical diagnosis.
"This 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)". , CFR 862.1070
TRACE Amylase - DST Reagent
The provided documents are a 510(k) premarket notification letter from the FDA for a device called "TRACE Amylase - DST Reagent." This is not a study report or clinical trial document for a medical AI/ML device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and the study proving the device meets them.
The 510(k) letter confirms that the device is "substantially equivalent" to predicate devices already on the market, meaning it has similar indications for use and technological characteristics. It does not elaborate on specific performance data or studies beyond stating that a review was conducted.
To answer your questions, I would need a document that describes a clinical or analytical study performed to evaluate the performance of an AI/ML medical device, including acceptance criteria and results.
§ 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.