(33 days)
The Amylase Reagent is to be used in the assessment of pancreatitis.
Not Found
The provided text is related to a 510(k) clearance letter for an Amylase Reagent, an in vitro diagnostic device used for the assessment of pancreatitis. This type of document, particularly a 510(k) summary (which is not fully provided here but implied by the clearance letter), typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study description with acceptance criteria and device performance results as would be found in a clinical study report or a more comprehensive premarket approval (PMA) application.
Therefore, the requested information elements related to detailed study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not available in the provided document. The document states "we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This implies that the device's performance was compared to a legally marketed predicate device, and the specifics of that comparison, including the criteria and results, would be in the full 510(k) submission, not typically summarized in the clearance letter itself.
Given this, I cannot fill out the requested table and answer the specific questions about acceptance criteria and study details.
§ 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.