(396 days)
The EasyRA Alkaline phosphatase (ALP) reagent is intended for the quantitative determination of alkaline phosphatase in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases. For in vitro diagnostic use only.
The EasyRA Aspartate Aminotranferase (AST) reagent is intended for the quantitative determination of the enzyme Aspartate Aminotranferase in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of alkaline phosphatase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. For in vitro diagnostic use only.
The EasyRA Amylase (AMY) reagent is intended for the quantitative determination of amylase in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. a-Amylase in serum/plasma is used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) and other pancreatic disorders. For in vitro diagnostic use only.
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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them in the format you requested. The document is a 510(k) clearance letter from the FDA for several "EasyRA" reagents. It focuses on the substantial equivalence determination and the indications for use of these diagnostic reagents.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, training sets, or how ground truth was established for these.
- Information on the number or qualifications of experts used for ground truth, or adjudication methods.
- Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
The document is a regulatory approval, not a scientific study report. Therefore, I cannot fulfill your request based on the provided input.
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.