(16 days)
For the quantitative determination of Alkaline Phosphatase in serum. For IN VITRO diagnostic use. Elevated alkaline phosphatase activity in serum is of interest in the diagnosis of several disease conditions including hepatobiliary disease and bone disease associated with increased osteoblastic activity. Alkaline phosphatase activity in serum may be elevated due to obstructive jaundice, occlusion of the common bile or hepatic duct, and cirrhosis.
Alkaline Phosphatase-SL Assay
The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the "Alkaline Phosphatase-SL Assay" device. These documents pertain to an in vitro diagnostic assay, not an AI/ML-powered device.
Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) regarding an AI/ML device is not applicable to this submission. The documents describe a laboratory assay for measuring alkaline phosphatase levels, which is a chemical test, not a software-based diagnostic tool.
§ 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.