(69 days)
The test system will be used in laboratories to separate serum ALP isoenzymes. Elevated bone isoenzyme can be found in conditions of physiologic bone growth, metastatic carcinoma and as rickets. Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver. Intestinal isoenzymes can be seen in patients with intestinal disease in particular after a meal. Intestinal Isoenzymes occur in blood type O or B after a meal.
Not Found
This document is a 510(k) clearance letter from the FDA for the SPIFE 2000/3000 ALP device. It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria.
The letter states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices. This determination is based on a comparison to existing devices, not on a new study providing specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. The document is primarily an administrative letter confirming regulatory clearance.
§ 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.