(70 days)
The EasyRA Magnesium Reagent is for the in-vitro quantitative measurement of magnesium in serum on the Medica EasyRA analyzer. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders. For in vitro diagnostic use only.
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This document is a 510(k) clearance letter from the FDA for a medical device called "Magnesium EasyRA Reagent." It indicates that the device has been found substantially equivalent to a legally marketed predicate device. The information provided is primarily regulatory in nature and does not contain details about specific acceptance criteria or a study proving the device meets them.
Therefore, I cannot provide the requested information based on the provided text. The document states the device name, intended use, and regulatory classification but lacks specific performance metrics, study designs, sample sizes, or ground truth establishment relevant to the questions asked.
§ 862.1495 Magnesium test system.
(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.