(296 days)
The EasyRA sodium test is intended for the quantitative determination of sodium ions (Na+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. For in vitro diagnostic use only.
The EasyRA potassium test is intended for the quantitative determination of potassium ions (K+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only.
The EasyRA chloride test is intended for the quantitative determination of chloride ions (Cl) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For in vitro diagnostic use only.
The EasyRA carbon dioxide reagent is intended for the quantitative determination of Bicarbonate/Carbon Dioxide in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. For in vitro diagnostic use only.
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This document is a 510(k) premarket notification decision letter from the FDA for in vitro diagnostic devices (EasyRA Sodium, Potassium, Chloride, and Carbon Dioxide assays). It confirms substantial equivalence to predicate devices. However, it does not contain a study that proves the device meets acceptance criteria.
The letter itself states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This means the FDA has determined the new device is as safe and effective as a legally marketed predicate device, primarily based on the information provided by the applicant in their 510(k) submission. The letter does not include the details of the studies or acceptance criteria that were used within that submission.
Therefore, I cannot provide the requested information from the given text. To answer your questions, one would need to review the actual 510(k) submission document itself, which is not provided here.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.