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The ISE module of the DataPro™ Plus Clinical Chemistry Analyzer is intended for the quantitative determination of sodium, potassium and chloride in serum, using ion-selective (ISE) electrodes.

Sodium: Disorders of the sodium ion (Na ) can be caused by excessive loss, gain or retention of Na or excessive retention of water. Low Na * can be associated with renal failure, congestive heart failure and cirrhosis. An increase in Na+ is seen in neurological disorders such as tremors, ataxia, confusion and coma.

Potassium: Disturbances of potassium (K*) homeostasis has serious consequences and can lead to tachycardia when low. When high, respiratory weakness peripheral vascular collapse and cardiac arrest is evident. It is also seen in conditions associated with Addison's disease. Levels higher than 10mmol/L are fatal in most cases.

Chloride: When the chloride ion (CI) is unbalanced in the serum, it is usually a sign of an underlying disturbance in fluid and acid-base homeostasis. A low Cl" concentration is observed in individuals with salt-losing nephritis whereas an increase in Cl can indicate acute renal failure and metabolic acidosis.

The ISE module, and all of the reagents included in this test system are for in vitro diagnostic use only.

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The provided document is a 510(k) premarket notification letter from the FDA for a device called "ISE Module for the DataPro™ Plus". This document primarily communicates the FDA's decision regarding the substantial equivalence of the device to a predicate device and states that it can be marketed.

It briefly mentions the indications for use, but it does not contain information about acceptance criteria, detailed study design, device performance, sample sizes, ground truth establishment, or expert qualifications. The document is a regulatory approval letter, not a pivotal study report.

Therefore, I cannot provide the requested information based on the input text.

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