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Abbott Glucose Test on i-STAT Alinity Gets FDA Clearance

NEW YORK (360Dx) – Abbott Laboratories recently received 510(k) clearance from the US Food and Drug Administration for its i-STAT Glucose test for use on the i-STAT Alinity System.

The test, a quantitative amperometric assay that measures glucose oxidase, had previously been cleared for use on other Abbott systems. 

In documents filed with the FDA, Abbott said that the glucose test on the Alinity platform is intended for use in the point-of-care or clinical laboratory setting, and for the quantitative measurement of glucose in arterial and venous whole blood. Glucose testing is used for diagnosing, monitoring, and treating carbohydrate metabolism disorders, including diabetes mellitus, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The test with the i-STAT Alinity platform has not been evaluated in neonates, Abbott said in the FDA document.