This assay has been cleared by the FDA for use on serum samples. ARUP has validated it for use on I.V. fluid specimens. This test is intended to provide an estimate of the insulin concentration in I.V. fluid samples for medical purposes. Accuracy of the result may be decreased in the presence of high insulin concentrations and/or other substances present in the I.V. fluid. Please note that the result is in units of µIU/mL. To convert an Insulin I.V. fluid result to IU/mL, divide the results in µIU/mL by 1,000,000.
Compliance Statement B
: This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.