Intended Use

The kidneyintelX.dkd is for in-vitro diagnostic use for the determination of a kidneyintelX.dkd Level using an algorithm to combine clinical variables (blood urea nitrogen (BUN), hemoglobin A1c (HbA1c) and urine albumin creatinine ratio (UACR)) and the quantitative measurements of tumor necrosis factor receptor-1 (TNFR-1), tumor necrosis factor receptor-2 (TNFR-2) and kidney injury molecule-1 (KIM-1) in human plasma employing a Meso Sector S 600 electrochemiluminescence immunoassay. It is indicated for use as an aid in assessment of the risk of progressive decline in kidney function (sustained decrease in eGFR greater than or equal to 40% lasting more than 3 months) within a period of up to 5 years following kidneyintelX.dkd Level measurement in adult patients with type 2 diabetes and existing chronic kidney disease (defined for the purposes of this device as patients with an estimated glomerular filtration rate of 30-59 ml/min/1.73 m2 or eGFR ≥ 60 ml/min/1.73 m2 with albuminuria (UACR ≥ 30 mg/g)).

kidneyintelX.dkd is not intended for screening or as a stand-alone diagnostic test.

Warnings and Precautions

For Prescription Use Only.

Warning! Enbrel® interferes with the ability to accurately measure TNFR-2 in patient specimens and is contra- indicated for patients when ordering kidneyintelX.dkd testing.

Warning! Hemolyzed samples will not be analyzed. The kidneyintelX.dkd test result will not be generated.