DEVICE: kidneyintelX.dkd Test (00860009877924)

An in vitro diagnostic interpretive software program intended to be used in the assessment of risk of progression of chronic kidney disease (CKD). It uses specific algorithms to combine and correlate patient demographics, clinical observations, and the in vitro diagnostic results of the qualitative and/or quantitative detection of one or multiple chronic kidney disease biomarkers in a clinical specimen to establish an individual risk score that may be used to guide patient management to minimise progression to kidney failure and dialysis.

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple non-genetic markers associated with chronic kidney disease (CKD), [e.g., tumour necrosis factor receptor-1 (TNFR-1), tumour necrosis factor receptor-2 (TNFR-2), kidney injury molecule-1 (KIM-1), blood urea nitrogen (BUN), haemoglobin A1c (HbA1c), albumin and creatinine ration (UACR)] in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to determine the risk of kidney function decline in patients with chronic illness e.g., type 2 diabetes and/or CKD. It is not intended to be used for routine kidney function testing.