Siemens Healthineers Receives FDA Clearance for Blood Urea Nitrogen and Total C02 Point-of-Care Testing

Malvern, PA|02/02/2018

• Blood Urea Nitrogen and Total Carbon Dioxide testing at the point of care improve patient care with results in less than a minute.
• Renal injury and metabolic diseases are common among critically ill patients who benefit from immediate results.

Siemens Healthineers announced today it has received 510(k) clearance from the U.S. Food and Drug Administration for its Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2) point-of-care tests to aid in the diagnosis of renal diseases and metabolic imbalances. These assays expand precision medicine performed at the patient-side to enable faster clinical decision making.

In its continued effort to improve patient care, Siemens Healthineers now can provide a full menu on a single test card within the blood analysis market for clinicians to perform at the patient bedside on the handheld epoc® Blood Analysis System. A broad menu benefits clinical service lines that routinely perform blood analysis, including critical care units, the emergency department, radiology, cardiac catheterization labs and out-patient centers.

“With the epoc system, these new assays will expand the patient information clinicians can access sooner to help rule in or rule out potential diagnoses more quickly,” said Michael Sampson, Senior Vice President, Point of Care Diagnostics, North America, Siemens Healthineers. “Rapid, informed diagnoses and treatment decisions at the patient-side ultimately aids in improving clinical outcomes.”

BUN—combined with creatinine and an estimated glomerular filtration rate (eGFR)—also available on the epoc system—can aid in the differential diagnosis of renal and metabolic diseases. TCO2—with other parameters that comprise a basic metabolic panel currently available at the point of care from Siemens Healthineers—can aid clinicians in assessing acid base and metabolic imbalances and make changes in therapy where necessary.

The epoc® Blood Analysis System delivers a full menu of results, including pH, partial pressure of oxygen, partial pressure of carbon dioxide, sodium, potassium, ionized calcium, hematocrit, glucose, lactate, creatinine, chloride, and soon BUN and TCO2, in less than a minute. Results are easily integrated into any Laboratory Information System.

Learn more about the epoc Blood Analysis System and BGEM Test Card.

Contact for journalists
Kimberly Nissen, Siemens Healthineers
Phone: +1 610 448-6355; Email:

Siemens Healthineers is the separately managed healthcare business of Siemens AG enabling healthcare providers worldwide to achieve better outcomes at lower costs by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience and digitalizing healthcare. A leader in medical technology, Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services. In fiscal 2017, which ended on September 30, 2017, Siemens Healthineers generated revenue of €13.8 billion and profit of €2.5 billion and has about 48,000 employees worldwide. Further information is available at