FDA Clears Siemens Healthineers’ Blood Urea Nitrogen and Total CO2 Point-of-Care Testing

Siemens Healthineers announced 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 glomular 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.