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Siemens Healthineers Receives FDA Clearance for Epoc BUN, TC02 Tests

NEW YORK (GenomeWeb) – Point-of-care tests from Siemens Healthineers to measure blood urea nitrogen (BUN) and total carbon dioxide (TCO2) have been granted 510(k) clearance by the US Food and Drug Administration.

The tests run on the firm's handheld Epoc blood analysis system and are intended for use in the diagnosis of kidney diseases and metabolic imbalances. Siemens acquired the Epoc system from Abbott last year as part of its purchase of the Epocal division of Abbott subsidiary Alere.

The BUN and TCO2 tests will be added to the Epoc system test card, which also includes assays for pH, partial pressure of oxygen, partial pressure of carbon dioxide, sodium, potassium, ionized calcium, hematocrit, glucose, lactate, creatinine, and chloride. The test card provides results in about one minute and can also be integrated into laboratory information systems, the company said.

Siemens Healthineers also suggested that a broad menu of tests benefits clinical areas that routinely perform blood analysis, such as critical care units, emergency departments, 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," Michael Sampson, the company's senior VP of point-of-care diagnostics in North America, said in a statement. "Rapid, informed diagnoses and treatment decisions at the patient-side ultimately aids in improving clinical outcomes."