Epocal, a provider of point of care technology, has received FDA clearance to market its new lactate test on the enterprise point of care (epoc) Blood Analysis System. The test further expands clinical utility of epoc System for point-of-care blood analysis.
The lactate measurements from the epoc System are used to evaluate acid-base status and for diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
The addition of lactate to the epoc BGEM Test Card, which includes in vitro diagnostic tests for pH, pO2, pCO2, Na, K, iCa, Hct and Glu (plus calculated values), further expands the clinical utility of the company’s point of care blood gas and electrolyte platform.
Epocal claimed that the lactate on the BGEM Test Card represents the second metabolite cleared for use on the epoc System in the past 12 months. It is also the ninth measured analyte on the single-use test card, surpassing most competitive point of care systems which may require multiple test devices in order to match the same menu.
The epoc system is marketed co-exclusively by Epocal and Alere in all geographies worldwide, except for Japan, India, Nepal, Bhutan and Sri Lanka.
Imants Lauks, inventor and CEO of Epocal, said: “Epocal reaffirms its commitment to patient care by adding this critical test to its cost effective, comprehensive point of care platform. The epoc technology continues to excite healthcare with its ability to improve delivery of patient care, reduce operating expenses and increase efficiency throughout the entire healthcare enterprise.”