Trinity Biotech announces withdrawal of Troponin FDA 510(k) Submission
Trinity Biotech announced that it is withdrawing its 510(k) premarket notification submission for the Meritas Troponin-I Test and Meritas Point-of-Care Analyzer. The company held a meeting with the FDA on Thursday September 29, in order to obtain an update on the company's Meritas Troponin submission. At this meeting the FDA asked Trinity to consider withdrawing their submission, due to some concerns they have about the submission. Their primary concerns relate to the device's operating temperature range and that the Troponin-I clinical performance is not consistent with the clinical performance data presented by the most recently cleared laboratory Troponin device. "Whilst we believe that the Meritas product demonstrates excellent performance for a point-of-care product and is superior to all existing point-of-care Troponin products in the market, we decided yesterday to withdraw the submission. Over the coming weeks we will engage with the FDA to gain a better understanding of the nature of their concerns. However, it is our understanding that in order for any new point-of-care Troponin product to obtain clearance, the FDA will require it to demonstrate performance equivalent to the most recently cleared laboratory based device. Our decision to withdraw is based on the fact that, notwithstanding its excellent performance characteristics, we believe that there is no certainty that this level of performance can be achieved by the Meritas product even with the benefit of further development efforts," the company said.