Trinity Pulls 510(k) For Troponin Point-Of-Care Test

04 Oct 2016

Trinity Biotech said US FDA may be expecting its point-of-care troponin assay to match the performance of laboratory-based systems and, as a result, it is withdrawing it its pending 510(k) submission. The firm said FDA has expressed concerns that the company's system has not met the agency's sensitivity threshold and is unable to operate in a wide enough temperature range.

Trinity Biotech PLC pulled a 510(k) submission for its Meritas Troponin-I Test and Meritas Point-of-Care Analyzer after FDA raised several concerns with the company at a Sept. 29 meeting. In doing so, the firm suggested that the US agency has recently moved the "goalpost" for point-of-care systems.

"It is our understanding that in order for any new point-of-care troponin product to obtain clearance, the FDA will require...