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

Executive Summary

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.


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