www.fdanews.com/articles/187408-beckman-coulter-gains-clearance-for-troponin-assay
![ClearanceStamp_Orange.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Orange.gif?t=1609798625&width=430)
Beckman Coulter Gains Clearance for Troponin Assay
June 28, 2018
The FDA granted 510(k) clearance for Beckman Coulter Diagnostics’ high-sensitivity troponin (hsTnl) assay for detecting troponin, a protein present in circulation during myocardial infarction.
The assay, which is unique due to its use of plasma and serum samples, allows laboratories to report results for clinical decision making in the acute-care setting.
The assay gives clinicians insights on cardiac conditions for patients with chest pain and helps them diagnose myocardial infarction.