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# Beckman Coulter Troponin Assay Cleared
- URL: https://www.fdaweb.com/beckman-coulter-troponin-assay-cleared/
- Published: 2018-06-27T12:00:00.000Z
- Updated: 2026-09-15T00:16:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141781

FDA has cleared a Beckman Coulter Diagnostics 510(k) for its new high-sensitivity troponin assay, Access hsTnI, for use on the Access 2, DxI and all Access immunoassay systems. The assay is intended to detect troponin I, a protein that is present in circulation during myocardial infarction. The test is designed to enable clinical laboratories to confidently report accurate results from plasma or serum samples for clinical decision making in the acute-care setting, according to the company.