NEW YORK (GenomeWeb News) – Beckman Coulter today said that it anticipates filing for US clearance on its troponin test during May or June.
In a document filed with the US Securities and Exchange Commission, the Orange County, Calif.-based firm said that it plans to file two separate 510(k) applications with the FDA for the troponin test, one to be run on its Access instruments, the other on its Dxl instruments. Its time estimate is based on the current status of its clinical trial for the test, including site and patient enrolment, and preliminary myocardial infarction incidence rates observed.
Beckman Coulter had previously stated that it anticipated submitting to the FDA for the troponin test in the first half of this year.
The test had run into quality control problems a year ago when the company informed customers of a positive bias in results for its troponin test kits running on its UniCel Dxl immunoassay system.
Beckman Coulter is reportedly in the process of shopping for a buyer in a deal that could fetch $5 billion.