Beckman to Submit Troponin Assay for 510(k) Clearance in Early 2011

May 14, 2010

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Beckman Coulter, emerging from month-long discussions with FDA over the regulatory fate of its troponin assay, today said it expects to submit the test for 510(k) clearance in the first half of 2011.

Writing in an SEC filing released this morning, the company said it expects to submit separate 510(k) applications for the DxI and Access instruments on which the assay is run.

"FDA has recently provided guidance on the type of information required to be included in a 510(k) submission as well as the goal of any clinical studies for troponin," Beckman said in the filing.

Among those requirements is "a prospective clinical study for 510(k) clearance of all troponin tests going forward and we are implementing their guidance."

The 510(k) clearance process can take between three and 12 months.

Today's update comes one month after Beckman said it will remove the troponin test kits from the US market on May 31 after FDA told it that "certain modifications to our troponin test kits, as used on our DxI systems as well as used on our Access systems, were made without obtaining appropriate product clearances from the agency."

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