The FDA has allowed Beckman Coulter to continue selling its troponin test kits to customers currently using its Access instruments for as long as it takes Beckman to receive an updated 510(k) clearance for the tests.
Writing in an SEC filing today, Beckman also said "we will not be able to provide troponin test kits to US customers that are not currently performing troponin testing on Access instruments" until it obtains clearance.
In April the FDA said it believes Beckman made "certain modifications" to its troponin test, as used on Access immunoassay instruments, but that the company did not provide the agency "with an opportunity to review those modifications."
At that time, Beckman said it will remove the test kits from the US market on May 31.
In today's SEC filing, Beckman said it is "continuing our discussions with FDA and expect to implement a monitoring program to assure the performance of the test."
Reiterating comments it made last month, Beckman today said it plans to conduct a prospective clinical study and to submit two separate 510(k) submissions for our troponin test in the first half of 2011 — one for Access instruments and one for DxI instruments.
The study will be designed to establish the diagnostic performance of the test using patient samples from the intended use population. We are working collaboratively with FDA on a study protocol that will expedite the execution of the study.