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news.Trinity Biotech, a developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, has filed its 510k submission with the FDA for its new high throughput coagulation analyzer, the Destiny Max.
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Trinity has recently obtained CE marking which enables it to sell the Destiny Max in Europe and has now filed its 510k submission with the FDA seeking permission to sell the instrument in the US.
The target market for the instrument in both markets includes university hospitals, high throughput general hospitals, high volume commercial laboratories and reference laboratories.
Ronan O’ Caoimh, CEO of Trinity Biotech, said: “Filing the 510k with the FDA is the last step in the launch of our new high throughput coagulation platform, the Destiny Max. Our goal is to have the Max approved by the FDA during the second quarter of 2009.