FDA News

Trinity Biotech Files 510k for Destiny Max With FDA

(Dec 24, 2008)--Trinity Biotech, developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced the filing of its 510k submission with the FDA for its new high throughput coagulation analyzer, the Destiny Max.

Trinity 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 United States. The target market for the instrument in both markets includes university hospitals, high throughput general hospitals, high volume commercial laboratories and reference laboratories.

Commenting on the filing Ronan O' Caoimh, CEO, said, "Filing the 510k with the FDA is the last step in the launch of our new high throughput coagulation platform, the Destiny Max. 2008 has been an eventful year for our coagulation business and we have now rationalised our three coagulation brands (Biopool, Amax and bioMerieux) into the new Trini brand, we have successfully completed the integration of the bioMerieux business from North Carolina to our coagulation manufacturing facility in Ireland, and we have now launched the Destiny Max. Our goal is to have the Max approved by the FDA during quarter 2 of 2009. In the meantime we are actively demonstrating the instrument to potential customers in the USA and are receiving excellent feedback from all customers. Sales outside the USA have already begun with the first instruments being shipped to Japan, Italy and Ireland this month and with initial sales to the UK expected in January. We are extremely confident that we now have all the tools in place to seriously challenge the competition in this US$1 billion market."

For further information please see the Company's website: www.trinitybiotech.com.

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