Osmetech plc, the international diagnostics group, is pleased to announce that it has received 510k pre-marketing approval from the US Food & Drug Administration (FDA) for its OPTI LION portable electrolyte analyser.

The OPTI LION, together with the OPTI R blood gas and electrolyte analyser with reusable consumable designed for higher volume users, was successfully exhibited at the American Association of Clinical Chemists Conference (AACC) in Orlando, US in July this year.

This latest approval completes all the regulatory requirements necessary to market and sell both products in the US.

James White , Chief Executive of Osmetech plc said, ‘The shipment of existing orders will commence next month and we look forward to continuing the roll out of both products around the world through our established international distribution network.

‘These two products further strengthen the OPTI product portfolio and should allow us to accelerate the growth of instrument placements throughout the world, with proprietary consumable revenues continuing for a number of years to come.’

Product details

Osmetech OPTI R analyser : Based upon Osmetech’s well established and successful Critical Care Analyser (CCA), this enables customers to perform up to 50 tests from a single consumable over a 7 day period.

Osmetech OPTI LION is a maintenance free low cost instrument for electrolyte and pH testing in near patient care settings using dry chemistry optical fluorescence sensors.

For further enquiries contact:
 
Matthew Moth +44 (0)20 7378 7033
madano partnership