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FDA grants clearance to Home Diagnostics for pair of glucose meters


FORT LAUDERDALE, Fla. Home Diagnostics on Wednesday received 510(k) clearance from the Food and Drug Administration for the world’s smallest blood glucose meter, TRUE2go’, and for TRUEresult’, the company’s latest advanced performance, no-coding meter for at-home testing.

“Over the past three years we made capital investments in excess of $15 million in order to bring the TRUE2go and TRUEresult to market and are pleased to have FDA clearance for the new products,” stated Richard Damron, Jr., president and chief executive officer of Home Diagnostics. “Our new product platform is designed to fit people’s needs whether they are testing at home or on-the-go, making it easier for them to test accurately and quickly.”

TRUE2go is small enough to twist and attach to the top of a vial of test strips, offering patients a higher level of convenience for on-the-go testing.

Both new meters are compatible with the company’s new TRUEtest platform of blood glucose test strips featuring the company’s patent-pending GoldSensor’ laser accuracy and TRUEfill’ beveled tip. These features ensure highly accurate test results and first test success by allowing for greater sampling precision and consistency.

The new TRUE systems feature no-coding technology that simplifies blood glucose testing by eliminating the need for users to code the meter with each new box of test strips. Both TRUE2go and TRUEresult deliver results in as fast as four seconds using 0.5 microliters of blood.

TRUE2go and TRUEresult will be available in the fourth quarter of this year.

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