Unilife Corporation today announces that its Unitract Tuberculin (TB) Syringe has received 510(k) market clearance from the Food and Drug Administration (FDA).
The Unitract TB syringe is a variant of the Unitract 1mL Insulin Syringe for which Unilife secured FDA clearance earlier this year. Unlike insulin syringes which are primarily used by people with diabetes, TB syringes are used for the administration of a range of therapeutic drugs and vaccines within acute-care hospitals and other healthcare facilities.
The Unitract range of 1mL syringes is the world's first and only known syringe that allows operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place. The products are well positioned to help prevent the transmission of bloodborne pathogens such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse. Primary target markets of the products include healthcare facilities, pharmaceutical companies and patients who self-administer prescription medication. Production of the Unitract 1mL syringe is occurring at Unilife's FDA-registered manufacturing facility in Lewisberry, Pa.
Alan Shortall, CEO of Unilife, states, "U.S. FDA 510k market clearance for our Unitract TB syringe marks an important step in our company's efforts to bring a complete line of safety syringes to market, as it is our second product to receive this clearance. With TB syringes most commonly used within acute-care hospitals and other healthcare facilities, FDA clearance of our Unitract TB syringe significantly broadens our capacity to market our unique products across the U.S. and other key international markets."
Unilife has also recently secured its EC certification to apply the CE Mark to its Unitract 1mL syringes manufactured at its Lewisberry facility, allowing the sale and distribution of these products within the European Union and Australia.
The company also expects to complete studies required to attain a five-year shelf life expiration date for its full range of Unitract 1mL syringes in September. The inclusion of a five-year expiry date on medical device packaging is considered to be the gold-standard within the industry, and should help to finalize discussions with a number of interested U.S. healthcare distributors in the near future.