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BD Nabs 510(k) and CLIA Waiver for Veritor Strep Diagnostic

Feb. 26, 2014

BD Diagnostics said Tuesday it has received FDA 510(k) clearance and a CLIA waiver for the BD Veritor System for rapid detection of group A streptococcus, the most common bacterial cause of sore throat.

According to Alberto Mas, president of BD Diagnostics – Diagnostic Systems, the BD Veritor System demonstrated “proven performance” compared with bacterial culture methods and delivered results in about eight minutes. The test also allows more accuracy in determining the etiology of pharyngitis, enabling doctors to make more appropriate antibiotic treatment decisions, the company said.

Used in conjunction with the hand-held BD Veritor System reader, the assay utilizes advanced nanoparticle and adaptive read technologies to obtain accurate, objective results. The reader’s digital display “offers healthcare professionals a new option for group A strep testing versus current visual read CLIA-waived assays,” BD said, adding the new test is the only CLIA-waived group A strep test to incorporate a digital display.

CLIA refers to the 1988 Clinical Laboratory Improvement Amendments, which set federal standards for U.S. facilities that deal with human test specimens.

The new assay is cleared for use in hospitals, outpatient clinics and other patient-care settings. — Nick Otto

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