FDA 510(k) clearance for first-of-its-kind high-throughput diagnostic test for infectious vaginitis. BD (Becton Dickinson and Company)
-BD (Becton, Dickinson and Company) announced that it has received 510(k) clearance from the FDA for the BD Vaginal Panel on the BD COR System, a comprehensive diagnostic test that directly detects the three most common infectious causes of vaginitis using BD's high-throughput molecular diagnostic platform for large laboratories.
BD Vaginal Panel on the BD COR System is a comprehensive diagnostic test that directly detects the three most common infectious causes of vaginitis using BD’s high-throughput molecular diagnostic platform for large laboratories.
This 510(k) clearance for the BD Vaginal Panel on the BD COR System is the first high-throughput version of the test. Accurate diagnosis of BV, VVC and TV is critical to ensuring appropriate treatment regimens and decreasing the risk of associated complications and resistance to treatment. Using a single test can also help reduce the need for repeat testing unnecessary use of treatments and lower the risk of contracting STIs.
If a test is positive for VVC (commonly referred to as a "yeast infection"), the BD Vaginal Panel is the only FDA-cleared Nucleic Acid Amplification Test (NAAT) that provides separate results for C. glabrata and C. krusei — two Candida species that are known to carry resistance to traditional antimicrobials — to ensure proper treatments are prescribed.
The availability of the BD Vaginal Panel on the automated BD COR System in the U.S. reflects BD's commitment to expand the menu of available assays for women's health and other infectious diseases.
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