Vitamin D Linearity Test Gets Nod
Maine Standards Company received FDA clearance to market its Validate Vit D linearity test kit. The liquid, ready-to-use kit is designed for use on all major manufacturers' clinical laboratory instruments for verifying vitamin D calibration.
FDA Recommends Lower Risk Classification for Certain TB Tests
FDA issued a proposal rule on lowering the classification for certain tuberculosis (TB) tests. Specifically, FDA wants to reclassify nucleic acid-based tests that detect TB from Class III (high-risk) to Class II (moderate-risk). According to the agency, the proposed rule would encourage the development of nucleic acid-based tests for TB and allow manufacturers to use a faster, more streamlined clearance pathway for medical devices. FDA is seeking input on the proposed rule for 90 days.
Quidel's Influenza A+B Assay Cleared
Quidel received FDA clearance for its Quidel Molecular Influenza A+B assay for use with the Cepheid SmartCycler polymerase chain reaction (PCR) system. This product is one of several assays from Quidel's expanding molecular diagnostics programs that features simple transport and storage, and generates results quickly.
FDA Issues Guidance on Considerations Used in Device Approval
FDA released a guidance document for medical device manufacturers describing how the benefits and risks of certain medical devices are considered during pre-market approval (PMA) review. The guidance outlines the systematic approach FDA device reviewers take when making benefit-risk determinations. It also offers manufacturers a helpful tool explaining the various factors considered by the agency during the review of PMA applications, and describes an approach that takes into account patients' tolerance for risks and perspectives on benefits, as well as the novelty of the device. See the complete document online.
Test for Viruses Linked to Leukemia, Neurologic Diseases Approved
Avioq Inc., received FDA approval to market its Avioq HTLV-I/II Microelisa System, a test designed to detect antibodies to viruses in donors of human blood and blood components that are associated with several diseases, including some forms of leukemia and neurologic diseases. Avioq HTLV-I/II Microelisa System can be used to both screen the blood supply for antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and Human T-Lymphotropic Virus Type II (HTLV-II) and help diagnose infection with these viruses.
Clearance for Group B Strep Assay
Becton Dickinson received FDA clearance to market its BD Max Group B Streptococcus (GBS) Assay designed to detect GBS DNA in Lim Broth cultures. The test runs on the company's second-generation BD Max System and received a CLIA moderate complexity test categorization. According to BD, the test is the only automated in vitro diagnostic method with a moderate complexity categorization that uses the polymerase chain reaction to detect GBS from Lim Broth.
Quest’s C. difficile Test Cleared
Quest Diagnostics received FDA clearance to market its Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler. Developed by Quest's wholly owned business Focus Diagnostics, the test is designed to aid in the diagnosis of C. difficile infections. Simplexa tests use real-time polymerase chain reaction to qualitatively detect viruses, bacteria, and other analytes. The C. difficile test also uses proprietary chemistry to eliminate nucleic acid extraction. The test uses liquid or unformed stool samples to detect the toxin B (tcdB) gene of C. difficile.