September 2011 Clinical Laboratory News: News from the FDA

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Clearance for Luminex’s Respiratory Viral Panel Test

FDA has cleared Luminex Corporation’s xTAG Respiratory Viral Panel FAST (RVP FAST) test for market. The xTAG RVP FAST assay tests for multiple viral strains and subtypes that cause respiratory viral infections, including respiratory syncytial virus, influenza A, non-specific influenza A, H1 subtype, H3 subtype, influenza B, metapneumovirus, adenovirus, and entero-rhinovirus. The test gives labs the ability to rapidly provide actionable patient results to physicians.

Siemens Test Earns Pulmonary Embolism Exclusion for POC

Siemens has received FDA clearance to market its D-dimer assay for the company’s Stratus CS Acute Care Diagnostic System. The test allows physicians to exclude pulmonary embolism in conjunction with a non-high clinical pretest probability assessment model at the point-of-care (POC). This is the only test available in the U.S. to achieve this clinical validity for use in the POC setting.

Agency Releases Draft Guidance on 510(k) Program

FDA has issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission. According to the agency, the draft guidance was written to better explain the kinds of changes that call for a new submission, such as specific kinds of labeling changes, changes to the technology used in the device, changes in performance specifications, manufacturing changes, and changes in the materials used in the manufacture of the device. FDA officials issued the draft guidance as one of its 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations launched in 2011 to improve predictability, consistency, and transparency of the agency’s parametric review programs. “We are making the regulatory process for medical devices less challenging by better describing our expectations,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Manufacturers can continue to make innovative improvements to their devices.” Go to FDA’s CDRH site to see the draft guidance.
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