LEX Diagnostics Submits FDA 510(k) Clearance and CLIA Waiver Applications for LEX VELO System (clinicallab.com)

• LEX Diagnostics submits 510(k) and CLIA waiver applications.
• Applications come under FDA's final LDT rule.
• LEX VELO positioned as point-of-care platform.

"LEX Diagnostics has submitted dual applications to the US FDA for 510(k) clearance and a CLIA waiver for its LEX VELO diagnostic system. The submission highlights the regulatory compliance landscape shaped by the FDA's final rule on laboratory-developed tests (LDTs), which imposes additional requirements on laboratories operating under CLIA/CAP. The outcome of these applications could set precedents for point-of-care diagnostic devices and their regulatory pathway. The article notes the increased compliance burden for metabolomics laboratories."