VELO Respiratory Test

The VELO Respiratory Test is an automated rapid multiplex real-time RT-PCR test performed on the VELO Instrument for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus nucleic acid from anterior nasal swab specimens. It is intended for use as an aid in differential diagnosis in healthcare facilities operating under a CLIA Certificate of Waiver.

Key differences from the predicate (cobas SARS-CoV-2 & Influenza A/B) include: direct swab elution within the test cartridge rather than elution in transfer media; endogenous RNaseP sample process control instead of exogenous control; thermal lysis followed by direct RT-PCR amplification instead of automated silica magnetic particle extraction; SARS-CoV-2 second target in membrane protein gene rather than nucleocapsid protein gene; and results available in 10 minutes or less compared to approximately 20 minutes.

The document references ISO 13485 (quality management system), ISO 13484 clause 8.3 (nonconforming product), and ISO 13485 clause 8.5 (corrective and preventive action) as applicable regulatory standards. No specific consensus standards for test methodology (e.g., ASTM, IEC) are cited in the summary.

Substantial equivalence is established through: (1) identical intended use, regulatory class (Class II), and product code (QOF); (2) same assay technology (multiplexed PCR amplification with qualitative fluorescence detection); (3) same specimen type focus (anterior nasal swabs) and intended users (CLIA-waived healthcare facilities); and (4) rigorous analytical and clinical performance data demonstrating comparable or superior performance, with no safety or efficacy risks identified relative to the predicate despite technological differences.