Xpert Xpress CoV-2/Flu/RSV plus

The Xpert Xpress CoV-2/Flu/RSV plus is an automated real-time RT-PCR test that simultaneously detects and identifies SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) from nasopharyngeal or anterior nasal swab specimens. It is performed on Cepheid GeneXpert Dx and GeneXpert Infinity systems and aids in diagnosing COVID-19, influenza, and RSV infections in patients with respiratory symptoms.

The device uses the same real-time reverse transcription polymerase chain reaction (RT-PCR) detection technology, automation platform, and identical assay targets as the predicate device. Both employ GeneXpert instrument systems with the same software platforms and achieve results in approximately 36 minutes or less. The only technical modifications are parameter setting changes in the Assay Definition File (ADF): turning off Signal Loss Detection (SLD) for the Flu B channel and revising the result reporting algorithm for SARS-CoV-2 only test mode.

Not stated in this summary.

The device is substantially equivalent because it shares the same regulation classification, product code, specimen types, transport media, assay targets, internal controls, and technological platform as the predicate device (K231481). Although the ADF parameter settings were modified, re-analysis of 15,645 analytical test results and 9,525 clinical/precision test results demonstrated that the numbers of valid test runs and non-determinate results were identical between the original and updated designs, with all performance claims remaining unaffected. The algorithm change for SARS-CoV-2 only mode was verified to produce expected results under simulated test conditions, confirming that the modifications do not raise different questions of safety and effectiveness.