BioCode® Respiratory Pathogen Panel (RPP)

The BioCode Respiratory Pathogen Panel (RPP) is a qualitative multiplexed nucleic acid-based diagnostic test that simultaneously detects and identifies 17 viral and bacterial pathogens (including influenza, RSV, coronaviruses, parainfluenza, adenovirus, rhinovirus/enterovirus, and three bacterial species) from nasopharyngeal swab specimens. Results are available within approximately 5 hours and are intended to aid in diagnosing respiratory tract infections when used with clinical and epidemiological information.

The proposed device uses the KingFisher Flex extraction system in addition to the previously cleared easyMAG and MagNA Pure 96 systems. The internal control cut-off value increased from 8,000 MFI (predicate) to 13,000 MFI (proposed). All other technological characteristics—including the multiplex RT-PCR methodology, barcoded magnetic bead detection, BioCode MDx-3000 instrumentation, turnaround time, and pathogen panel composition—remain identical to the predicate device.

Not stated in this summary.

Substantial equivalence is established because the proposed device has identical intended use, same regulatory classification, same fundamental technology platform (multiplex RT-PCR with barcoded magnetic bead detection), and detects the same pathogens as the predicate device K192485. Non-clinical reproducibility and limit-of-detection studies plus clinical method comparison studies (testing 735 archived samples with 95.5% positive agreement and 99.8% negative agreement) demonstrate performance equivalence with the predicate, despite the addition of the KingFisher Flex as an alternative extraction method.