BioCode Gastrointestinal Pathogen Panel (GPP)

The BioCode Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test used with the BioCode MDx 3000 instrument to simultaneously detect and identify bacteria, viruses, and parasites from stool samples (unpreserved or Cary-Blair preserved). It detects 17 pathogens associated with gastrointestinal infection and is intended as an aid in diagnosis, with results to be used alongside other clinical and laboratory data.

The proposed device uses the same fundamental methodology as the predicate (multiplex RT-PCR with probe hybridization to barcoded magnetic beads and fluorescence detection), detects the same 17 pathogens with the same intended use, and is classified in the same regulatory category (Class II, 21 CFR 866.3990). The primary difference is expanded sample extraction compatibility: the proposed device supports easyMAG, MagNA Pure 96, KingFisher Flex, and KingFisher Apex Dx, whereas the predicate supported only easyMAG and MagNA Pure 96.

Not stated in this summary.

The applicant established substantial equivalence through comprehensive nonclinical reproducibility and limit-of-detection studies across all three extraction methods, plus clinical method-comparison studies using 468 archived specimens and 54 fresh specimens. The studies demonstrated ≥90% positive and negative percent agreement for nearly all targets when comparing the new extraction systems (KingFisher Flex and Apex Dx) to the predicate reference (easyMAG), with 95% confidence intervals supporting equivalence. The identical intended use, same pathogens detected, identical underlying assay methodology, and comparable analytical performance across extraction methods establish that the expanded extraction platform options do not compromise device safety or effectiveness relative to the predicate.