Xpert GI Panel

The Xpert GI Panel is a qualitative multiplexed nucleic acid test performed on Cepheid GeneXpert Instrument Systems that simultaneously detects and identifies DNA and RNA from 11 gastrointestinal pathogens (bacteria, parasites, and viruses) directly from stool samples in Cary Blair transport media. Results are available in approximately 74 minutes and are intended for use in individuals with signs and symptoms of gastrointestinal infection.

The subject device uses nested multiplex real-time reverse transcription polymerase chain reaction (RT-qPCR) with detection by amplification and melt curve analysis, compared to the predicate's nested multiplex RT-PCR followed by high resolution melting analysis. Both are automated systems with qualitative results, but the subject device targets the same 11 analytes and uses similar specimen type (stool in Cary Blair media) and test format (single-use disposable cartridge).

Not stated in this summary.

The Xpert GI Panel is substantially equivalent to the predicate FilmArray GI Panel because both are Class II multiplex nucleic acid-based assays for detecting the same gastrointestinal pathogens from stool in Cary Blair media, use similar automated detection and interpretation methods, and demonstrate comparable analytical performance (sensitivity, specificity, reproducibility) and clinical performance across all 11 target analytes with positive and negative percent agreements exceeding 90% for most analytes.