BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid is an automated, qualitative nucleic acid-based diagnostic test that detects and identifies 11 gastrointestinal pathogens (bacteria, viruses, and parasites) directly from stool samples in Cary Blair transport media. Results are available in approximately one hour and are intended to aid in diagnosing gastrointestinal infections in symptomatic individuals, used alongside other clinical and laboratory data.

The device uses nested multiplex PCR followed by high-resolution melt curve analysis to detect target sequences. It is identical to the predicate BIOFIRE GI Panel in technology, instrumentation (BIOFIRE FILMARRAY 2.0 or TORCH System), sample preparation, reagent storage, controls, and time-to-result. The only modification is software that masks and reports only 11 of the original 22 analytes instead of the full panel.

Not stated in this summary.

The BIOFIRE GI Panel Mid is substantially equivalent because it is physically and functionally identical to the predicate BIOFIRE GI Panel (K242367), differing only in software masking that restricts the reported analyte menu from 22 to 11 targets. The performance data presented—including sensitivity, specificity, limit of detection, reproducibility, and exclusivity—was established during the original predicate's clinical and analytical evaluations and remains valid since the underlying technology, instrumentation, and assay chemistry are unchanged. The software modification has been verified and validated to demonstrate no change in safety and effectiveness.