FilmArray GI Control Panel M238

The FilmArray GI Control Panel M238 is an external quality control material consisting of two liquid controls (M239 and M240) containing synthetic RNA transcripts for 22 gastrointestinal pathogens including bacteria, viruses, and parasites. It is designed to monitor the performance of the BIOFIRE FILMARRAY Gastrointestinal Panel and Panel Mid assays on BIOFIRE FILMARRAY systems.

Both the candidate and predicate devices are ready-to-use liquid controls containing synthetic RNA transcripts suspended in non-infectious buffers, preservatives, and stabilizers. Both are processed like patient samples and monitor the same assay steps (reverse transcription, amplification, detection, identification) on BIOFIRE FILMARRAY 2.0 and Torch systems. The candidate targets 22 gastrointestinal pathogens while the predicate targets 23 respiratory pathogens.

21 CFR 866.3920 (Assayed Quality Control Material For Clinical Microbiology Assays) is cited as the applicable regulation; no consensus standards (ISO, IEC, ASTM) are referenced in this summary.

The device demonstrates substantial equivalence through identical physical format, composition, and functional design to the predicate device. Testing of 165 samples across 2 sites, 20 reagent lots, 9 operators, and multiple instruments yielded 100% correct results with zero invalid tests, showing the candidate performs as reliably as the predicate despite targeting a different pathogen panel. The manufacturing process, assay mechanism, and intended use as an external quality control for a specific BIOFIRE assay are functionally equivalent.