QIAstat-Dx GI Panel 2 Mini B&V

The QIAstat-Dx GI Panel 2 Mini B&V is a nucleic acid test that detects five gastrointestinal pathogens (Norovirus, Campylobacter, Shigella, STEC, and Salmonella) from preserved stool samples using the QIAstat-Dx Analyzer 1.0. It provides qualitative detection and identification of nucleic acids to aid in diagnosing gastrointestinal infections, with results available in approximately 78 minutes.

The device is identical to the predicate QIAstat-Dx Gastrointestinal Panel 2 in all technological aspects: same PCR-based amplification and detection technology, same silica membrane nucleic acid extraction, same QIAstat-Dx Analyzer 1.0 instrument, and same internal control strategy. The only difference is a modified Assay Definition File (ADF) that masks 11 targets from the predicate's 16 targets, reporting only the 5 analytes in the Mini B&V panel.

Not stated in this summary.

The QIAstat-Dx GI Panel 2 Mini B&V shares identical platform technology, instrumentation, sample processing, nucleic acid extraction methodology, and detection chemistry with the predicate device. The five analytes it reports are a subset of the predicate's 16 targets, and performance data for these five analytes are equivalent to those already demonstrated for the predicate. The only modifications are labeling changes and an ADF software change verified and validated to mask unreported targets without altering safety or effectiveness of the reported analytes.