QIAstat-Dx GI Panel 2 Mini B

The QIAstat-Dx GI Panel 2 Mini B is a multiplexed nucleic acid test that detects and identifies five bacterial pathogens (Campylobacter, Shigella, Shiga-like toxin E. coli, Salmonella, and Yersinia enterocolitica) directly from preserved stool samples using the QIAstat-Dx Analyzer 1.0. It is intended as an aid in diagnosing gastrointestinal bacterial infections in individuals with signs and symptoms of gastroenteritis.

The device is physically identical to the predicate QIAstat-Dx Gastrointestinal Panel 2 but uses a modified Assay Definition File (ADF) that masks all but five bacterial targets from the full panel. Both use the same PCR-based detection technology, silica membrane nucleic acid extraction, internal controls, and QIAstat-Dx Analyzer 1.0 instrument; the Mini B version detects only DNA rather than RNA/DNA.

Not stated in this summary.

Substantial equivalence is supported because the QIAstat-Dx GI Panel 2 Mini B shares identical technological design, reagent chemistry, extraction methodology, amplification technology, and instrument platform as the predicate device. The only modification is the ADF software masking, which has been verified and validated to demonstrate no change in safety or effectiveness. The performance data for the five reported analytes is equivalent to the corresponding subset of targets in the predicate device, and all operational and specimen handling procedures remain unchanged.