QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

The QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx GI Panel 2 Mini B&V, and QIAstat-Dx GI Panel 2 Mini B are multiplexed nucleic acid tests for simultaneous in vitro qualitative detection and identification of viruses, bacteria, and/or parasites directly from preserved stool samples. The devices are intended for use with the QIAstat-Dx Analyzer 2.0 and the newly added QIAstat-Dx Rise instrument for diagnosing specific agents of gastrointestinal infection in individuals with signs and symptoms.

The devices use PCR-based amplification and detection with fluorescence-based real-time RT-PCR technology. All reagents are pre-loaded and self-contained in cartridges with pneumatically operated microfluidics. Nucleic acid extraction uses silica membrane-based purification. The key modification is the addition of the QIAstat-Dx Rise, a higher-throughput platform with up to eight analytical modules on a small footprint, capable of processing up to 16 cartridges. The analytical modules used with Rise are identical to those used with the QIAstat-Dx Analyzer 2.0.

Not stated in this summary.

The modified devices are substantially equivalent because they maintain identical technological characteristics, indications for use, specimen types, amplification and detection technology, assay controls, nucleic acid extraction methods, and assay targets as the predicate device (K252329). The only difference is the addition of the QIAstat-Dx Rise as an alternative instrument platform. Analytical studies performed on the Rise—including equivalence at low analyte concentration, carryover, and reproducibility testing—demonstrate equivalent performance to the predicate devices.