QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini

The QIAstat-Dx Respiratory Panel Plus and Panel Mini are multiplexed nucleic acid tests for simultaneous in vitro qualitative detection and identification of respiratory viral and bacterial nucleic acids in nasopharyngeal swabs from patients with respiratory tract infection symptoms, including SARS-CoV-2. The Panel Plus detects 21 targets (viruses and bacteria); the Panel Mini detects 5 viral targets. Results aid diagnosis when used with clinical and epidemiological findings but should not be the sole basis for diagnosis or treatment decisions.

Both panels use the same cartridge design, pneumatic microfluidics, membrane-based nucleic acid extraction via spin columns, and multiplex real-time RT-PCR detection with fluorescence-based readout. The key modification is the addition of the QIAstat-Dx Rise as an additional compatible instrument platform, which incorporates up to eight analytical modules on a small footprint with robotic cartridge handling and queuing capacity of 18 cartridges. The analytical modules used with Rise are identical to those in the Analyzer 1.0 and 2.0. Instructions for Use were updated with Rise-specific procedures; all other test characteristics remain unchanged.

Not stated in this summary.

The subject device is substantially equivalent because the QIAstat-Dx Respiratory Panels themselves are technologically and functionally identical to their predicates (K233100 and K242353), with only the addition of a compatible higher-throughput instrument platform. The panel cartridges, assay targets, specimen type, extraction method, amplification technology, and intended use remain unchanged. Analytical validation studies on the QIAstat-Dx Rise (equivalence at low analyte concentration, carryover, and reproducibility) demonstrate equivalent performance to the predicates, confirming that adding the Rise instrument does not alter test performance characteristics or patient safety and effectiveness profiles.