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The QIAstat-Dx Respiratory Panel Plus is a multiplexed nucleic acid test intended for use with the QIAstat-Dx system for the simultaneous in vitro qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infection, including SARS-CoV-2.

The following organism types and subtypes are identified using the QIAstat-Dx Respiratory Panel Plus: Adenovirus, Human Coronavirus 229E, Human Coronavirus HKU1, Human Coronavirus NL63, Human Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A H1, Influenza A H1N1 pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Respiratory Syncytial Virus, Human Rhinovirus/Enterovirus (not differentiated), Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2), Bordetella pertussis, Chlamydophila pneumoniae and Mycoplasma pneumoniae.

Nucleic acids from viral and bacterial organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. Detecting and identifying specific viral and bacterial nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical, epidemiological and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Negative results in the presence of a respiratory illness may be due to infection with pathogens that are not detected by the test or due to lower respiratory tract infection that is not detected by a NPS specimen.

Conversely, positive results are indicative of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the QIAstat-Dx Respiratory Panel Plus. The agent(s) detected by the QIAstat-Dx Respiratory Panel Plus may not be the definite cause of disease.

The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

The QIAstat-Dx Respiratory Panel Plus is part of the QIAstat-Dx system and works with the QIAstat-Dx Analyzer 1.0.

The QIAstat-Dx Respiratory Panel Plus is intended to be used with I nasopharyngeal swab (NPS) eluted in Universal Transport Media (UTM), which is not provided with the QIAstat-Dx Respiratory Panel Plus.

Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 1 hour. When the test is finished, the cartridge is removed by the user and discarded. The OIAstat-Dx Analyzer 1.0 automatically interprets test results and displays a summary on the analyzer display screen. The results can be printed using a connected printer if needed. The detected analytes are displayed in red. All other tested but not detected analytes are listed in green. The analyzer will report if an error occurs during processing, in which case the test will fail and no results will be provided (screen will show "FAIL").

All the reagents required for the complete execution of the test are pre-loaded and selfcontained in the QIAstat-Dx Respiratory Panel Plus cartridge. The user does not need to manipulate any reagents. During the test, reagents are handled by pneumatically-operated microfluidics without any direct contact with the user or the analyzer actuators.

Within the cartridge, multiple steps are automatically performed in sequence by using pneumatic pressure and a multiport valve to transfer sample and fluids via the Transfer Chamber (TC) to their intended destinations. Following the introduction of the sample from a disposable transfer pipette, the following assay steps occur automatically and sequentially:

• Resuspension of air-dried internal control and Proteinase K (ProtK) enzyme using ● provided buffer and mixing with the liquid sample (IC Cavity and ProtK Cavity);
• Cell lysis using mechanical (rotation) and chemical (chaotropic and isotonic) means ● (lysis chamber);
• Membrane based nucleic acid purification from Lysate by:
  • -Mixing lysate with binding buffer and capturing on the membrane (purification chamber);
  • First washing of membrane to remove bound proteins (purification chamber and waste chamber);
  • Second washing of membrane to leave only bound nucleic acids -(purification chamber and waste chamber);
  • -Rinsing of Transfer Chamber (TC) using the rinsing buffer before introduction of the eluate (Transfer Chamber);
  • Drying of membrane with bound nucleic acids with an air flow generated by a high flow vacuum pump (purification chamber);
  • -Elution of nucleic acids with elution buffer (purification chamber and TC);
• Mixing of the purified nucleic acid (eluate) with lyophilized "Master Mix" reagents (Dry chemistry container (DCC) and TC);
• Sequential transfer of defined aliquots of mixed eluate/Master Mix from the . Transfer Chamber to each of eight Reaction Chambers containing the specified, airdried primers and probes;
• Within each Reaction Chamber, real-time, multiplex PCR ("rtPCR") testing is . performed. Increase in fluorescence (indicative of detection of each target analyte) is detected directly within each Reaction Chamber;
• The detected signal per fluorescent marker per Reaction Chamber is then used by . the system software to generate the assay result.

The QIAstat-Dx Respiratory Panel Plus includes the addition of the SARS-CoV-2 analyte to the analytes that were cleared in the OIAstat-Dx Respiratory Panel (K183597).

The provided text describes the QIAstat-Dx Respiratory Panel Plus, a multiplexed nucleic acid test. The document focuses on demonstrating the substantial equivalence of this new device to a predicate device (BioFire Respiratory Panel 2.1 (RP2.1)), primarily by showing that the new device's SARS-CoV-2 detection is effective and that the addition of SARS-CoV-2 and a change in lysis reagent do not negatively impact the performance of other analytes previously cleared.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a single, concise list with specific thresholds (e.g., "PPA must be >X%"). Instead, they are implicitly demonstrated through performance goals such as high positive percent agreement (PPA) and negative percent agreement (NPA) compared to a comparator method, and meeting detection rates at defined LoD concentrations. For non-SARS-CoV-2 analytes, the criteria seem to be demonstrating equivalence to the previously cleared QIAstat-Dx Respiratory Panel (K183597).

Table of Acceptance Criteria (Implied) and Reported Device Performance

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • SARS-CoV-2 Clinical Performance: 616 prospective NPS specimens (615 included in analysis due to one exclusion).
     • Provenance: Collected from "five (5) geographically diverse study sites in the U.S.", indicating prospective data from multiple locations within the US. Collection period: February 2023 to May 2023 and during February 2024.
   • Representative Panel Equivalency (Non-SARS-CoV-2): 190 de-identified clinical NPS specimens.
     • Provenance: Clinical NPS specimens, both positive and negative as per Standard of Care. No specific country mentioned, but likely US given the overall context of FDA submission. "De-identified clinical NPS specimens" suggests retrospective collection but could also be prospective if de-identified at collection.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Clinical Performance (SARS-CoV-2): For SARS-CoV-2, the ground truth was established by comparing to "an FDA-cleared SARS-CoV-2 RT-PCR comparator method." This implies an established and validated laboratory method, not human expert consensus, for determining the presence or absence of the virus.
   • Representative Panel Equivalency: For the representative panel analytes, the comparison was against "Standard of Care" and by parallel testing with the "QIAstat-Dx Respiratory Panel" (the predicate device for these analytes). Again, this points to laboratory reference methods rather than human expert interpretation of imaging/clinical findings.
   • The document does not mention the use of human experts (e.g., radiologists) for establishing ground truth, as the device is an in-vitro diagnostic (IVD) for molecular detection, not an imaging AI.

3. Adjudication Method for the Test Set:

   • Clinical Performance (SARS-CoV-2): For discrepant results with the primary comparator for SARS-CoV-2, the text mentions that the "two samples with false negative SARS-CoV-2 results by the QIAstat-Dx Respiratory Panel Plus were both positive by two FDA-EUA molecular SARS-CoV-2 assays." Similarly, the "single sample with a false positive SARS-CoV-2 result...was positive by two FDA-EUA molecular SARS-CoV-2 assays." This indicates a form of adjudication by a secondary, independent highly sensitive molecular test (two FDA-EUA assays) to resolve discrepancies, providing a more robust ground truth.
   • Representative Panel Equivalency: No specific adjudication method is mentioned for this section beyond the direct comparison to "Standard of Care" and the QIAstat-Dx Respiratory Panel.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. An MRMC study is relevant for imaging devices where human readers interpret images. This device is an in-vitro diagnostic (IVD) for nucleic acid detection, performed automatically by an instrument. There are no human readers "interpreting" the output in a way that would necessitate an MRMC study.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Yes, the performance data (PPA, NPA, LoD, Analytical Reactivity, Specificity, Interference, Precision) are all reported as standalone performance of the QIAstat-Dx system. The system automatically interprets test results and displays a summary (page 6). This is an "algorithm only" performance in the context of an automated IVD test.

6. The Type of Ground Truth Used:

   • Lab-based Comparator Methods: For SARS-CoV-2 clinical performance, the ground truth was established using an "FDA-cleared SARS-CoV-2 RT-PCR comparator method" with further confirmation by "two FDA-EUA molecular SARS-CoV-2 assays" for discrepant results.
   • For the non-SARS-CoV-2 analytes, ground truth was derived from "Standard of Care" lab results and comparison to the "QIAstat-Dx Respiratory Panel" (the previously cleared device).
   • For analytical studies (LoD, inclusivity, specificity, etc.), ground truth was established by precise laboratory spiking of known concentrations of pathogens or interferents.
   • This is molecular/pathology-based ground truth, not outcomes data or expert consensus based on clinical or imaging findings.

7. The Sample Size for the Training Set:

   • The document does not provide information on the training set for the QIAstat-Dx Respiratory Panel Plus. This document is a 510(k) summary, which focuses on validation and demonstrated substantial equivalence to a predicate device. Information about the training data for the underlying assays or software algorithms is typically part of the device's development and design control documentation, which is not usually disclosed in a public 510(k) summary. The "device performance" described here refers to the testing of the final, developed device.

8. How the Ground Truth for the Training Set Was Established:

   • As the training set information is not provided, how its ground truth was established is also not detailed. In general, for molecular diagnostics like this, training data (if any specific to machine learning/AI components were used in the assay development) would typically involve well-characterized clinical samples or contrived samples with known pathogen presence/absence and concentration, verified by highly sensitive and specific reference methods (e.g., Sanger sequencing, quantitative PCR).

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