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QIAstat-Dx Respiratory Panel Plus:

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 infections, including Severe Acute Respiratory Syndrome Coronavirus 2 (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 A H3, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Respiratory Syncytial Virus, Human Rhinovirus/Enterovirus (not differentiated), 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 presence 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.

QIAstat-Dx Respiratory Panel Mini:

The QIAstat-Dx Respiratory Panel Mini 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 nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infections, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

The following viruses are identified using the QIAstat-Dx Respiratory Panel Mini: Influenza A, Influenza B, Respiratory Syncytial Virus, Human Rhinovirus, and SARS-CoV-2.

Nucleic acids from viral organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. Detecting and identifying specific viral 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 presence of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the QIAstat-Dx Respiratory Panel Mini. The agent(s) detected by the QIAstat-Dx Respiratory Panel Mini 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 and the QIAstat-Dx Respiratory Panel Mini are multiplexed nucleic acid tests which are designed for use with the QIAstat-Dx system (currently QIAstat-Dx Analyzer 1.0 and QIAstat-Dx Analyzer 2.0). The device modification is to add the QIAstat-Dx Rise as an additional instrument for use with the QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Respiratory Panel Mini ("QIAstat-Dx Respiratory Panels"). The QIAstat-Dx Rise is a higher throughput platform, incorporating up to eight QIAstat-Dx Analytical Modules (AM) on a small footprint. The instrument allows queuing up to 18 cartridges, which are scheduled for processing and delivered to the appropriate AM by an integrated robotic handler. The AM used with the QIAstat-Dx Rise is the same AM that can be used with the QIAstat-Dx Analyzer 1.0 or 2.0.

The modified QIAstat-Dx Respiratory Panel Plus and QIAstat-Dx Respiratory Panel Mini are identical to the QIAstat-Dx Respiratory Panel Plus (K233100) and the QIAstat-Dx Respiratory Panel Mini (K242353), respectively, with the exception of the Instructions for Use which were updated to include the assay-specific procedure for the QIAstat-Dx Rise.

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

All the reagents required for the complete execution of the test are pre-loaded and self-contained in a QIAstat-Dx Respiratory Panel 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 the 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 Internal Control
• Cell lysis using mechanical and/or chemical means
• Membrane-based nucleic acid purification
• Mixing of the purified nucleic acid with lyophilized master mix reagents
• Transfer of defined aliquots of eluate/master mix to different reaction chambers
• Performance of multiplex real-time RT-PCR testing within each reaction chamber

The QIAstat-Dx Respiratory Panel Assay Definition File (ADF) automatically interprets test results and displays a summary on the instrument display screen. The detected analytes are displayed in red. All other tested but not detected analytes are listed in green. The instrument 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").

The provided text describes a 510(k) premarket notification for the QIAstat-Dx Respiratory Panel Plus and QIAstat-Dx Respiratory Panel Mini, with a modification to include the QIAstat-Dx Rise instrument. The key takeaway from this document is that the FDA determined the device is substantially equivalent to previously cleared devices. Therefore, the "acceptance criteria" discussed here refer to the demonstration of equivalence to a predicate device, rather than specific performance metrics against a clinical ground truth for a new device.

Here's an analysis based on your questions:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for a modification to an already cleared device, the acceptance criteria are not explicitly stated in terms of clinical performance numbers (e.g., sensitivity, specificity). Instead, the acceptance criteria are focused on demonstrating that adding the new instrument (QIAstat-Dx Rise) does not negatively impact the performance, and that the new system is "substantially equivalent" to the predicate devices.

The "reported device performance" is essentially that the studies "successfully demonstrated the equivalent performance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the test set used in the "Equivalence at Low Analyte Concentration," "Carryover," or "Reproducibility" studies. It also does not mention the data provenance (country of origin, retrospective or prospective). These details would typically be found in the actual study reports, which are not included in this FDA clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable or provided in this document. For an in vitro diagnostic device like this, ground truth for clinical performance would typically be established by comparing against FDA-cleared or gold standard laboratory methods (e.g., culture, sequencing, or other highly sensitive PCR assays) rather than expert consensus on imaging or clinical findings. Since this submission focuses on establishing equivalence and not initial clinical performance, such details are not expected.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and would not typically be part of a 510(k) clearance letter for an IVD device unless specific clinical adjudication was required for complex diagnostic outcomes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The QIAstat-Dx Respiratory Panels are automated in vitro diagnostic devices for detecting nucleic acids. They do not involve human readers' interpretation of images or other data in a way that would necessitate an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is an in vitro diagnostic test. It is inherently a "standalone" system in its operation, as the instrument performs the test and provides a result. There is no mention of a human-in-the-loop component beyond loading the sample and reading the final result from the display screen. The device's "algorithm" (i.e., the assay's detection mechanism and interpretation software) operates without human intervention once the run starts.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the "ground truth" used for the analytical studies (Equivalence at Low Analyte Concentration, Carryover, Reproducibility). For such studies, the ground truth would be established by controlled laboratory experiments, where samples with known concentrations of analytes are used, and the assay's results are compared against these known inputs. For initial clinical performance, the ground truth would typically be a highly sensitive and specific reference method, but those studies are for the predicate devices, not this modification.

8. The sample size for the training set

This information is not provided. Training sets are typically associated with machine learning or AI models. While instruments like the QIAstat-Dx have underlying algorithms, they are based on established PCR principles and assay design, not a machine learning training paradigm in the way AI image analysis would be.

9. How the ground truth for the training set was established

This information is not provided and is not applicable for this type of IVD device in the context of a 510(k) modification for instrument compatibility.

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The OlAstat-Dx Respiratory Panel Mini is a multiplexed nucleic acid test intended for use with the OlAstat-Dx system for the simultaneous in vitro qualitative detection of multiple respiratory viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infections, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

The following viruses are identified using the OlAstat-Dx Respiratory Panel Mini: Influenza B. Respiratory Syncytial Virus, Human Rhinovirus, and SARS-CoV-2.

Nucleic acids from viral organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. Detecting and identifying specific viral 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 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 QlAstat-Dx Respiratory Panel Mini. The agent(s) detected by the QlAstat-Dx Respiratory Panel Mini 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 Mini (Cat. no. 691218) assay is a modified device (reduced version) of the QIAstat-Dx Respiratory Panel Plus (Cat. no. 691224). The QIAstat-Dx Respiratory Panel Mini is identical to the QIAstat-Dx Respiratory Panel Plus (K233100) with the exception of the labeling and Assay Definition File (ADF), which masks all but five pathogens (targets) from the QIAstat-Dx Respiratory Panel Plus. The following viruses are identified using the OlAstat-Dx Respiratory Panel Mini: Influenza A, Influenza B, Respiratory Syncytial Virus, Human Rhinovirus, and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The OIAstat-Dx Respiratory Panel Mini is part of the QIAstat-Dx system and works with the QIAstat-Dx Analyzer 1.0.

The QIAstat-Dx Respiratory Panel Mini 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 Mini.

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 QlAstat-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 Mini 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 Internal Control ●
• Cell lysis using mechanical and/or chemical means ●
• Membrane-based nucleic acid purification ●
• . Mixing of the purified nucleic acid with lyophilized master mix reagents
• Transfer of defined aliquots of eluate/master mix to different reaction chambers
• Performance of multiplex real-time RT-PCR testing within each reaction chamber. ●

The provided text describes the QIAstat-Dx Respiratory Panel Mini, a molecular diagnostic device, and its substantial equivalence to a predicate device (QIAstat-Dx Respiratory Panel Plus). However, the document does not contain specific acceptance criteria, detailed results of a study proving those criteria were met, or information on aspects like sample size, data provenance, expert ground truth establishment, or clinical study methods typically associated with AI/imaging device validation.

The text states that "The performance data for the QIAstat-Dx Respiratory Panel Mini is equivalent to the QIAstat-Dx Respiratory Panel Plus (K233100) with the exception it only includes data for the five analytes detected by the QIAstat-Dx Respiratory Panel Mini (Influenza A, Influenza B, Respiratory Syncytial Virus, Human Rhinovirus, and Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2). Please see the Qiagen QIAstat-Dx Respiratory Panel Mini Instructions for Use for performance tables." This indicates that the detailed performance data and acceptance criteria would be found in the device's Instructions for Use, which is not included in the provided document.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested level of detail. The document primarily focuses on establishing substantial equivalence to a predicate device by noting that the "Mini" version is a "reduced version" of the "Plus" version, masking certain pathogens through a software update (Assay Definition File).

Here's what can be inferred and what is missing, based on your request and the provided text:

Inferences (based on typical diagnostic device clearance and the nature of the device):

• Device Type: The QIAstat-Dx Respiratory Panel Mini is an in vitro diagnostic (IVD) device, specifically a multiplexed nucleic acid test. It detects viral nucleic acids (RNA/DNA) directly. This is not an AI-based imaging device, and therefore, many of the requested criteria (like number of experts, MRMC studies, human reader improvement with AI, etc.) are not applicable to this type of device.
• Acceptance Criteria (Implied): For a molecular diagnostic test, acceptance criteria typically revolve around metrics like:
  • Sensitivity: The ability of the test to correctly identify positive samples (true positive rate).
  • Specificity: The ability of the test to correctly identify negative samples (true negative rate).
  • Limit of Detection (LoD): The lowest concentration of an analyte that can be reliably detected.
  • Cross-reactivity: Ensuring the test does not falsely detect non-target organisms.
  • Reproducibility/Precision: Consistency of results when tested multiple times under various conditions.
  • Interference: Lack of impact from common substances found in clinical samples.
    The text states the performance is "equivalent" to the predicate, implying these types of criteria were met.
• Study Proving Acceptance Criteria: The study would be a clinical performance study and potentially analytical performance studies comparing the device's results against a known reference method or clinical consensus. The document references the "Instructions for Use for performance tables," which would contain these details.

Addressing Your Specific Points (based only on the provided text):

1. A table of acceptance criteria and the reported device performance:

   • Not provided in the text. The text refers to the "Instructions for Use for performance tables" for this information.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided in the text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable for this type of molecular diagnostic device in the same way it would be for an AI-based imaging device. Ground truth for molecular tests is typically established through a combination of:
     • Reference molecular methods: Highly sensitive and specific laboratory-developed tests or other cleared/approved molecular tests.
     • Clinical diagnosis: A combination of patient signs, symptoms, clinical course, and results from other diagnostic tests.
     • Culture: For some pathogens, though molecular tests often have higher sensitivity.
   • The document implies ground truth was established to demonstrate "equivalence" of the five remaining analytes, but no specifics are given.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. This is relevant for subjective assessments like imaging interpretation. For molecular diagnostics, discrepancies are typically resolved through re-testing, using an orthogonal method, or clinical correlation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, this was not done. This is an IVD device, not an AI-assisted imaging device. Human "readers" (interpreters) are not involved in the direct output of this automated molecular test; results are automatically interpreted by the analyzer.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, in spirit. A molecular diagnostic test like this is inherently a "standalone" algorithm in a lab setting. The device automatically processes the sample and interprets results. While lab personnel initiate the test and retrieve results, there isn't a "human-in-the-loop" subjective interpretation component as there would be with an AI imaging system. The performance of the device is what's evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated in the provided text. For molecular diagnostics, ground truth often involves a combination of:
     • Comparator molecular methods (e.g., PCR assays with known performance).
     • Clinical diagnosis and follow-up (for some studies).
     • Sequencing (for definitive identification of viral strains).

8. The sample size for the training set:

   • Not provided in the text. This device isn't explicitly described as having a "training set" in the context of an AI model that learns from large datasets. It's a biochemical/molecular assay with a fixed set of reactions and an "Assay Definition File (ADF)" that controls which stored results are displayed. The "training" would be more akin to assay development and optimization, rather than machine learning training.

9. How the ground truth for the training set was established:

   • No "training set" for an AI model is described. Assay development and optimization would rely on characterized positive and negative control materials, and potentially spiked samples, to establish performance parameters.

Summary of what the document does tell us about the "study":

The core of the documentation provided is a claim of substantial equivalence (510(k) clearance) based on the QIAstat-Dx Respiratory Panel Mini being a modified version of a previously cleared device, the QIAstat-Dx Respiratory Panel Plus (K233100).

• Modification: The "Mini" version is simply the "Plus" version with a software change (Assay Definition File - ADF) that masks the results for all but five specific pathogens.
• Proof: The manufacturer validated and verified this software change to demonstrate "there is no change in safety and effectiveness" for the five remaining analytes compared to their performance on the predicate device. This means the underlying assay chemistry and detection capabilities for those five analytates are presumed to be identical.
• Conclusion: Because the underlying technology and performance characteristics for the detected analytes are identical to a previously cleared device, and the only change is the masking of additional targets, the FDA determined Substantial Equivalence without requiring a full de novo performance study for the entire device. Performance data for the five analytes from the predicate device's clearance would implicitly serve as the basis for the "Mini" version.

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