QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
Applicant
QIAGEN GmbH
Product Code
QOF · Microbiology
Decision Date
Aug 27, 2025
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.3981
Device Class
Class 2
Indications for Use
The 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. The 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 (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 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 Mini. 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.
Device Story
QIAstat-Dx system performs multiplexed RT-PCR for respiratory pathogen detection; includes QIAstat-Dx Analyzer 1.0, 2.0, and new QIAstat-Dx Rise instrument. QIAstat-Dx Rise is high-throughput platform; uses integrated robotic handler to process up to 18 cartridges across eight analytical modules. Cartridges are single-use; contain all reagents for nucleic acid extraction, amplification, and detection. User loads NPS specimen into cartridge; system performs automated sample prep, lysis, purification, and real-time PCR. Fluorescence signals indicate presence of specific viral/bacterial targets. Results displayed on screen; aids clinicians in diagnosing respiratory infections alongside other clinical findings. Benefits include rapid turnaround (~1 hour) and minimal hands-on time.
Clinical Evidence
Bench testing only. Reproducibility study across three sites, five days, three operators, and three reagent lots demonstrated acceptable performance. Instrument equivalency study compared QIAstat-Dx Rise to QIAstat-Dx Analyzer 1.0 using serial dilutions of representative analytes; results confirmed equivalent hit rates and Ct values. Carry-over study confirmed no cross-contamination during automated robotic handling.
Technological Characteristics
Multiplexed real-time RT-PCR; cartridge-based; automated pneumatic microfluidics for sample prep, lysis, and purification. QIAstat-Dx Rise platform features robotic handler and eight analytical modules. Connectivity: Standalone instrument system. Software: Automated interpretation via Assay Definition File (ADF).
Indications for Use
Indicated for individuals with clinical signs/symptoms of respiratory tract infection. Uses nasopharyngeal swabs (NPS) for qualitative detection/identification of viral and bacterial nucleic acids (Plus panel) or viral nucleic acids (Mini panel) including SARS-CoV-2. Not for sole diagnostic use.
Regulatory Classification
Identification
A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: Analytes and targets the device detects and identifies, the specimen types tested, the results provided to the user, the clinical indications for which the test is to be used, the specific intended population(s), the intended use locations including testing location(s) where the device is to be used (if applicable), and other conditions of use as appropriate.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed descriptions of the performance characteristics of the device for each specimen type claimed in the intended use based on analytical studies including the following, as applicable: Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, precision, reproducibility, and clinical studies;
(iii) Detailed descriptions of the test procedure(s), the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) A warning statement that viral culture should not be attempted in cases of positive results for SARS-CoV-2 and/or any similar microbial agents unless a facility with an appropriate level of laboratory biosafety (
*e.g.,* BSL 3 and BSL 3+, etc.) is available to receive and culture specimens; and(v) A prominent statement that device performance has not been established for specimens collected from individuals not identified in the intended use population (
*e.g.,* when applicable, that device performance has not been established in individuals without signs or symptoms of respiratory infection).(vi) Limiting statements that indicate that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) There is a risk of incorrect results due to the presence of nucleic acid sequence variants in the targeted pathogens;
(D) That positive and negative predictive values are highly dependent on prevalence;
(E) Accurate results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(F) When applicable (
*e.g.,* recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer-reviewed literature), that the clinical performance may be affected by testing a specific clinical subpopulation or for a specific claimed specimen type.(4) Design verification and validation must include:
(i) Detailed documentation, including performance results, from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, as appropriate, additional characterized clinical samples. The clinical study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained using a comparator that FDA has determined is appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses.
(ii) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as Failure Modes Effects Analysis and/or Hazard Analysis. This documentation must include a detailed description of a protocol (including all procedures and methods) for the continuous monitoring, identification, and handling of genetic mutations and/or novel respiratory pathogen isolates or strains (
*e.g.,* regular review of published literature and periodic in silico analysis of target sequences to detect possible mismatches). All results of this protocol, including any findings, must be documented and must include any additional data analysis that is requested by FDA in response to any performance concerns identified under this section or identified by FDA during routine evaluation. Additionally, if requested by FDA, these evaluations must be submitted to FDA for FDA review within 48 hours of the request. Results that are reasonably interpreted to support the conclusion that novel respiratory pathogen strains or isolates impact the stated expected performance of the device must be sent to FDA immediately.(iii) A detailed description of the identity, phylogenetic relationship, and other recognized characterization of the respiratory pathogen(s) that the device is designed to detect. In addition, detailed documentation describing how to interpret the device results and other measures that might be needed for a laboratory diagnosis of respiratory infection.
(iv) A detailed device description, including device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including molecular target(s) for each analyte, design of target detection reagents, rationale for target selection, limiting factors of the device (
*e.g.,* saturation level of hybridization and maximum amplification and detection cycle number, etc.), internal and external controls, and computational path from collected raw data to reported result (*e.g.,* how collected raw signals are converted into a reported signal and result), as applicable.(v) A detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review.
(vi) For devices intended for the detection and identification of microbial agents for which an FDA recommended reference panel is available, design verification and validation must include the performance results of an analytical study testing the FDA recommended reference panel of characterized samples. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(vii) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens, the design verification and validation must include a detailed description of the identity, phylogenetic relationship, or other recognized characterization of the Influenza A and B viruses that the device is designed to detect, a description of how the device results might be used in a diagnostic algorithm and other measures that might be needed for a laboratory identification of Influenza A or B virus and of specific Influenza A virus subtypes, and a description of the clinical and epidemiological parameters that are relevant to a patient case diagnosis of Influenza A or B and of specific Influenza A virus subtypes. An evaluation of the device compared to a currently appropriate and FDA accepted comparator method. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(5) When applicable, performance results of the analytical study testing the FDA recommended reference panel described in paragraph (b)(4)(vi) of this section must be included in the device's labeling under § 809.10(b) of this chapter.
(6) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens in addition to detection of SARS-CoV-2 and similar microbial agents, the required labeling under § 809.10(b) of this chapter must include the following:
(i) Where applicable, a limiting statement that performance characteristics for Influenza A were established when Influenza A/H3 and A/H1-2009 (or other pertinent Influenza A subtypes) were the predominant Influenza A viruses in circulation.
(ii) Where applicable, a warning statement that reads if infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to State or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
(iii) Where the device results interpretation involves combining the outputs of several targets to get the final results, such as a device that both detects Influenza A and differentiates all known Influenza A subtypes that are currently circulating, the device's labeling must include a clear interpretation instruction for all valid and invalid output combinations, and recommendations for any required followup actions or retesting in the case of an unusual or unexpected device result.
(iv) A limiting statement that if a specimen yields a positive result for Influenza A, but produces negative test results for all specific influenza A subtypes intended to be differentiated (
*i.e.,* H1-2009 and H3), this result requires notification of appropriate local, State, or Federal public health authorities to determine necessary measures for verification and to further determine whether the specimen represents a novel strain of Influenza A.(7) If one of the actions listed at section 564(b)(1)(A) through (D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those influenza viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized influenza viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's labeling required under § 809.10(b) of this chapter that accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that accompanies the device, prominently providing a hyperlink to the manufacturer's public website where the analytical reactivity testing data can be found. The manufacturer's website, as well as the primary part of the manufacturer's website that discusses the device, must provide a prominently placed hyperlink to the website containing this information and must allow unrestricted viewing access.
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K250080
B Applicant
Qiagen GmbH
C Proprietary and Established Names
QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QOF | Class II | 21 CFR 866.3981 - Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The SARS-CoV-2 Respiratory Infection And Other Microbial Agents When In A Multi-Target Test | MI - Microbiology |
## II Submission/Device Overview:
### A Purpose for Submission:
The purpose of this submission is to modify the previously cleared QIAstat-Dx Respiratory Panel Plus (K233100) and the QIAstat-Dx Respiratory Panel Mini (K242353), to add the QIAstat Dx Rise instrument.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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B Measurand:
The QIAstat Respiratory Panel Plus detects and identifies nucleic acids from the following pathogens:
- Severe Acute Respiratory Syndrome (SARS)-Coronavirus-2 (SARS-CoV-2) [RNA-dependent-RNA-polymerase gene (RdRp) & Envelope protein gene (E)]
- Adenovirus [Hexon gene]
- Human Coronavirus 229E [Membrane protein gene (M)]
- Human Coronavirus HKU1 [Nucleocapsid protein gene (N)]
- Human Coronavirus NL63 [Nucleocapsid protein gene (N)]
- Human Coronavirus OC43 [Nucleocapsid protein gene (N)]
- Human Metapneumovirus A+B [A/B Nucleoprotein gene (N)]
- Influenza A [Matrix gene (M)]
- Influenza A H1 [Hemagglutinin gene (HA)]
- Influenza A H1N1 pdm09 [Neuraminidase gene (NA)]
- Influenza A H3 [Hemagglutinin gene (HA)]
- Influenza B [Nucleoprotein gene (M)]
- Parainfluenza virus 1 [Hemagglutinin-neuraminidase glycoprotein gene (HN)]
- Parainfluenza virus 2 [Hemagglutinin-neuraminidase glycoprotein gene (HN)]
- Parainfluenza virus 3 [Phosphoprotein gene (P)]
- Parainfluenza virus 4 [Nucleocapsid protein gene (N)]
- Respiratory Syncytial Virus A+B [Matrix protein gene (M)]
- Rhinovirus/Enterovirus* [5'-UTR region]
- Bordetella pertussis [Transposase Insertion Sequence (IS481)]
- Chlamydophila pneumoniae [Major outer membrane protein gene (ompA)]
- Mycoplasma pneumoniae [Cytadhesin gene (P1)]
*Both Rhinovirus and Enterovirus are detected but not differentiated.
The QIAstat Respiratory Panel Mini detects and identifies nucleic acids from the following pathogens:
- Severe Acute Respiratory Syndrome (SARS)-Coronavirus-2 (SARS-CoV-2) [RNA-dependent-RNA-polymerase gene (RdRp) & Envelope protein gene (E)]
- Influenza A [Matrix gene (M)]
- Influenza B [Nucleoprotein gene (M)]
- Respiratory Syncytial Virus A+B [Matrix protein gene (M)]
- Rhinovirus# [5'-UTR region]
#Both Rhinovirus and Enterovirus are detected but not differentiated.
C Type of Test:
Multiplexed real-time polymerase chain reaction (RT-PCR) nucleic acid assay for use with the QIAstat-Dx System for the qualitative detection of viral and bacterial pathogens in individuals with signs and symptoms of respiratory tract infection.
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## III Intended Use/Indications for Use:
### A Intended Use(s):
**The 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.
**The 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 (SARS-CoV-2).
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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 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 Mini. 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.
## B Indication(s) for Use:
See Intended Use(s).
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
For in vitro Diagnostic Use Only
## D Special Instrument Requirements:
The QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Respiratory Panel Mini are part of the QIAstat-Dx system and work only with QIAstat-Dx Analyzer 1.0, QIAstat-Dx Analyzer 2.0, or QIAstat-Dx Rise.
## IV Device/System Characteristics:
### A Device Description:
**QIAstat-Dx Respiratory Panel Plus and QIAstat-Dx Respiratory Panel Mini**
The QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Respiratory Panel Mini are part of the QIAstat-Dx system and work with QIAstat-Dx Analyzer 1.0, QIAstat-Dx Analyzer 2.0, or QIAstat-Dx Rise. The QIAstat-Dx Respiratory Panel Plus Cartridge and the QIAstat-Dx Respiratory Panel Mini Cartridge are single-use cartridges that include all reagents needed for nucleic acid extraction, nucleic acid amplification, and detection of bacteria and viruses (or their
K250080 - Page 4 of 23
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subtypes), including SARS-CoV-2, that cause respiratory symptoms. Testing requires a small specimen volume and minimal hands-on time, and the results are available in approximately one hour. The QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Respiratory Panel Mini are intended to be used with one (1) nasopharyngeal swab (NPS) eluted in Universal Transport Media (UTM), which is not provided with the QIAstat-Dx Respiratory Panel Plus or the QIAstat-Dx Respiratory Panel Mini.
The QIAstat-Dx Rise is a higher throughput platform than QIAstat-Dx Analyzer 1.0 or 2.0, incorporating up to eight QIAstat-Dx Analytical Modules (AM). 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 is used with the QIAstat-Dx Analyzer 1.0 or 2.0.
## B Principle of Operation:
Diagnostic tests with the QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Respiratory Panel Mini are performed on the QIAstat-Dx Analyzer 1.0, QIAstat-Dx Analyzer 2.0, or QIAstat-Dx Rise. All of the sample preparation and analysis steps are performed automatically by the QIAstat-Dx Analyzer 1.0, QIAstat-Dx Analyzer 2.0, or QIAstat-Dx Rise. Samples are collected and loaded manually, with a transfer pipette provided with the test kit, into the QIAstat-Dx Respiratory Panel Plus or QIAstat-Dx Respiratory Panel Mini Cartridge.
All the reagents required for the complete execution of the test are pre-loaded and self-contained in the QIAstat-Dx Respiratory Panel Plus Cartridge or 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 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 (TC).
- Drying of membrane with bound nucleic acids with 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 and TC).
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- Sequential transfer of defined aliquots of mixed eluate/Master Mix from the Transfer Chamber to each of eight Reaction Chambers containing the specified, air dried primers and probes. Note that each target specific probe contains a specific fluorescent dye that permits differentiation of target specific amplification within each Reaction Chamber.
- 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 Analyzer 1.0, QIAstat-Dx Analyzer 2.0, or QIAstat-Dx Rise automatically interprets test results and displays a summary on the 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").
## C Instrument Description Information:
1. Instrument Name:
QIAstat-Dx Analyzer 1.0 with software version 1.4 or 1.5
QIAstat-Dx Analyzer 2.0 with software version 1.6 or higher
QIAstat-Dx Rise with software version 2.4 or higher
2. Specimen Identification:
Each instrument is a fully automated instrument that is bi-directionally interfaced and accepts orders from the LIS system. While test orders can be manually programmed through the attached instrument computer, an LIS-generated barcode can also be scanned to initiate testing.
3. Specimen Sampling and Handling:
Nasopharyngeal swab (NPS) specimens collected in transport medium.
4. Calibration:
Each instrument is provided factory-calibrated and does not require user calibration.
5. Quality Control:
Please refer to the Quality Control information previously reviewed and presented in the K233100 FDA Decision Summary.
## V Substantial Equivalence Information:
### A Predicate Device Name(s):
QIAstat-Dx Respiratory Panel Plus, QIAstat-Dx Respiratory Panel Mini
### B Predicate 510(k) Number(s):
K233100 (QIAstat-Dx Respiratory Panel Plus), K242353 (QIAstat-Dx Respiratory Panel Mini)
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# C Comparison with Predicate(s):
Table 1. QIAstat-Dx Respiratory Panel Plus Substantial Equivalence Comparison.
| Device & Predicate Device(s): | K250080 (Subject) | K233100 (Predicate) |
| --- | --- | --- |
| Device Trade Name | QIAstat-Dx Respiratory Panel Plus | QIAstat-Dx Respiratory Panel Plus |
| Regulation | 21 CFR 866.3981 | 21 CFR 866.3981 |
| Product Code | QOF | QOF |
| Device Class | Class II | Class II |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | 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), Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), Bordetella | 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 A H3, 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 |
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K250080 - Page 8 of 23
| Device & Predicate Device(s): | K250080 (Subject) | K233100 (Predicate) |
| --- | --- | --- |
| | 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. | 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. |
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K250080 - Page 9 of 23
| Device & Predicate Device(s): | K250080 (Subject) | K233100 (Predicate) |
| --- | --- | --- |
| Specimen Type | Same | Nasopharyngeal swabs (NPS) |
| Assay Targets | Same | Twenty-one (21) targets |
| Amplification and Detection Technology | Same | PCR |
| Assay Controls | Same | One internal control in each cartridge to control for sample processing that is subjected to all nucleic acid extraction and amplification steps similar to patient samples. Instructions for Use indicates quality control requirements should be performed in conformance with local, state, and/or federal regulations or accreditation requirements and the laboratory’s standard quality control procedures. |
| Nucleic Acid Extraction | Same | Extraction of nucleic acids using spin columns |
| Technology | Same | Detection of amplified targets uses an increase in fluorescence to generate the assay results. |
| Operational | Same | The sample is loaded straight into the cartridge. |
| General Device Characteristic Differences | | |
| Amplification and Detection Instrument System | QIAstat-Dx Analyzer 1.0, QIAstat-Dx Analyzer 2.0, and QIAstat-Dx Rise | QIAstat-Dx Analyzer 1.0 and QIAstat-Dx Analyzer 2.0 |
| Cartridge loading into the QIAstat-Dx Analytical Module | QIAstat-Dx Analyzers – manual QIAstat-Dx Rise – automated | QIAstat-Dx Analyzers – manual |
| In-use Stability from opening cartridge package to loading cartridge into the QIAstat-Dx Instrument | QIAstat-Dx Analyzers – 120 minutes QIAstat-Dx Rise – 30 minutes | QIAstat-Dx Analyzers – 120 minutes |
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Table 2. QIAstat-Dx Respiratory Panel Mini Substantial Equivalence Comparison.
| Device & Predicate Device(s): | K250080 (Subject) | K242353 (Predicate) |
| --- | --- | --- |
| Device Trade Name | QIAstat-Dx Respiratory Panel Mini | QIAstat-Dx Respiratory Panel Mini |
| Regulation | 21 CFR 866.3981 | 21 CFR 866.3981 |
| Product Code | QOF | QOF |
| Device Class | Class II | Class II |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | 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 (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 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 | 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 |
K250080 - Page 10 of 23
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K250080 - Page 11 of 23
| Device & Predicate Device(s): | K250080 (Subject) | K242353 (Predicate) |
| --- | --- | --- |
| | 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 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. | 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. |
| Specimen Type | Same | Nasopharyngeal swabs (NPS) |
| Assay Targets | Same | Five (5) targets |
| Amplification and Detection Technology | Same | PCR |
| Assay Controls | Same | One internal control in each cartridge to control for sample processing that is subjected to all nucleic acid extraction and amplification steps similar to patient samples. Instructions for Use indicates quality control requirements should be performed in conformance with local, state, and/or federal regulations or accreditation requirements and the laboratory’s standard quality |
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| Device & Predicate Device(s): | K250080 (Subject) | K242353 (Predicate) |
| --- | --- | --- |
| | | control procedures. |
| Nucleic Acid Extraction | Same | Extraction of nucleic acids using spin columns |
| Technology | Same | Detection of amplified targets uses an increase in fluorescence to generate the assay results. |
| Operational | Same | The sample is loaded straight into the cartridge. |
| General Device Characteristic Differences | | |
| Amplification and Detection Instrument System | QIAstat-Dx Analyzer 1.0, QIAstat-Dx Analyzer 2.0, and QIAstat-Dx Rise | QIAstat-Dx Analyzer 1.0 and QIAstat-Dx Analyzer 2.0 |
| Cartridge loading into the QIAstat-Dx Analytical Module | QIAstat-Dx Analyzers – manual
QIAstat-Dx Rise – automated | QIAstat-Dx Analyzers – manual |
| In-use Stability from opening cartridge package to loading cartridge into the QIAstat-Dx Instrument | QIAstat-Dx Analyzers – 120 minutes
QIAstat-Dx Rise – 30 minutes | QIAstat-Dx Analyzers – 120 minutes |
VI Standards/Guidance Documents Referenced:
Standards
- ISO 14971 Third Edition 2019-12; Medical devices - Application of risk management to medical devices
- IEC 62304 Edition 1.1 2015-06; Medical device software - Software life cycle processes
- IEC 81001-5-1 Edition 1.0 2021-12; IEC 81001-5-1 Edition 1.0 2021-12; Health software and health IT systems safety effectiveness and security - Part 5-1: Security - Activities in the product life cycle
- IEC 61010-1 Edition 3.1 2017-01; Safety requirements for electrical equipment for measurement control and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)]
- IEC 60601-1-2 Edition 4.1 2020-09; Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 62366-1 Edition 1.1 2020-06; Medical devices - Part 1: Application of usability engineering to medical devices
K250080 - Page 12 of 23
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Special Controls
Class II Special Controls as per 21 CFR 866.3981
FDA Guidance Documents
- Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices (August 2014)
Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays (October 2009)
- Content of Premarket Submissions for Device Software Functions (June 2023)
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
A reproducibility study of the QIAstat-Dx Respiratory Panel Plus and the automated loading in the QIAstat-Dx Rise system was conducted by operators at three sites using panels of representative combined analytes at moderate positive, low positive, and negative concentrations. Samples were prepared by spiking individual pathogens in simulated NPS matrix (Table 3). The testing was performed across five non-consecutive days using three operators, three instruments (one per site), and three reagent lots. Each operator performed two replicates per analyte at each sample concentration each testing day for a total of 90 datapoints per analyte and concentration (3 operators x 2 replicates x 3 sites x 5 days). The results are shown in Table 4 and Table 5.
Table 3. Analyte Concentrations Used in the Reproducibility Study.
| Analyte (Strain/Isolate) | Catalog # | Low Positive Concentration (1x LoD) | Moderate Positive Concentration (3x LoD) | Units |
| --- | --- | --- | --- | --- |
| Influenza B (B/Taiwan/2/62) | ATCC VR-295 | 4.99E+01 | 1.50E+02 | TCID50/mL |
| Human coronavirus NL63 | ZeptoMetrix 0810228CFHI | 3.70E-02* | 1.11E-01** | TCID50/mL |
| Parainfluenza virus 3 (C-243) | ATCC VR-93 | 6.96E+00* | 2.09E+01** | TCID50/mL |
| Rhinovirus (HGP) | ATCC VR-482 | 8.88E+00 | 2.66E+01 | TCID50/mL |
| Adenovirus (G3) | ATCC VR-3 | 4.99E+03 | 1.5E+04 | TCID50/mL |
| Mycoplasma pneumoniae (PI 1428) | ATCC 29085 | 1.00E+00 | 3.00E+00 | CCU/mL |
| SARS-CoV-2 (England/02/2020) | 20/146 | 3.16E+02 | 9.48E+02 | Copies/mL |
* Human coronavirus NL63 and parainfluenza virus 3 was tested at or about 3x LoD.
** Human coronavirus NL63 and parainfluenza virus 3 was tested at 11x and 9x LoD, respectively.
K250080 - Page 13 of 23
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Table 4. Agreement with the Expected Results in the Reproducibility Study (Results Applicable for the QIAstat-Dx Respiratory Panel Mini Are Reported in Blue).
| Grouping Variable(s) | | | Agreement | | Two-Sided 95% Confidence Limit | |
| --- | --- | --- | --- | --- | --- | --- |
| Analyte | Sample Type | Site | Fraction | Percentage | Lower | Upper |
| Adenovirus | Low Positive | Site 1 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 3 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Total | 90 / 90 | 100.00% | 95.98% | 100.00% |
| | Moderate Positive | Site 1 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 3 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Total | 90 / 90 | 100.00% | 95.98% | 100.00% |
| Human coronavirus NL63 | Low Positive | Site 1 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 3 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Total | 90 / 90 | 100.00% | 95.98% | 100.00% |
| | Moderate Positive | Site 1 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 3 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Total | 90 / 90 | 100.00% | 95.98% | 100.00% |
| Influenza B | Low Positive | Site 1 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 3 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Total | 90 / 90 | 100.00% | 95.98% | 100.00% |
| | Moderate Positive | Site 1 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 3 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Total | 90 / 90 | 100.00% | 95.98% | 100.00% |
| Mycoplasma pneumoniae | Low Positive | Site 1 | 29 / 30 | 96.67% | 82.78% | 99.92% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 3 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Total | 89 / 90 | 98.89% | 93.96% | 99.97% |
| | Moderate Positive | Site 1 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 3 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Total | 90 / 90 | 100.00% | 95.98% | 100.00% |
| Parainfluenza virus 3 | Low Positive | Site 1 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 3 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Total | 90 / 90 | 100.00% | 95.98% | 100.00% |
| | Moderate Positive | Site 1 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 3 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Total | 90 / 90 | 100.00% | 95.98% | 100.00% |
| | Low Positive | Site 1 | 30 / 30 | 100.00% | 88.43% | 100.00% |
| | | Site 2 | 30 / 30 | 100.00% | 88.43% | 100.00% |
K250080 - Page 14 of 23
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Table 5. Precision Components in SD and CV% for Each Pathogen and Concentration, with 95% Confidence Intervals (Results Applicable for the QIAstat-Dx Respiratory Panel Mini Are Reported in Blue).
| Pathogen | Sample Type | # of Amplified | # of Non-Amplified | Mean Ct | Between Site SD % CV | Between Operator Within Site SD % CV | Between Day Within Site SD % CV | Between Lot SD % CV | Residual* SD % CV | #Total** SD % CV |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Adenovirus | Low | 89 | 0 | 34.29 | 0.05 | 0.00 | 0.00 | 0.02 | 0.71 | 0.71 |
| | | | | | 0.16% | 0.00% | 0.00% | 0.07% | 2.06% | 2.07% |
| Human coronavirus NL63 | 3.7xLoD | 90 | 0 | 34.06 | 0.12 | 0.00 | 0.09 | 0.15 | 0.44 | 0.48 |
| | | | | | 0.36% | 0.00% | 0.26% | 0.45% | 1.30% | 1.41% |
| Influenza B | 1xLoD | 90 | 0 | 33.98 | 0.22 | 0.00 | 0.00 | 0.00 | 0.74 | 0.76 |
| | | | | | 0.64% | 0.00% | 0.00% | 0.00% | 2.18% | 2.24% |
| Mycoplasma pneumoniae | 1xLoD | 89 | 1 | 33.72 | 0.08 | 0.00 | 0.00 | 0.00 | 0.73 | 0.73 |
| | | | | | 0.25% | 0.00% | 0.00% | 0.00% | 2.16% | 2.17% |
| Parainfluenza virus 3 | 3xLoD | 90 | 0 | 33.35 | 0.17 | 0.05 | 0.00 | 0.15 | 0.51 | 0.54 |
| | | | | | 0.50% | 0.16% | 0.00% | 0.44% | 1.53% | 1.63% |
| Human rhinovirus/Enterovirus*** | 1xLoD | 90 | 0 | 34.10 | 0.05 | 0.15 | 0.00 | 0.00 | 0.53 | 0.55 |
| | | | | | 0.14% | 0.43% | 0.00% | 0.00% | 1.54% | 1.60% |
| SARS-CoV-2 | 1xLoD | 88 | 2 | 35.33 | 0.00 | 0.19 | 0.00 | 0.00 | 0.50 | 0.53 |
| | | | | | 0.00% | 0.55% | 0.00% | 0.00% | 1.41% | 1.51% |
| Adenovirus | 3xLoD | 88 | 0 | 32.57 | 0.00 | 0.00 | 0.00 | 0.18 | 0.70 | 0.72 |
| | | | | | 0.00% | 0.00% | 0.00% | 0.55% | 2.15% | 2.20% |
| Human rhinovirus/Enterovirus* | 3xLoD | 88 | 0 | 32.57 | 0.00 | 0.00 | 0.00 | 0.18 | 0.70 | 0.72 |
| | | | | | 0.00% | 0.00% | 0.00% | 0.55% | 2.15% | 2.20% |
| SARS-CoV-2 | 3xLoD | 88 | 0 | 32.57 | 0.00 | 0.00 | 0.00 | 0.18 | 0.70 | 0.72 |
| | | | | | 0.00% | 0.00% | 0.00% | 0.55% | 2.15% | 2.20% |
*Reported as Human Rhinovirus in the QIAstat-Dx Respiratory Panel Mini.
K250080 - Page 15 of 23
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| Pathogen | Sample Type | # of Amplified | # of Non-Amplified | Mean Ct | Between Site SD % CV | Between Operator Within Site SD % CV | Between Day Within Site SD % CV | Between Lot SD % CV | Residual* SD % CV | #Total** SD % CV |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Human coronavirus NL63 | 11.1xLoD | 90 | 0 | 32.49 | 0.00
0.00% | 0.00
0.00% | 0.00
0.00% | 0.04
0.13% | 0.34
1.04% | 0.34
1.04% |
| Influenza B | 3xLoD | 90 | 0 | 32.20 | 0.00
0.00% | 0.15
0.47% | 0.00
0.00% | 0.10
0.32% | 0.56
1.74% | 0.58
1.82% |
| Mycoplasma pneumoniae | 3xLoD | 90 | 0 | 32.02 | 0.00
0.00% | 0.00
0.00% | 0.00
0.00% | 0.06
0.19% | 0.52
1.63% | 0.52
1.64% |
| Parainfluenza virus 3 | 9xLoD | 88 | 0 | 31.64 | 0.00
0.00% | 0.00
0.00% | 0.00
0.00% | 0.21
0.68% | 0.50
1.57% | 0.53
1.67% |
| Human rhinovirus/Enterovirus*** | 3xLoD | 89 | 0 | 32.78 | 0.12
0.37% | 0.02
0.05% | 0.13
0.39% | 0.13
0.39% | 0.46
1.40% | 0.50
1.52% |
| SARS-CoV-2 | 3xLoD | 89 | 0 | 34.16 | 0.00
0.00% | 0.11
0.33% | 0.11
0.31% | 0.00
0.00% | 0.36
1.05% | 0.39
1.13% |
*RESIDUAL refers to the within-run variability
**TOTAL means total variability observed across the study
***Reported as Human Rhinovirus in the QIAstat-Dx Respiratory Panel Mini
All negative, moderate positive, and low positive samples for all analytes exhibited acceptable performance. There were no significant differences observed within run, between lots, between days, between operators, or between sites (Table 5). Overall, Ct variability was low, and the study demonstrates assay variability within an acceptable range.
For the QIAstat-Dx Respiratory Panel Mini, the raw data generated with this study were reanalyzed using the Assay Definition File (ADF) corresponding to the QIAstat-Dx Respiratory Panel Mini. The reanalysis of the results using the QIAstat-Dx Respiratory Panel Mini Assay Definition File showed equivalent results to all the results obtained for the targets detected by both panels. Therefore, this study demonstrates the performance of the QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Respiratory Panel Mini is reproducible for the conditions tested when used in combination with the QIAstat-Dx Rise system.
2. Linearity:
Not applicable. The QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Respiratory Panel Mini are qualitative assays.
3. Analytical Specificity/Interference:
No new Analytical Specificity/Interference data were reviewed in this 510(k). The only modification to the QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Respiratory Panel Mini in this 510(k) submission is the addition of the QIAstat-Dx Rise instrument. Refer to FDA Decision Summary K233100 for Analytical Specificity/Interference data FDA reviewed and accepted previously.
4. Assay Reportable Range:
Not applicable. The QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Respiratory Panel Mini are qualitative assays.
K250080 - Page 16 of 23
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5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
a. Controls
Refer to section IV. C. 5 above.
b. In-Use Sample Stability
In-use sample stability testing demonstrated that the QIAstat-Dx Respiratory Panel Plus cartridge performance is not impacted when removing the cartridge from its primary container, and loading with an NPS sample after 30 minutes at room temperature (15 – 25°C), followed by a wait time up to 300 minutes at 30°C in the QIAstat-Dx Rise cartridge tray before running the cartridge.
The generated in-use sample stability raw data were reanalyzed with the QIAstat-Dx Respiratory Panel Mini ADF demonstrating the same in-use sample stability claim for the QIAstat-Dx Respiratory Panel Mini.
6. Detection Limit:
Please refer to the Detection Limit data previously reviewed and presented in the K233100 FDA Decision Summary.
7. Assay Cut-Off:
Assay Cut-Off for SARS-CoV-2 was established in K233100 and K183597 for the other analytes. No changes were made with the addition of the QIAstat-Dx Rise as an amplification and detection instrument system. The QIAstat-Dx Rise uses the same Assay Definition File (ADF) as the QIAstat-Dx Analyzers (1.0/2.0) to run the QIAstat-Dx Respiratory Panels.
8. Accuracy (Instrument):
Not Applicable.
9. Carry-Over:
A Carry-Over study was previously conducted under K233100 to examine cross-contamination between consecutive runs and between cartridge chambers. Please refer to the Carry-Over study data reviewed and presented in the K233100 FDA Decision Summary. An additional Carry-Over study was performed using the QIAstat-Dx Respiratory Panel Plus to evaluate the potential for cross-contamination during automatic handling of cartridges by the robotic arm and during cartridge storage in the sample input drawer.
A positive panel consisting of high concentrations of influenza B, parainfluenza virus 3, rhinovirus, M. pneumoniae, human coronavirus NL63, adenovirus, and SARS-CoV-2 were prepared in simulated NPS matrix. This positive panel was tested 22 times between runs of negative (no analyte) cartridges for a total of 8 runs and 18 cartridges/run (122 negative cartridges). No carryover between cartridges or chambers within the cartridges was observed.
The reanalysis of the results using the QIAstat-Dx Respiratory Panel Mini Assay Definition File showed equivalent results to all the results obtained for the targets detected by both panels.
K250080 - Page 17 of 23
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K250080 - Page 18 of 23
## B Comparison Studies:
1. **Method Comparison with Predicate Device:**
Not applicable.
2. **Matrix Comparison:**
Please refer to the Matrix Comparison data previously reviewed and presented in the K233100 FDA Decision Summary.
## C Clinical Studies:
1. **Clinical Sensitivity:**
Please refer to the Clinical Sensitivity data previously reviewed and presented in the K233100 FDA Decision Summary.
2. **Clinical Specificity:**
Please refer to the Clinical Specificity data previously reviewed and presented in the K233100 FDA Decision Summary.
3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):**
Not applicable.
## D Clinical Cut-Off:
Not applicable.
## E Expected Values/Reference Range:
Please refer to the Expected Values data previously reviewed and presented in the K233100 FDA Decision Summary.
## F Other Supportive Instrument Performance Characteristics Data:
### Instrument Equivalency Study
A study was performed to assess whether the performance of the QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Respiratory Panel Mini with the QIAstat-Dx Rise are equivalent to the performance with the QIAstat-Dx Analyzer 1.0 at low positive concentrations.
This study was initially performed for all targets included in the QIAstat-Dx Respiratory Panel Plus, except for SARS-CoV-2 (Table 6). Therefore, a second study was subsequently conducted that included SARS-CoV-2 and a representative panel of analytes included in the QIAstat-Dx Respiratory Panel Plus (Table 7). For each study, 20 replicates of co-spiked samples were tested at serial dilutions in the QIAstat-Dx Analyzer 1.0 until the lowest concentration where the target was detected ≥95% of the time was achieved. Then, the highest concentration where the target
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was detected $< 95\%$ of the time was also determined for each target. Then, the same concentrations were tested in the QIAstat-Dx Rise to evaluate the equivalency of both platforms. The results are summarized in Tables 6-8.
The reanalysis of the results using the QIAstat-Dx Respiratory Panel Mini Assay Definition File showed no discrepancies on the qualitative results (see Table 6 and Table 7). The only difference between the results of the QIAstat-Dx Respiratory Panel Plus and QIAstat-Dx Respiratory Panel Mini was the masking of the influenza A subtype (see Table 8).
Thes studies demonstrate equivalence of the QIAstat-Dx Respiratory Panel (Applicable Results to the QIAstat-Dx Respiratory Panel Mini performed on the QIAstat-Dx Rise when compared to the QIAstat-Dx Analyzer 1.0.
Table 6. Results for the Instrument Equivalency Study for the QIAstat-Dx Respiratory Panel (Applicable Results to the QIAstat-Dx Respiratory Panel Mini Highlighted in Blue, Except for Influenza A - See Table 8).
| Analyte | Concentration tested | QIAstat-Dx Analyzer 1.0 | | QIAstat-Dx Rise | |
| --- | --- | --- | --- | --- | --- |
| | | Hit rate | Ct mean | Hit rate | Ct mean |
| Influenza B (B/Florida/4/2006) (ATCC VR- 1804) | 1.08E+03 CEID50/mL | 20/20 | 32.7 | 20/20 | 32.3 |
| | 1.08E+02 CEID50/mL | 13/20 | 35.8 | 17/20 | 35.5 |
| Human coronavirus HKU1 (Clinical sample) | 4.00E+03 cop/mL | 19/20 | 37.1 | 19/20 | 37.3 |
| | 4.00E+02 cop/mL | 1/20 | 37.5 | 7/20 | 37.4 |
| Parainfluenza virus 3 (ATCC VR-93) | 2.32E+00 TCID50/mL | 20/20 | 35.8 | 20/20 | 35.0 |
| | 2.32E-01 TCID50/mL | 9/20 | 37.2 | 9/20 | 37.1 |
| Rhinovirus A2 (ATCC VR- 482) | 2.81E+01 TCID50/mL | 20/20 | 35.5 | 20/20 | 35.3 |
| | 8.88E+00 TCID50/mL | 18/20* | 36.8 | 20/20 | 36.3 |
| | 2.81E+00 TCID50/mL | 10/20 | 37.4 | 15/20 | 37.4 |
| Adenovirus B3 (ATCC VR-3) | 4.99E+03 TCID50/mL | 19/20 | 34.8 | 20/20 | 35.0 |
| | 4.99E+02 TCID50/mL | 7/20 | 37.2 | 2/20 | 37.4 |
| Mycoplasma pneumoniae (ATCC 29085) | 1.00E+00 ccu/mL | 20/20 | 34.0 | 20/20 | 33.7 |
| | 1.00E-01 ccu/mL | 11/20 | 36.2 | 12/20 | 36.1 |
| Influenza A H1N1 (New Caledonia/20/99) | 1.44E+01 TCID50/mL | 19/20 | 35.8 | 20/20 | 35. 5 |
| | 1.44E+01 TCID50/mL | 10/20 | 37.4 | 15/20 | 37.4 |
| Mumps virus 1 (ATCC VR-10) | 1.00E+01 TCID50/mL | 19/20 | 35.8 | 20/20 | 35.0 |
| | 1.00E+01 TCID50/mL | 10/20 | 37.4 | 15/20 | 37.4 |
| Mumps virus 2 (ATCC VR-10) | 1.00E+01 TCID50/mL | 19/20 | 35.8 | 20/20 | 35.0 |
| | 1.00E+01 TCID50/mL | 10/20 | 37.4 | 15/20 | 37.4 |
K250080 - Page 19 of 23
{19}
K250080 - Page 20 of 23
| Analyte
(ZeptoMetrix 0810036CFHI) | Concentration tested | QIAstat-Dx Analyzer 1.0 | | QIAstat-Dx Rise | |
| --- | --- | --- | --- | --- | --- |
| | | Hit rate | Ct mean | Hit rate | Ct mean |
| Human coronavirus OC43
(ZeptoMetrix 0810024CFHI) | 4.57E00 TCID_{50}/mL | 17/20 | 36.2 | 14/20 | 36.7 |
| | 3.32E+00 U/mL | 20/20 | 31.5 | 20/20 | 31.5 |
| | 3.32E-01 U/mL | 17/20 | 35.3 | 20/20 | 35.3 |
| | 1.05E-01 U/mL | 18/20* | 35.9 | 20/20 | 35.4 |
| Parainfluenza virus 1
(ATCC VR-94) | 1.58E+00 TCID_{50}/mL | 19/20 | 36.4 | 19/20 | 36.4 |
| | 1.58E-01 TCID_{50}/mL | 8/20 | 38.0 | 6/20 | 37.3 |
| RSV A (ATCC VR-1540) | 1.20E+02 PFU/mL | 20/20 | 36.8 | 20/20 | 36.3 |
| | 1.20E+01 PFU/mL | 6/20 | 36.9 | 6/20 | 37.4 |
| B. pertussis
(ATCC BAA- 2707) | 2.70E-01 cfu/mL | 20/20 | 35.2 | 19/20 | 35.5 |
| | 2.70E-02 cfu/mL | 8/20 | 36.8 | 7/20 | 36.7 |
| Influenza A H1N1
(pdm 09)
(A/Virginia/ATCC1/2009)
(ATCC VR-1736) | 2.12E+01 PFU/mL | 20/20 | 34.5 | 20/20 | 32.8 |
| | 6.70E+00 PFU/mL | 18/20* | 35.0 | 19/20 | 35.0 |
| | 6.70E-01 PFU/mL | 10/20 | 37.3 | 6/20 | 36.3 |
| Human coronavirus 229E
(ATCC VR-740) | 4.99E-01 TCID_{50}/mL | 19/20 | 36.0 | 20/20 | 35.8 |
| | 1.58E-02 TCID_{50}/mL | 18/20 | 37.0 | 18/20 | 37.0 |
| Parainfluenza virus 4a
(ATCC VR-1378) | 5.06E-01 TCID_{50}/mL | 19/20 | 36.6 | 20/20 | 35.4 |
| | 5.06E-02 TCID_{50}/mL+HH28:K28 | 8/20 | 36.9 | 14/20 | 36.8 |
| Enterovirus D68
(ATCC VR-1824) | 2.81E+01 TCID_{50}/mL | 19/20 | 37.3 | 19/20 | 37.1 |
| | 2.81E+00 TCID_{50}/mL | 3/20 | 37.0 | 5/20 | 37.1 |
| Human metapneumovirus A1
(ZeptoMetrix 0810024CFHI) | 1.51E+00 U/mL | 20/20 | 35.3 | 19/20 | 34.5 |
| | 1.51E-01 U/mL | 18/20 | 36.5 | 16/20 | 36.6 |
{20}
Table 7. Results for the Instrument Equivalency Study for the QIAstat-Dx Respiratory Panel Plus (Applicable Results to the QIAstat- Dx Respiratory Panel Mini Highlighted in Blue).
| Analyte | Concentration tested | QIAstat-Dx Analyzer 1.0 | | QIAstat-Dx Rise | |
| --- | --- | --- | --- | --- | --- |
| | | Hit rate | Ct mean | Hit rate | Ct mean |
| Influenza B (B/Taiwan/2/62) (ATCC, VR- 295) | 4.99E+01 TCID50/mL | 19/20 | 35.4 | 20/20 | 35.5 |
| | 4.99E+00 TCID50/mL | 6/20 | 37.1 | 4/20 | 37.6 |
| Human coronavirus NL63 (ZeptoMetrix, 0810228CFHI) | 3.70E-02 TCID50/mL | 20/20 | 34.6 | 20/20 | 35.0 |
| | 3.70E-03 TCID50/mL | 13/20 | 37.8 | 13/20 | 37.5 |
| Parainfluenza virus 3 (ATCC, VR- 93) | 6.96E+00 TCID50/mL | 20/20 | 34.1 | 20/20 | 34.8 |
| | 6.96E+00 TCID50/mL | 13/20 | 36.1 | 13/20 | 36.2 |
*For Influenza A H1N1 pdm09, influenza A H3N2, rhinovirus A and human coronavirus OC43 additional concentrations were tested. Statistical analysis confirmed there is no significant difference between either platform on the tested concentrations. Based on the obtained results, the platforms can be considered equivalent.
** Parainfluenza virus 1 did not initially show equivalency at $1.58\mathrm{E} + 00\mathrm{TCID}_{50} / \mathrm{mL}$ between the QIAstat-Dx Analyzer and the QIAstat-Dx Rise. However, testing was repeated with two additional sets of 20 replicates per instrument and equivalency between instruments was demonstrated in those sets.
K250080 - Page 21 of 23
{21}
Table 8. Results for the Instrument Equivalency Study and Comparison Between QIAstat-Dx Respiratory Panel Assays and Reanalysis Results for Influenza A Strains.
| Analyte | Concentration tested | Results QIAstat Dx-Respiratory Panel Plus* | | | Results QIAstat Dx-Respiratory Panel Mini | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Analyzer 1.0 | | Rise | Analyzer 1.0 | | Rise |
| Influenza A H1N1 (New Caledonia/20/99) (ZeptoMetrix 0810036CFHI) | 1.44E+01 TCID50/mL | Flu A: 20/20 H1: 19/20 | Flu A: 36.4 H1: 35.8 | Flu A: 20/20 H1: 20/20 | Flu A: 35.8 H1: 35.4 | Flu A: 20/20 | 36.4 |
| | 4.57E+00 TCID50/mL | Flu A: 20/20 H1: 19/20 | Flu A: 36.7 H1: 36.2 | Flu A: 16/20 H1: 14/20 | Flu A: 36.7 H1: 36.7 | Flu A: 20/20 | 36.7 |
| | | Flu A: 20/20 H1: 17/20 | Flu A: 36.2 H1: 36.7 | Flu A: 16/20 H1: 14/20 | Flu A: 36.7 H1: 36.7 | Flu A: 20/20 | 36.7 |
| H1N1 (New Caledonia/20/99) (ZeptoMetrix 0810036CFHI) | 1.44E+01 TCID50/mL | Flu A: 20/20 H1: 19/20 | Flu A: 36.4 H1: 35.8 | Flu A: 20/20 H1: 20/20 | Flu A: 35.8 H1: 35.4 | Flu A: 20/20 | 36.4 |
| | 4.57E+00 TCID50/mL | Flu A: 20/20 H1: 19/20 | Flu A: 36.7 H1: 36.2 | Flu A: 16/20 H1: 14/20 | Flu A: 36.7 H1: 36.7 | Flu A: 20/20 | 36.7 |
*For Parainfluenza virus 3 a new sample with a concentration 3x the LoD obtained for the QIAstat-Dx Analyzer (6.96E+00 TCID $_{50}$ /mL) was prepared and tested with both platforms, obtaining a hit rate of 100%. Statistical analysis confirmed there is no significant difference between either platform on the tested concentrations.
** For SARS-CoV-2 additional concentrations were tested. Statistical analysis confirmed there is no significant difference between either platform on the tested concentrations despite the minor difference in detection rate. Based on the obtained results, the platforms can be considered as equivalent.
K250080 - Page 22 of 23
{22}
| Analyte | Concentration | Results QIAstat Dx-Respiratory Panel Plus* | | | | Results QIAstat Dx-Respiratory Panel Mini | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Analyzer 1.0 | | Rise | | Analyzer 1.0 | | Rise | |
| | | Hit rate | Ct mean | Hit rate | Ct mean | Hit rate | Ct mean | Hit rate | Ct mean |
| | 4.57E-01 TCID50/mL | Flu A:7/20 H1: 2/20 | Flu A: 37.7 H1: 36.6 | Flu A: 4/20 H1: 1/20 | Flu A: 37.2 H1: 35.1 | Flu A: 7/20 | 37.7 | Flu A: 4/20 | 37.2 |
| Influenza A H1N1 (A/Virginia/ATC C1/2009) (ATCC VR-1736) | 2.12E+01 PFU/mL | Flu A: 20/20 H1N1: 20/20 | Flu A: 34.6 H1N1: 34.5 | Flu A: 20/20 H1N1: 20/20 | Flu A: 33.2 H1N1: 33.1 | Flu A: 20/20 | 34.6 | Flu A: 20/20 | 33.2 |
| | 6.70E+00 PFU/mL | Flu A: 20/20 H1N1 pdm: 18/20 | Flu A: 35.4 H1N1: 35.0 | Flu A: 20/20 H1N1 pdm: 19/20 | Flu A: 35.3 H1N1: 35.0 | Flu A: 20/20 | 35.4 | Flu A: 20/20 | 35.3 |
| | 6.70E-01 PFU/mL | Flu A: 14/20 H1N1 pdm: 10/20 | Flu A: 37.6 H1N1: 37.3 | Flu A: 11/20 H1N1 pdm: 6/20 | Flu A: 37.1 H1N1: 36.3 | Flu A: 14/20 | 37.6 | Flu A: 11/20 | 37.1 |
| Influenza A H3N2 (A/Port Chalmers/1/73) (ATCC VR-810) | 4.99E+03 CEID50/mL | Flu A: 20/20 H3: 20/20 | Flu A: 33.2 H3: 31.7 | Flu A: 20/20 H3: 20/20 | Flu A: 32.9 H3: 31.5 | Flu A: 20/20 | 33.2 | Flu A: 20/20 | 32.9 |
| | 1.58E +03 CEID50/mL | Flu A: 20/20 H3: 18/20 | Flu A: 36.2 H3: 34.6 | Flu A: 20/20 H3: 20/20 | Flu A: 35.7 H3: 34.2 | Flu A: 20/20 | 36.2 | Flu A: 20/20 | 35.7 |
| | 4.99E+02 CEID50/mL | Flu A: 17/20 H3: 17/20 | Flu A: 36.9 H3: 36.1 | Flu A: 17/20 H3: 16/20 | Flu A: 36.9 H3: 36.0 | Flu A: 17/20 | 36.9 | Flu A: 17/20 | 36.9 |
* Influenza A results were internally collected by reanalyzing the raw data with IN2DATA tool. This target is not reported by QIAstat-Dx Respiratory Panel ADF.
## VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
## IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K250080 - Page 23 of 23
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