Who is the manufacturer of QIAstat-Dx Respiratory Panel?

QIAGEN GmbH filed the 510(k) submission for QIAstat-Dx Respiratory Panel (K183597).

What is the FDA product code for QIAstat-Dx Respiratory Panel?

OCC. It is classified under 21 CFR 866.3980 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for QIAstat-Dx Respiratory Panel?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like QIAstat-Dx Respiratory Panel?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

QIAstat-Dx Respiratory Panel

Q: What are the predicate devices for QIAstat-Dx Respiratory Panel?

FilmArray Respiratory Panel (RP) (K123620).

K183597 · QIAGEN GmbH · OCC · May 18, 2019 · Microbiology

Device Facts

Record ID	K183597
Device Name	QIAstat-Dx Respiratory Panel
Applicant	QIAGEN GmbH
Product Code	OCC · Microbiology
Decision Date	May 18, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3980
Device Class	Class 2

Intended Use

The QIAstat-Dx Respiratory Panel is a multiplexed nucleic acid test intended for use with QIAstat-Dx system for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) eluted in Universal Transport Media (UTM) obtained from individuals suspected of respiratory tract infections. The following organism types and subtypes are identified using the QIAstat-Dx Respiratory Panel: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The detection and identification of 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 and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by the test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the QIAstat-Dx Respiratory Panel may not be the definite cause of disease. 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

Device is a multiplexed nucleic acid test for respiratory pathogens; uses single-test disposable cartridges containing pre-packaged reagents (wet/dry chemistry). Input: nasopharyngeal swab (NPS) in Universal Transport Media (UTM). Operation: user inserts cartridge into QIAstat-Dx Analyzer 1.0; system performs automated sample preparation (mechanical/chemical lysis, silica membrane purification) and multiplex rtPCR. Output: qualitative detection/identification of 21 viral/bacterial targets displayed on analyzer screen. Used in clinical laboratories by trained personnel. Results aid diagnosis alongside clinical/epidemiological data; not for sole diagnostic use. Benefits: rapid, automated, closed-system testing reducing user exposure to chemicals and potential contamination.

Clinical Evidence

Multi-center clinical study (5 US, 1 international) tested 2,304 residual NPS specimens (1,994 prospective, 310 archived). Compared QIAstat-Dx Respiratory Panel against FDA-cleared multiplexed respiratory pathogen panel. Overall PPA/NPA for most analytes exceeded 90%. Adenovirus PPA 95.6%, NPA 99.2%; Influenza A PPA 99.2%, NPA 99.5%; RSV PPA 96.3%, NPA 99.7%.

Technological Characteristics

Disposable plastic cartridge; pneumatic microfluidics; silica membrane-based nucleic acid extraction; rtPCR amplification; fluorescence detection. Reagents pre-loaded (liquid, air-dried, lyophilized). Analyzer 1.0 hosts cartridge, performs automated protocols. Internal control (MS2 phage) included in each cartridge. No user calibration required.

Indications for Use

Indicated for individuals suspected of respiratory tract infections presenting with signs and symptoms of respiratory infection. Used for qualitative detection/identification of viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) eluted in Universal Transport Media (UTM).

Regulatory Classification

Identification

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B; (2) Influenza A subtype H1 and Influenza A subtype H3; (3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B; (4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus; (5) Human Metapneumovirus; (6) Rhinovirus; and (7) Adenovirus.

Special Controls

*Classification.* Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;” (2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and (3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.

Predicate Devices

FilmArray Respiratory Panel (RP) (K123620)

Related Devices

K233100 — QIAstat-Dx® Respiratory Panel Plus · QIAGEN GmbH · May 10, 2024
K242353 — QIAstat-Dx Respiratory Panel Mini · QIAGEN GmbH · Oct 25, 2024
K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini · QIAGEN GmbH · Aug 27, 2025
K143080 — FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System · Biofire Diagnostics, LLC · Feb 17, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". QIAGEN GmbH Melissa Mahall Sr. Director Regulatory Affairs 19300 Germantown Road Germantown, Maryland 20874 May 18, 2019 Re: K183597 Trade/Device Name: QIAstat-Dx Respiratory Panel Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OCC, OEM, OOU, OEP, OOI, OTG, OZX, OZY, OQW, OZZ Dated: April 9, 2019 Received: April 9, 2019 Dear Melissa Mahall: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Uwe Scherf, Ph.D. Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183597 Device Name QIAstat-Dx Respiratory Panel #### Indications for Use (Describe) The QIAstat-Dx Respiratory Panel is a multiplexed nucleic acid test intended for use with QIAstat-Dx system for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) eluted in Universal Transport Media (UTM) obtained from individuals suspected of respiratory tract infections. The following organism types are identified using the QIAstat-Dx Respiratory Panel: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H1N1/pdm09, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae and Mycoplasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by the test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the QIAstat-Dx Respiratory Panel may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence and radiography) may be necessary when evaluating a patient with possible respiratory tract infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis and Parainfluenza Virus 1 were established primarily with retrospective clinical specimens. Performance characteristics for Chlamydophila pneumoniae, Parainfluenza Virus 2, Parainfluenza Virus 4, Influenza A subtype H1 and Coronavirus 229E were established primarily using contrived clinical specimens. Due to the genetic similarity between Human Rhinovirus and Enterovirus, the QIAstat-Dx Respiratory Panel cannot reliably differentiate them. A positive QI Respiratory Panel Rhinovirus/Enterovirus result should be followed-up using an alternate method (e.g., cell culture or sequence analysis). Performance characteristics for Influenza A were established when Influenza A H1N1-2009 and A H3 were the predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A strains are circulating or a novel Influenza A virus emerges. 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. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Page 1 of 43 ### 510(k) SUMMARY ## General Information | Submitted by: | QIAGEN GmbH QIAGEN Strasse 1 Hilden, Germany D-40724 | |-----------------|-------------------------------------------------------------------------------------------------------| | Contact Person: | Melissa Mahall Senior Director Regulatory Affairs 19300 Germantown Road Germantown, MD 20874 | | | Phone: 301-944-7768 Email: melissa.mahall@qiagen.com | | Date Prepared: | April 9, 2019 | | Device Name: | QIAstat-Dx® Respiratory Panel | | Trade Name: | QIAstat-Dx® Respiratory Panel | | Common Name: | QIAstat-Dx® Respiratory Panel | | Classification: | 866.3980 - Respiratory viral panel multiplex nucleic acid assay | | Product Code: | OCC, OEM, OOU, OEP, OTG, OQW, OOI, OZZ, OZY, OZX | # Predicate Device | Manufacturer | Product Name | 510(k) No. | |---------------------------|-----------------------------------|------------| | BioFire Diagnostics, Inc. | FilmArray® Respiratory Panel (RP) | K123620 | {5}------------------------------------------------ ### Device Description QIAstat-Dx® is based on single-test cartridges with pre-packaged reagents including both wet and dry chemistry to handle the sample preparation and detection steps for the presence of a range of selected analytes by PCR technology. After insertion of the sample, the QIAstat-Dx assay cartridge is processed by the QIAstat-Dx® Analyzer 1.0. ### Principle of Operation The QIAstat-Dx® Respiratory Panel is part of the QIAstat-Dx® system and works with the QIAstat-Dx® Analyzer 1.0. The OIAstat-Dx® Respiratory Panel is intended to be used with liquid sample nasopharyngeal swabs (NPS). Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 74 minutes. When the test is finished, the cartridge is removed by the user and discarded. The QIAstat-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"). ### Resuspension of IC and Prot K Following insertion of the cartridge, the IC and Prot K are resuspended with the buffer located in Reservoir 1 (resuspension buffer from R1 is added to the interconnected IC cavity and Prot K cavity and transferred repeatedly between the Transfer Chamber and the cavities to ensure resuspension. The resuspended IC and Prot K are transferred to the sample cavity. ### Cell Lysis Primary lysis of the cells and analytes present in a NPS sample and IC occurs by a combination of chemical and mechanical processes using a rotor inside the lysis chamber in the presence of a buffer that acts as a chemical agent in aiding the mechanical process. The fast movement of the rotor results in sample agitation, which creates turbulence and shear forces that favor the lysis of the cell wall. After mechanical lysis is completed, the primary lysate is transferred to the purification chamber through a frit with 80 um pore size. The second lysis buffer (from Reservoir 2) is added to the primary lysate to complete chemical lysis. {6}------------------------------------------------ #### Purification Binding reagent (from Reservoir 4) is added to the lysate in the purification cavity, and the mix is passed through the silica membrane. In this process, the DNA/RNA molecules stick to the membrane, and the remaining components of the lysate are delivered to the waste chamber. Then the membrane is washed with a first washing buffer (from Reservoir 5) to wash away proteins. This is followed by a second washing step with a second washing buffer (from Reservoir 6) to remove any remaining substances other than the nucleic acids. A subsequent drying step eliminates volatile substances from the silica membrane. Prior to the elution step, the Transfer Chamber is rinsed with the rinsing buffer (from Reservoir 7) in order to remove any potential inhibitors from previous processing steps. At the end of the process, the nucleic acids are released from the membrane using an elution buffer (from Reservoir 8). The eluate is collected in the Transfer Chamber. #### Rehydration of Master Mix A defined volume (approximately 135uL) of the eluate is delivered to the dry chemistry reservoir (DCC) to rehydrate the Master Mix. Any remaining eluate is transferred to the waste chamber. The eluate/Master Mix solution is mixed by repeated transfer between the Transfer Chamber and the DCC. #### Aliquotting and PCR Defined aliquots (approximately 15 uL) of mixed eluate/Master Mix are sequentially transferred from the Transfer Chamber to each of seven Reaction Chambers containing the specified, air dried primers and probes. Within each Reaction Chamber, multiplex rtPCR testing is performed. Increase in fluorescence (indicative of detection of each target analyte) is detected directly within each Reaction Chamber. The rtPCR process is conducted by two submodules of the QIAstat-Dx® Analyzer 1.0: the Thermal Cycler and the qPCR Sensor. #### Components Description QIAstat-Dx® Respiratory Panel Cartridge: The QIAstat-Dx® Respiratory Panel cartridge is a disposable plastic device that allows performing fully automated molecular assays. The main features of the QIAstat-Dx® Respiratory Panel cartridge for the RP assay include the ability to test liquid samples as well as direct swabs and the capacity to store all necessary reagents within the cartridge needed for such testing. The cartridge is also designed to allow future expansion to incorporate additional sample types, such as swabs. All sample preparation and assay steps will be performed within the cartridge. All the reagents required for the complete execution of the test are pre-loaded and selfcontained in the QIAstat-Dx® Respiratory Panel. The user does not need to manipulate {7}------------------------------------------------ any reagents. During the test, reagents are handled by pneumatically-operated microfluidics without any direct contact with the user or the analyzer actuators. This eliminates any possibility of exposure of the user or the analyzer to chemicals contained in the cartridge during the test and up to the disposal of used cartridges. Reagents may be found in three different physical forms: liquid, air-dried on surfaces or lyophilized powder cake. 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 to their intended destinations. ### QIAstat-Dx Analyzer 1.0 The QIAstat-Dx® Analyzer 1.0 is the unit that hosts a cartridge and, on command from the user, is able to run predefined assay protocols. The software specific to this test is preloaded on the QIAstat-Dx® Analyzer 1.0. ### Other Materials Each QIAstat-Dx® Respiratory Panel cartridge will be used with a transfer pipette. The NPS sample from the patient will be collected in a sample tube using a swab in transport medium (not provided with device). QIAstat-Dx® Analyzer - the QIAstat-Dx® Respiratory Panel cartridge can only be run on the QIAstat-Dx® Analyzer. ### Calibrators and/or Controls Blank controls are not applicable to the device because it is a single test disposable cartridge. Negative and positive external controls are recommended by the company but not provided with the QIAstat-Dx® Respiratory Panel. OIAGEN provides an Internal Control within the OIAstat-Dx® Respiratory Panel cartridge. The IC is an MS2 phage. The IC is located in the IC cavity and is mixed with the sample during sample preparation and the eluate is mixed with the Master Mix, then aliquoted in all Reaction Chambers. The primers and probes necessary to detect the IC are present in Reaction Chamber 1. The IC is a process control that will go through all nucleic acid extraction and amplification steps, similar to patient samples. The Analyzer 1.0 is provided factory calibrated and does not require user calibration. The Analyzer 1.0 includes self-check controls to verify the performance of all sensors and actuators and will alert the user in case of failure. The RCA will provide the results to the Application Software. The Application SW will store all the information related to a given result in the database and will display a summary of detected and equivocal analytes and the result for the IC. All POSITIVE or EQUIVOCAL analytes will be listed as "DETECTED PATHOGENS". The screen will {8}------------------------------------------------ also display the complete list of all "TESTED PATHOGENS", including positive, negative, equivocal or invalid analytes. #### Specimen collection and transport materials Samples are collected using a single-use Nasopharyngeal swab and a tube filled with transport medium. NPS swab specimens are to be collected and eluted using one of the following compatible collection kits: Universal Transport Medium (UTM™) (Copan Diagnostics (Brescia, Italy and CA, USA)), MicroTest™ M4, M4RT, M5, M6 (ThermoFisher Scientific, MA, USA), BD Universal Viral Transport (UVT) System (Becton Dickinson, NJ, USA), Universal Transport Medium (UTM) System (HealthLink Inc., FL, USA), Universal Transport Medium (Diagnostic Hybrids, OH, USA), V-C-M Medium (Quest Diagnostics, NJ, USA) or UniTranz-RT® Universal Transport Media (Puritan Diagnostics, ME , USA) collection kits. #### Accessories and requirements To be used in combination with the QIAstat-Dx Analyzer. Transfer pipette (MS-253003) used with each QIAstat-Dx® Respiratory Panel cartridge. #### Intended Use The QIAstat-Dx® Respiratory Panel is a multiplexed nucleic acid test intended for use with QIAstat-Dx® system for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) eluted in Universal Transport Media (UTM) obtained from individuals suspected of respiratory tract infections. The following organism types and subtypes are identified using the QIAstat-Dx Respiratory Panel: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A. Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The detection and identification of 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 and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by the test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the OIAstat-Dx Respiratory Panel may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and {9}------------------------------------------------ radiography) may be necessary when evaluating a patient with possible respiratory tract infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis and Parainfluenza Virus 1 were established primarily with retrospective clinical specimens. Performance characteristics for Chlamydophila pneumoniae, Parainfluenza Virus 2, Parainfluenza Virus 4, Influenza A subtype H1 and Coronavirus 229E were established primarily using contrived clinical specimens. Due to the genetic similarity between Human Rhinovirus and Enterovirus, the QIAstat-Dx Respiratory Panel cannot reliably differentiate them. A positive OIAstat-Dx Respiratory Panel Rhinovirus/Enterovirus result should be followed-up using an alternate method (e.g., cell culture or sequence analysis). Performance characteristics for Influenza A were established when Influenza A H1N1-2009 and A H3 were the predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A strains are circulating or a novel Influenza A virus emerges. 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. ### Comparison of the OIAstat-Dx® Respiratory Panel and the Predicate Device The QIAstat-Dx® Respiratory Panel is substantially equivalent to the predicate device: - K123620: FilmArray® Respiratory Panel Similarities and differences between the QIAstat-Dx® Respiratory Panel and the predicate device are shown in Table 5.1. | Characteristic | Device | Predicate | |---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | QIAstat-Dx® Respiratory Panel | BioFire Diagnostics, Inc.'s FilmArray® Respiratory Panel (RP) | | | | | | | | | | 510(k) No. | K183597 | K123620 | | Regulation | 21 CFR 866.3980 | 21 CFR 866.3980 | | Product Code | OCC | OCC | | Device Class | Class II | Class II | | Characteristic | Device | Predicate | | | Similarities | | | Intended Use | The QIAstat-Dx Respiratory Panel is a multiplexed nucleic acid test intended for use with QIAstat-Dx system for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) eluted in universal transport media (UTM) obtained from individuals suspected of respiratory tract infections. The following organism types and subtypes are identified using the QIAstat-Dx Respiratory Panel: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. | FilmArray® Respiratory Panel (RP) is a multiplexed nucleic acid test intended for use with the FilmArray Instrument for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The following organism types and subtypes are identified using the FilmArray RP: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Human Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. | | | The detection and identification of 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 and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. | Negative results in the setting of a | | Characteristic | Device | Predicate | | | Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by the test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the QIAstat-Dx Respiratory Panel may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection. | respiratory illness may be due to infection with pathogens that are not detected by this test or, lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out coinfection with other organisms: the agent(s) detected by the Film Array RP may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection. | | | Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis and Parainfluenza Virus 1 were established primarily with retrospective clinical specimens. | Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis, Coronavirus 229E, Coronavirus OC43, Influenza A H1, Influenza A H3, Influenza A H1-2009, Influenza B, Mycoplasma pneumoniae, Parainfluenza Virus 1, Parainfluenza Virus 2, and Parainfluenza Virus 4 were established primarily with retrospective clinical specimens. | | | Performance characteristics for Chlamydophila pneumoniae, Parainfluenza Virus 2, Parainfluenza Virus 4, Influenza A subtype H1 and Coronavirus 229E were established primarily using contrived clinical specimens. | Performance characteristics for Chlamydophila pneumoniae were established primarily using contrived clinical specimens. | | | Due to the genetic similarity between Human Rhinovirus and Enterovirus, the QIAstat-Dx Respiratory Panel cannot reliably differentiate them. A positive QIAstat-Dx Respiratory Panel Rhinovirus/Enterovirus result should be followed up using an | Due to the genetic similarity between Human Rhinovirus and Enterovirus, the FilmArray RP cannot reliably differentiate them. A positive FilmArray RP Rhinovirus/Enterovirus result should be followed-up using an alternate method (e.g., cell culture | | Characteristic | Device | Predicate | | | alternate method (e.g., cell culture or sequence analysis). Performance characteristics for Influenza A were established when Influenza A H1N1-2009 and A H3 were the predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A strains are circulating or a novel Influenza A virus emerges. 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. | or sequence analysis). The FilmArray RP assay for Coronavirus OC43 may cross- react with some isolates of Coronavirus HKU1. A dual positive result may be due to cross-reactivity or may indicate a co-infection. Performance characteristics for Influenza A were established when Influenza A H1-2009, A H1, and A H3 were the predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A strains are circulating or a novel Influenza A virus emerges. 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. | | Specimen Type | Nasopharyngeal swabs (NPS) eluted in UTM | Nasopharyngeal swabs (NPS) | | Assay Targets Amplification and Detection Technology | See analyte list above, RNA/ DNA PCR | See analyte list above, RNA/DNA PCR | | Assay Controls | One internal control in each cartridge to control for sample processing that is subjected to all nucleic acid extraction and | Two controls are included in each reagent pouch to control for sample processing and both stages of PCR and melt analysis. | | Characteristic | Device…