QIAstat-Dx Gastrointestinal Panel 2

K220062 · QIAGEN GmbH · PCH · May 31, 2024 · Microbiology

Device Facts

• Record ID: K220062
• Device Name: QIAstat-Dx Gastrointestinal Panel 2
• Applicant: QIAGEN GmbH
• Product Code: PCH · Microbiology
• Decision Date: May 31, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3990
• Device Class: Class 2

Indications for Use

The QIAstat-Dx Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 1.0. for the simultaneous in vitro qualitative detection of nucleic acids from multiple viruses, bacteria. and parasites directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following viruses, bacteria (including several diarrheagenic E. col/ Shigella pathotypes), and parasites are identified with the QIAstat-Dx Gastrointestinal Panel 2 : Concomitant culture is necessary for organism recovery and further typing of bacterial agents. The QIAstat-Dx Gastrointestinal Panel 2 is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out coinfection with organisms not detected by the QIAstat-Dx Gastrointestinal Panel 2. The organisms detected may not be the sole or definitive cause of the disease. Negative QIAstat-Dx Gastrointestinal Panel 2 results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

Device Story

Multiplexed nucleic acid test for stool samples (Para-Pak C&S or FecalSwab); uses single-use cartridge with pre-packaged reagents; processed by QIAstat-Dx Analyzer 1.0. Workflow: sample insertion; automated lysis (chemical/mechanical with silica beads); nucleic acid purification via silica membrane; rehydration of dry master mix; rtPCR amplification in eight reaction chambers; real-time fluorescence detection. Analyzer interprets results; displays detected pathogens on screen. Used in clinical labs; operated by technicians. Provides rapid identification of GI pathogens; aids diagnosis; supports clinical decision-making; helps differentiate infectious from non-infectious causes.

Clinical Evidence

Prospective multi-center study (13 sites, 1939 specimens) compared QIAstat-Dx GI Panel 2 against FDA-cleared comparators or composite reference methods. Performance metrics (PPA/NPA) calculated for each analyte. PPA generally >90% for most targets; NPA >99%. Study included prospective archived and retrospective samples to supplement low-prevalence targets. Bench testing confirmed LoD, inclusivity, specificity, and interference resistance.

Technological Characteristics

Disposable plastic cartridge; contains all reagents (liquid, air-dried, lyophilized). Uses pneumatic microfluidics for fluid transfer. Lysis: chemical/mechanical (rotor + silica beads). Purification: silica membrane. Amplification: rtPCR (reverse transcription + real-time PCR). Connectivity: standalone analyzer. Software: preloaded assay-specific protocols.

Indications for Use

Indicated for individuals with signs/symptoms of gastrointestinal infection. Detects nucleic acids from viruses (Adenovirus F40/F41, Astrovirus, Norovirus GI/GII, Rotavirus A), bacteria (Campylobacter, Shigella/EIEC, EPEC, ETEC, STEC, Salmonella, Plesiomonas shigelloides, Yersinia enterocolitica), and parasites (Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia) in preserved stool samples.

Regulatory Classification

Identification

A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

Special Controls

*Classification.* Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).

Predicate Devices

• FilmArray® Gastrointestinal (GI) Panel (K140407)

Submission Summary (Full Text)

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May 31, 2024

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

QIAGEN GmbH % Selina Salthouse Regulatory Affairs Manager QIAGEN Manchester Ltd CityLabs 2.0. 200 Hathersage Road Manchester, Manchester M13 0BH, United Kingdom

### Re: K220062

Trade/Device Name: QIAstat-Dx Gastrointestinal Panel 2 Regulation Number: 21 CFR 866.3990 Regulation Name: Gastrointestinal microorganism multiplex nucleic acid-based assay Regulatory Class: Class II Product Code: PCH Dated: April 4, 2023 Received: April 4, 2023

### Dear Selina Salthouse:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Noel J. Gerald -S

Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known) K220062

#### Device Name QIAstat-Dx Gastrointestinal Panel 2

#### Indications for Use (Describe)

The QIAstat-Dx Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 1.0. for the simultaneous in vitro qualitative detection of nucleic acids from multiple viruses, bacteria. and parasites directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following viruses, bacteria (including several diarrheagenic E. col/ Shigella pathotypes), and parasites are identified with the QIAstat-Dx Gastrointestinal Panel 2 :

| Pathogen | Para-Pak C&S | FecalSwab |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------|
| • Adenovirus F40/F41 | Reported | Reported |
| • Astrovirus | Reported | Reported |
| • Norovirus GI/GII | Reported | Reported |
| • Rotavirus A | Reported | Reported |
| • Campylobacter (C. jejuni, C. coli and C. upsaliensis) | Reported | Reported |
| • Shigella/Enteroinvasive Escherichia coli (EIEC) | Reported | Reported |
| • Enteropathogenic Escherichia coli (EPEC) | Reported | Not Reported |
| • Enterotoxigenic Escherichia coli (ETEC) lt/st | Reported | Reported |
| • Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2<br>(including specific identification of E. coli O157 serogroup within STEC) | Reported | Not Reported |
| • Salmonella | Reported | Reported |
| • Plesiomonas shigelloides | Reported | Reported |
| • Yersinia enterocolitica | Reported | Reported |
| • Cryptosporidium | Reported | Reported |
| • Cyclospora cayetanensis | Reported | Reported |
| • Entamoeba histolytica | Reported | Reported |
| • Giardia lamblia* | Reported | Reported |

*(Also known as Giardia intestinalis and Giardia duodenalis)

Concomitant culture is necessary for organism recovery and further typing of bacterial agents.

The QIAstat-Dx Gastrointestinal Panel 2 is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out coinfection with organisms not detected by the QIAstat-Dx Gastrointestinal Panel 2. The organisms detected may not be the sole or definitive cause of the disease.

Negative QIAstat-Dx Gastrointestinal Panel 2 results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 5.0 510(k) SUMMARY

### General Information

| Submitted by: | QIAGEN GmbH<br>Qiagen Strasse 1<br>Hilden, 40724,Germany |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Selina Salthouse<br>Manager, Regulatory Affairs<br>QIAGEN Manchester Ltd<br>Citylabs 2.0, 200 Hathersage Road<br>Manchester, M13 0BH, UK<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | May 30, 2024 |
| Device Name: | QIAstat-Dx® Gastrointestinal Panel 2 |
| Trade Name: | QIAstat-Dx® Gastrointestinal Panel 2 |
| Common Name: | QIAstat-Dx® Gastrointestinal Panel 2 |
| Classification: | 21 CFR 866.3990 - Gastrointestinal Pathogen Panel Multiplex<br>Nucleic Acid-Based Assay System |
| Product Code: | PCH |

### Predicate Device

| Manufacturer | Product Name | 510(k) No. |
|-------------------------|-------------------------------------------|------------|
| BioFire Diagnostics LLC | FilmArray®<br>Gastrointestinal (GI) Panel | K140407 |

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### 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 OIAstat-Dx assay cartridge is processed by the OIAstat-Dx Analyzer 1.0.

### Principle of Operation

The QIAstat-Dx Gastrointestinal Panel 2 is part of the QIAstat-Dx system and works with the QIAstat-Dx Analyzer 1.0.

The OIAstat-Dx Gastrointestinal Panel 2 is intended to be used with stool samples in Para-Pak C&S or FecalSwab transport media.

Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 78 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. For other analytes tested, they are displayed in green if not detected or in gray if not applicable or invalid. 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").

### Sample Pre-treatment for PCR Inhibitors removal

Following insertion of the cartridge, the buffer located in Reservoir 1 is added inside the lysis chamber and homogenized with the sample using a rotor in the presence of silica beads. This enables separation of commonly found inhibitory substances in stool from the DNA/RNA by chemical means.

### Resuspension of Internal Control (IC) and Proteinase K

Following sample pre-treatment, the IC and Proteinase K is resuspended with the buffer located in Reservoir 2 (resuspension buffer). The buffer from Reservoir 2 is added to the interconnected IC cavity and Proteinase K cavity and transferred repeatedly between the Transfer Chamber and the cavities to ensure resuspension. The resuspended IC and Proteinase K are transferred to the sample cavity.

### Cell Lysis

Primary lysis of the cells and analytes present in a stool sample and IC occurs by a combination of chemical and mechanical processes using a rotor inside the lysis chamber in the presence of silica beads and a buffer that acts as a chemical agent in aiding the mechanical process. The fast movement of the rotor in the presence of the silica beads results in sample agitation, which creates turbulence and shear forces that favor the lysis of the cell wall.

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After mechanical lysis is completed, the primary lysate is transferred to the purification chamber through a frit with 2-5 um pore size. The second lysis buffer (from Reservoir 3) is added to the primary lysate to complete chemical lysis.

### Purification

Binding reagent (from Reservoir 4) is added to the lysate in the purification chamber, 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 (135 µL) of the eluate is delivered to the reservoir of the Dry Chemistry Container (DCC) to rehydrate the Master Mix. Any remaining eluate is transferred to the Reservoir 7. The eluate/Master Mix solution is mixed by repeated transfer between the Transfer Chamber and the DCC.

### Aliquoting and PCR

Defined aliquots (15 µL) of mixed eluate/Master Mix are sequentially transferred from the Transfer Chamber to each of eight Reaction Chambers containing the specified, air dried primers and probes.

Within each Reaction Chamber, a reverse-transcription step followed by real time, multiplex PCR ("rtPCR") 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

OIAstat-Dx Gastrointestinal Panel 2 Cartridge:

The QIAstat-Dx Gastrointestinal Panel 2 cartridge is a disposable plastic device that allows performing fully automated molecular assays. The main features of the OIAstat-Dx Gastrointestinal Panel 2 cartridge for the Gastrointestinal assay include the ability to test liquid samples and the capacity to store all necessary reagents within the cartridge needed for such testing. All sample preparation and assay steps will be performed within the cartridge.

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All the reagents required for the complete execution of the test are pre-loaded and selfcontained in the OIAstat-Dx Gastrointestinal Panel 2. 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. 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 Gastrointestinal Panel 2 cartridge will be used with a transfer pipette (provided with device). The stool sample from the patient will be collected in Para-Pak C&S or FecalSwab transport medium following the manufacturer's instructions for use (not provided with device).

QIAstat-Dx Analyzer 1.0 - the QIAstat-Dx Gastrointestinal Panel 2 cartridge can only be run on the QIAstat-Dx Analyzer 1.0.

### 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 OIAstat-Dx Gastrointestinal Panel 2.

QIAGEN provides an IC within the QIAstat-Dx Gastrointestinal Panel 2 cartridge which provides a full process control covering lysis, nucleic acid purification, reverse transcription and DNA amplification. The IC is Schizosaccharomyces pombe. 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 results screen displays a message indicating that the Internal Control "Passed" when the test is run successfully. An IC message of "Failed" indicates that the internal control was not amplified; 'Positive' test results are then reported as POSITIVE* (positive with warning), all 'Negative' results are invalid.

The OIAstat-Dx Analyzer 1.0 is provided factory calibrated and does not require user calibration. The OIAstat-Dx 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.

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The RCA will provide the results to the Application Software (SW). The Application SW will store the information related to a given result in the database and will display a summary of detected analytes and the result for the IC. All POSITIVE analytes will be listed as "DETECTED PATHOGENS". The screen will also display the complete list of all "TESTED PATHOGENS", including positive, not applicable or invalid analytes. All results for tests executed on each QIAstat-Dx Analyzer 1.0 are stored and can be reviewed in a specific archive on each QIAstat-Dx Analyzer 1.0.

### Specimen collection and transport materials

Stool samples are collected and resuspended in Para-Pak C&S or FecalSwab transport medium following the manufacturer's instructions (Para-Pak C&S (Meridian Bioscience) or FecalSwab (COPAN)).

#### Intended Use

The QIAstat-Dx® Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the OIAstat-Dx Analyzer 1.0 for the simultaneous in vitro qualitative detection and identification of nucleic acids from multiple viruses, bacteria, and parasites directly from preserved stool samples (Para-Pak® C&S or FecalSwab™) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following viruses, bacteria (including several diarrheagenic E.coli/Shigella pathotypes), and parasites are identified with the QIAstat-Dx® Gastrointestinal Panel 2:

| Pathogen | Para-Pak C&S | FecalSwab |
|----------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------|
| Adenovirus F40/F41 | ✓ | ✓ |
| Astrovirus | ✓ | ✓ |
| Norovirus GI/GII | ✓ | ✓ |
| Rotavirus A | ✓ | ✓ |
| Campylobacter (C. jejuni, C. coli and C. upsaliensis) | ✓ | ✓ |
| Shigella/Enteroinvasive Escherichia coli (EIEC) | ✓ | ✓ |
| Enteropathogenic Escherichia coli (EPEC) | ✓ | Not reported |
| Enterotoxigenic Escherichia coli (ETEC) lt/st | ✓ | ✓ |
| Shiga-like toxin-producing Escherichia coli (STEC)<br>stx1/stx2 (including specific identification of E. coli<br>O157 serogroup within STEC) | ✓ | Not reported |
| Salmonella | ✓ | ✓ |
| Plesiomonas shigelloides | ✓ | ✓ |
| Yersinia enterocolitica | ✓ | ✓ |
| Cryptosporidium | ✓ | ✓ |
| Cyclospora cayetanensis | ✓ | ✓ |
| Entamoeba histolytica | ✓ | ✓ |
| Giardia lamblia* | ✓ | ✓ |

* Also known as Giardia intestinalis and Giardia duodenalis

Concomitant culture is necessary for organism recovery and further typing of bacterial agents.

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The QIAstat-Dx® Gastrointestinal Panel 2 is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out co-infection with organisms not detected by the QIAstat-Dx® Gastrointestinal Panel 2. The organisms detected may not be the sole or definitive cause of the disease.

Negative QIAstat-Dx® Gastrointestinal Panel 2 results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

### Comparison of the QIAstat-Dx® Gastrointestinal Panel 2 and the Predicate Device

The QIAstat-Dx Gastrointestinal Panel 2 is substantially equivalent to the predicate device:

- K140407: BioFire Diagnostics LLC FilmArray® Gastrointestinal (GI) Panel
Similarities and differences between the QIAstat-Dx Gastrointestinal Panel 2 and the predicate device are shown in Table 5.1.

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Table 5.1: Comparison of the QIAstat-Dx Gastrointestinal Panel 2 with the predicate device

| Characteristic | Device | Predicate | |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | QIAstat-Dx Gastrointestinal Panel 2 | BioFire Diagnostics, LLC.<br>FilmArray Gastrointestinal (GI) Panel | |
| 510(k) No. | K220062 | K140407 | |
| Regulation | 21 CFR 866.3990 | 21 CFR 866.3990 | |
| Product Code | PCH | PCH | |
| Device Class | Class II | Class II | |
| Similarities | | | |
| Intended Use | The QIAstat-Dx® Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 1.0 for the simultaneous qualitative detection and identification of nucleic acids from multiple viruses, bacteria, and parasites directly from preserved stool samples (Para-Pak® C&S or FecalSwabTM) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following viruses, bacteria (including several diarrheagenic E.coli/Shigella pathotypes), and parasites are identified with the QIAstat-Dx® Gastrointestinal Panel 2: Adenovirus F40/F41 Astrovirus Norovirus GI/GII Rotavirus A Campylobacter ( <i>C. jejuni, C. coli and C. upsaliensis</i> ) Shigella/Enteroinvasive Escherichia coli (EIEC) Enteropathogenic Escherichia coli (EPEC) (only with Para-Pak C&S, not reported for FecalSwab) Enterotoxigenic Escherichia coli (ETEC) lt/st | The FilmArray® Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based test intended for use with the FilmArray® Instrument for the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair medium, obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including several diarrheagenic <i>E. coli/Shigella</i> pathotypes), parasites, and viruses are identified using the FilmArray GI Panel: Campylobacter ( <i>C. jejuni/C. coli/C. upsaliensis</i> Clostridium difficile ( <i>C. difficile</i> ) toxin A/B Plesiomonas shigelloides Salmonella Vibrio (V> parahaemolyticus/V. vulnificus/ V. cholerae) including specific identification of Vibrio cholerae Yersinia enterocolitica | |
| Characteristic | Device | Predicate | |
| | Shiga-like toxin-producing<br><i>Escherichia coli</i> (STEC) stx1/stx2 (including specific identification of <i>E. coli</i> O157 serogroup within STEC) (only with Para-Pak C&S, not reported for FecalSwab) <i>Salmonella Plesiomonas shigelloides Yersinia enterocolitica Cryptosporidium Cyclospora cayetanensis Entamoeba histolytica Giardia lamblia</i> (Also known as <i>Giardia intestinalis</i> and <i>Giardia duodenalis</i> ) Concomitant culture is necessary for organism recovery and further typing of bacterial agents.<br>The QIAstat-Dx® Gastrointestinal Panel 2 is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out co-infection with organisms not detected by the QIAstat-Dx® Gastrointestinal Panel 2. The organisms detected may not be the sole or definitive cause of the disease.<br>Negative QIAstat-Dx® Gastrointestinal Panel 2 results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, | Enteroaggregative <i>Escherichia coli</i> (EAEC) Enteropathogenic <i>Escherichia coli</i> (EPEC) Enterotoxigenic <i>Escherichia coli</i> (ETEC) lt/st Shiga-like toxin-producing <i>Escherichia coli</i> (STEC) stx1/stx2 (including specific identification of the <i>E. coli</i> O157 serogroup within STEC) <i>Shigella/Enteroinvasive Escherichia coli</i> (EIEC) <i>Cryptosporidium Cyclospora cayetanensis Entamoeba histolytica Giardia lamblia</i> (also known as <i>G. intestinalis</i> and <i>G. duodenalis</i> ) Adenovirus F 40/41 Astrovirus Norovirus GI/GII Rotavirus A Sapovirus (Genogroups I, II, IV and V) The FilmArray® Gastrointestinal Panel is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the FilmArray® GI Panel. The agent detected may not be the definite cause of the disease. | |
| Characteristic | Device | Predicate | |
| | irritable bowel syndrome, or<br>Crohn's disease. | Concomitant culture is<br>necessary for organism<br>recovery and further typing of<br>bacterial agents. | |
| | | This device is not intended to<br>monitor or guide treatment for<br><i>C. difficile</i> infection. | |
| | | Due to the small number of<br>positive specimens collected<br>for certain organisms during<br>the prospective clinical study,<br>performance characteristics for<br><i>E. coli</i> O157, <i>Plesiomonas<br/>shigelloides, Yersinia<br/>enterocolitica, Astrovirus</i> , and<br><i>Rotavirus A</i> were established<br>primarily with retrospective<br>clinical specimens. | |
| | | Performance characteristics for<br><i>Entamoeba histolytica</i> , and<br><i>Vibrio (V parahaemolyticus, V.<br/>vulnificus, and Vibrio<br/>cholerae)</i> were established<br>primarily using contrived<br>clinical specimens. | |
| | | Negative FilmArray GI Panel<br>results in the setting of clinical<br>illness compatible with<br>gastroenteritis may be due to<br>infection by pathogens that are<br>not detected by this test or non-<br>infectious causes such as<br>ulcerative colitis, irritable<br>bowel syndrome, or Crohn's<br>disease. | |
| | | A gastrointestinal<br>microorganism multiplex<br>nucleic acid-based assay also<br>aids in the detection and | |
| Characteristic | Device | Predicate | |
| | | identification of acute<br>gastroenteritis in the context of<br>outbreaks. | |
| Specimen Type | Preserved stool in Para-Pak C&S<br>or FecalSwab transport media | Stool in Cary-Blair Medium | |
| Analyte Detected | RNA/DNA…