QIAstat-Dx Meningitis/Encephalitis (ME) Panel

K242256 · QIAGEN GmbH · PLO · Oct 29, 2024 · Microbiology

Device Facts

• Record ID: K242256
• Device Name: QIAstat-Dx Meningitis/Encephalitis (ME) Panel
• Applicant: QIAGEN GmbH
• Product Code: PLO · Microbiology
• Decision Date: Oct 29, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3970
• Device Class: Class 2

Intended Use

The QIAstat-Dx® Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid real-time PCR-based in vitro diagnostic test intended for use with the QIAstat-Dx Analyzer 1.0. The QIAstat-Dx ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis. The following organisms are identified using the QIAstat-Dx ME Panel: Enterovirus, Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis (encapsulated), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, and Cryptococcus neoformans/gattii*. The QIAstat-Dx ME Panel is indicated as an aid in the diagnosis of specific agents of meningitis and/or encephalitis and results must be used in conjunction with other clinical, epidemiological, and laboratory data. Results from the QIAstat-Dx ME Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with organisms not included in the QIAstat-Dx ME Panel. The agent or agents detected may not be the definite cause of the disease. Negative results do not preclude central nervous system (CNS) infection. Not all agents of CNS infection are detected by this test and sensitivity in clinical use may differ from that described in the instructions for use. The QIAstat-Dx ME Panel is not intended for testing of specimens collected from indwelling CNS medical devices. The QIAstat-Dx ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.

Device Story

The QIAstat-Dx ME Panel is a single-use, closed-cartridge system for automated molecular diagnostics. It processes CSF specimens to detect bacterial, viral, and yeast pathogens. The user loads the sample into the cartridge, which is then inserted into the QIAstat-Dx Analyzer 1.0. The system performs automated sample preparation, including cell lysis, nucleic acid purification via silica membrane, and real-time multiplex PCR amplification. The analyzer interprets fluorescence signals to identify specific pathogens and displays results on a screen. It is intended for use in clinical laboratory settings to aid in the diagnosis of meningitis and encephalitis. By providing rapid, multiplexed identification of CNS pathogens, the device assists clinicians in making timely patient management and treatment decisions, potentially improving patient outcomes compared to traditional culture-based methods.

Clinical Evidence

Clinical performance was evaluated in a multicenter, prospective, and retrospective study across 13 sites (10 US, 3 Europe) with 1,524 prospective and 41 evaluable archived CSF specimens. Comparator methods included FDA-cleared molecular tests and validated endpoint PCR/sequencing. Overall PPA ranged from 50% to 100% and NPA was >99% across targets. Bench testing included LoD, inclusivity (130 strains), exclusivity (115 off-panel organisms), and interference studies. No carryover was observed. Clinical sensitivity/specificity were also calculated against standard-of-care culture.

Technological Characteristics

Single-use cartridge with pre-packaged wet/dry reagents. Uses silica membrane for nucleic acid purification. Employs real-time multiplex PCR (rtPCR) with fluorescence detection. System includes QIAstat-Dx Analyzer 1.0 for automated processing and interpretation. Dimensions/form factor: cartridge-based. Connectivity: standalone analyzer with optional printer. Sterilization: not specified.

Indications for Use

Indicated for qualitative detection/identification of bacterial, viral, and yeast nucleic acids in CSF from patients with signs/symptoms of meningitis/encephalitis. Not for use with indwelling CNS devices. Results are an aid to diagnosis and must be used with other clinical/lab data.

Regulatory Classification

Identification

A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is a qualitative in vitro device intended for the detection and identification of microbial-associated nucleic acid sequences from patients suspected of meningitis or encephalitis. A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is intended to aid in the diagnosis of meningitis or encephalitis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including primer/probe sequence, design, and rationale for sequence selection. (2) Premarket notification submissions must include detailed documentation from the following analytical studies: Analytical sensitivity (limit of detection), inclusivity, reproducibility, interference, cross reactivity, and specimen stability. (3) Premarket notification submissions must include detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted comparator methods. (4) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, software applications and hardware-based devices that incorporate software. (5) The Intended Use statement in the device labeling must include a statement that the device is intended to be used in conjunction with standard of care culture. (6) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling. (7) The device labeling must include a limitation stating that the negative results do not preclude the possibility of central nervous system infection. (8) The device labeling must include a limitation stating that device results are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. (9) The device labeling must include a limitation stating that positive results do not mean that the organism detected is infectious or is the causative agent for clinical symptoms. (10) As part of the risk management activities performed under 21 CFR 820.10(c) design and development, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.

Predicate Devices

• FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch (K160462)

Submission Summary (Full Text)

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October 29, 2024

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

QIAGEN GmbH % Sonia Pablo Pablo Senior Manager, Regulatory Affairs STAT-Dx Life, S.L. (A QIAGEN Company) Carrer Baldiri Reixac. 4 Barcelona, 08028 Spain

Re: K242256

Trade/Device Name: QIAstat-Dx Meningitis/Encephalitis (ME) Panel Regulation Number: 21 CFR 866.3970 Regulation Name: Device To Detect And Identify Microbial Pathogen Nucleic Acids In Cerebrospinal Fluid Regulatory Class: Class II Product Code: PLO Dated: July 29, 2024 Received: July 31, 2024

Dear Sonia Pablo Pablo:

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"

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(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).

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 (QS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 mediation-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).

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Sincerely, Bryan M. Grabias -S

Digitally signed by Bryan M. Grabias -S Date: 2024.10.29 15:52:56 -04'00'

Bryan Grabias Acting 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

Enclosure

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## Indications for Use

510(k) Number (if known) K242256

#### Device Name QIAstat-Dx Meningitis/Encephalitis (ME) Panel

#### Indications for Use (Describe)

The QIAstat-Dx Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid real-time PCR based in vitro diagnostic test intended for use with the QIAstat-Dx Analyzer 1.0. The QIAstat-Dx ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.

The following organisms are identified using the OlAstat-Dx ME Panel: Enterovirus, Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis (encapsulated), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, and Cryptococcus neoformans/gattii*.

The QIAstat-Dx ME Panel is indicated as an aid in the diagnosis of meningitis and/or encephalitis and results must be used in conjunction with other clinical, endemiological, and laboratory data. Results from the OlAstat-Dx ME Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with organisms not included in the QIAstat-Dx ME Panel. The agents detected may not be the definite cause of the disease. Negative results do not preclude central nervous system infection.

Not all agents of central nervous system infection are detected by this test and sensitivity in clinical use may differ from that described in the instructions for use.

The QIAstat-Dx ME Panel is not intended for testing specimens collected from indwelling central nervous system medical devices.

The QIAstat-Dx ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.

*Cryptococcus neoformans and Cryptococcus gattii are not differentiated.

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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## 510(k) Summary

## General Information

| Submitted by: | QIAGEN GmbH<br>QIAGEN Strasse 1<br>Hilden, Germany 40724 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sonia Pablo<br>Senior Manager, Regulatory Affairs<br>STAT-Dx Life, S.L. (A QIAGEN Company)<br>Carrer Baldiri Reixac, 4<br>08028 Barcelona<br>Spain<br>Phone: [phone]<br>Email: <a href="mailto:[e-mail]">[e-mail]</a> |
| Date Prepared: | October 28, 2024 |
| Device Name: | QIAstat-Dx® Meningitis/Encephalitis (ME) Panel |
| Classification: | 21 CFR 866.3970 - Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid. |
| Product Code: | PLO |
| Predicate Device: | |

| Manufacturer | Product Name | De Novo/510(k) No. |
|--------------------------|----------------------------------------------|--------------------|
| BioFire Diagnostics, LLC | FilmArray Meningitis/Encephalitis (ME) Panel | K160462 |

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#### Device Description

The QIAstat-Dx® Meningitis/Encephalitis (ME) Panel is part of the QIAstat-Dx Meningitis/Encephalitis system and works with the OIAstat-Dx Analyzer 1.0.

The QIAstat-Dx ME Panel is intended to be used with cerebrospinal fluid (CSF) specimens.

Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 80 minutes. When the test is finished, the cartridge is removed by the user and discarded. The OIAstat-Dx Analyzer 1.0 automatically interprets test results and displays a summary on the analyzer display screen. The results can be printed using a connected printer, if needed. The detected analytes are displayed in red. 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").

QIAstat-Dx consists of single-test cartridges with pre-packaged reagents including both wet and dry chemistry necessary to perform the sample preparation, nucleic acid amplification and detection to be used in conjunction with the QIAstat-Dx Analyzer 1.0. All sample preparation and assay steps are performed within the cartridge, so the user does not need to manipulate any reagent during the test. This eliminates exposure of the user or the Analyzer to chemicals contained in the cartridge during the test and up to the disposal of used cartridges.

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

- Resuspension of air-dried internal control and Proteinase K (ProtK) enzyme using . provided buffer and mixing with the liquid sample (IC Cavity and ProtK Cavity);
- Cell lysis using mechanical (rotation) and chemical (chaotropic and isotonic) ● means (lysis chamber):
- Membrane-based nucleic acid purification from Lysate by: ●
- Mixing lysate with binding buffer and capturing on the membrane -(purification chamber);
- First washing of membrane to remove bound proteins (purification chamber and waste chamber);
- Second washing of membrane to leave only bound nucleic acids -(purification chamber and waste chamber);
- Rinsing of Transfer Chamber (TC) using the rinsing buffer before introduction of the eluate (Transfer Chamber);

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- Drying of membrane with bound nucleic acids with an air flow generated by a high flow vacuum pump (purification chamber); and
- Elution of nucleic acids with elution buffer (purification chamber and TC);
- Mixing of the purified nucleic acid (eluate) with lyophilized "Master Mix" reagents ● (Dry chemistry container (DCC) and TC);
- Sequential transfer of defined aliquots of mixed eluate/Master Mix from the ● Transfer Chamber to each of eight Reaction Chambers containing the specified, airdried primers and probes;
- Within each Reaction Chamber, real-time, multiplex PCR ("rtPCR") testing is ● performed. Increase in fluorescence (indicative of detection of each target analyte) is detected directly within each Reaction Chamber; and
- The detected signal per fluorescent marker per Reaction Chamber is then used by the system software to generate the assay result.

#### Intended Use

-

The QIAstat-Dx® Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid real-time PCRbased in vitro diagnostic test intended for use with the QIAstat-Dx Analyzer 1.0. The QIAstat-Dx ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.

The following organisms are identified using the QIAstat-Dx ME Panel: Enterovirus, Escherichia coli K1, Haemophilus influenzae, Listeria monocvtogenes, Neisseria meningitidis (encapsulated), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, and Cryptococcus neoformans/gattii*.

The OIAstat-Dx ME Panel is indicated as an aid in the diagnosis of specific agents of meningitis and/or encephalitis and results must be used in conjunction with other clinical, epidemiological, and laboratory data. Results from the QIAstat-Dx ME Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with organisms not included in the QIAstat-Dx ME Panel. The agent or agents detected may not be the definite cause of the disease. Negative results do not preclude central nervous system (CNS) infection.

Not all agents of CNS infection are detected by this test and sensitivity in clinical use may differ from that described in the instructions for use.

The QIAstat-Dx ME Panel is not intended for testing of specimens collected from indwelling CNS medical devices.

The QIAstat-Dx ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.

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* Cryptococcus neoformans and Cryptococcus gattii are not differentiated.

## Comparison of the QIAstat-Dx ME Panel and the Predicate Device

Similarities and differences between the QIAstat-Dx ME Panel and the predicate device are shown in Table 1.

| Characteristic | Device | Predicate |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | QIAstat-Dx ME Panel | FilmArray<br>Meningitis/Encephalitis (ME)<br>Panel |
| 510(k) No. | K242256 | K160462 |
| Regulation | 21 CFR 866.3970 | 21 CFR 866.3970 |
| Product Code | PLO | PLO |
| Device Class | Class II | Class II |
| Similarities | | |
| Intended Use | The QIAstat-Dx®<br>Meningitis/Encephalitis (ME)<br>Panel is a qualitative multiplexed<br>nucleic acid real-time PCR-based<br><i>in vitro</i> diagnostic test intended<br>for use with the QIAstat-Dx<br>Analyzer 1.0. The QIAstat-Dx<br>ME Panel is capable of<br>simultaneous detection and<br>identification of multiple<br>bacterial, viral, and yeast nucleic<br>acids from cerebrospinal fluid<br>(CSF) specimens obtained via<br>lumbar puncture from individuals<br>with signs and/or symptoms of<br>meningitis and/or encephalitis.<br><br>The following organisms are<br>identified using the QIAstat-Dx<br>ME Panel:<br><br>Bacteria:<br>• Escherichia coli K1<br>• Haemophilus influenzae<br>• Listeria monocytogenes | The FilmArray<br>Meningitis/Encephalitis (ME)<br>Panel is a qualitative<br>multiplexed nucleic acid-based<br><i>in vitro</i> diagnostic test intended<br>for use with FilmArray,<br>FilmArray 2.0, and FilmArray<br>Torch systems. The FilmArray<br>ME Panel is capable of<br>simultaneous detection and<br>identification of multiple<br>bacterial, viral, and yeast<br>nucleic acids directly from<br>cerebrospinal fluid (CSF)<br>specimens obtained via lumbar<br>puncture from individuals with<br>signs and/or symptoms of<br>meningitis and/or encephalitis.<br><br>The following organisms are<br>identified using the FilmArray<br>ME Panel:<br><br>Bacteria:<br>• Escherichia coli K1<br>• Haemophilus influenzae<br>• Listeria monocytogenes |

| | Table 1: Comparison of the QIAstat-Dx ME Panel with the predicate device | | | | | |
|--|--------------------------------------------------------------------------|--|--|--|--|--|
|--|--------------------------------------------------------------------------|--|--|--|--|--|

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510(k) Premarket Notification

Page 5 of 35

| Characteristic | Device | Predicate | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | • Neisseria meningitidis<br>(encapsulated) | • Neisseria meningitidis<br>(encapsulated) | |
| | • Streptococcus agalactiae | • Streptococcus agalactiae | |
| | • Streptococcus pneumoniae | • Streptococcus pneumoniae | |
| | • Streptococcus pyogenes | | |
| | | Viruses: | |
| | Virus: | • Enterovirus | |
| | • Enterovirus | • Cytomegalovirus | |
| | | • Herpes simplex virus 1 | |
| | Yeast: | • Herpes simplex virus 2 | |
| | • Cryptococcus<br>neoformans/gattii* | • Human herpesvirus 6 | |
| | | • Human parechovirus | |
| | | • Varicella zoster virus | |
| | The QIAstat-Dx ME Panel is<br>indicated as an aid in the<br>diagnosis of specific agents of<br>meningitis and/or encephalitis and<br>results must be used in<br>conjunction with other clinical,<br>epidemiological, and laboratory<br>data. Results from the QIAstat-<br>Dx ME Panel are not intended to<br>be used as the sole basis for<br>diagnosis, treatment, or other<br>patient management decisions.<br>Positive results do not rule out co-<br>infection with organisms not<br>included in the QIAstat-Dx ME<br>Panel. The agent or agents<br>detected may not be the definite<br>cause of the disease. Negative<br>results do not preclude central<br>nervous system (CNS) infection.<br><br>Not all agents of CNS infection<br>are detected by this test and<br>sensitivity in clinical use may | | |
| | | Yeast: | |
| | | • Cryptococcus<br>neoformans/gattii | |
| | | The FilmArray ME Panel is<br>indicated as an aid in the<br>diagnosis of specific agents of<br>meningitis and/or encephalitis<br>and<br>results are meant to be used in<br>conjunction with other clinical,<br>epidemiological, and laboratory<br>data. Results from the<br>FilmArray ME Panel are not<br>intended to be used as the sole<br>basis for diagnosis, treatment, or<br>other patient management<br>decisions. Positive results do not<br>rule out co-infection with<br>organisms not included in the<br>FilmArray ME Panel. The agent<br>detected may not be the definite<br>cause of the disease. Negative<br>results do not preclude central<br>nervous system (CNS)<br>infection. Not all agents of CNS<br>infection are detected by this<br>test and sensitivity in clinical<br>use may differ from that | |
| Characteristic | Device | Predicate | |
| | differ from that described in the<br>instructions for use. | described in the package insert. | |
| | The QIAstat-Dx ME Panel is not<br>intended for testing of specimens<br>collected from indwelling CNS<br>medical devices. | The FilmArray ME Panel is not<br>intended for testing of<br>specimens collected from<br>indwelling CNS medical<br>devices. | |
| | The QIAstat-Dx ME Panel is<br>intended to be used in conjunction<br>with standard of care culture for<br>organism recovery, serotyping, and<br>antimicrobial susceptibility testing. | The FilmArray ME Panel is<br>intended to be used in<br>conjunction with standard of<br>care culture for organism<br>recovery,<br>serotyping, and antimicrobial<br>susceptibility testing. | |
| | * Cryptococcus neoformans and<br>Cryptococcus gattii are not<br>differentiated. | | |
| Specimen Type | Cerebrospinal Fluid | Cerebrospinal Fluid | |
| Analyte Detected | RNA/DNA | RNA/DNA | |
| Organisms<br>Detected | See above | See above | |
| Amplification and<br>Detection<br>Technology | PCR | PCR | |
| Differences |…