(27 days)
Not Found
No
The description details a standard PCR-based diagnostic test with automated image interpretation based on melt curve analysis, which is a deterministic process, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
No.
This device is an in vitro diagnostic (IVD) test designed to detect and identify specific bacterial, viral, and parasitic nucleic acids to aid in the diagnosis of acute febrile illness. It is not intended for treatment or management decisions, but rather for diagnostic purposes.
Yes
Explanation: The device is explicitly described as detecting and identifying nucleic acids to be "used in conjunction with other clinical, epidemiologic, and laboratory data" for individuals with signs and/or symptoms of acute febrile illness. It helps "diagnose, treat, or other management decisions." This information indicates its role in the diagnostic process.
No
The device is an in vitro diagnostic (IVD) test that includes a physical pouch containing reagents and is used with specific hardware systems (BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH Systems) that perform the PCR reactions and image capture. While software is a critical component for interpreting results, it is part of a larger hardware-based system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "qualitative, multiplexed, polymerase chain reaction (PCR) test intended for use with BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH Systems." It also describes its purpose as detecting and identifying specific pathogens from whole blood specimens to aid in the diagnosis of acute febrile illness. This clearly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The "Device Description" further reinforces this by stating that the device is compatible with "BioFire's PCR-based in vitro diaqnostic BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® FILMARRAY® TORCH Systems for infectious disease testing."
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K220870 - BioFire Global Fever Panel) indicates that this device is being compared to a previously cleared or approved IVD device, which is a common regulatory pathway for IVDs.
Therefore, based on the provided information, the BIOFIRE FILMARRAY TF Panel is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BIOFIRE FILMARRAY Tropical Fever (TF) Panel is an automated qualitative, multiplexed, polymerase chain reaction (PCR) test intended for use with BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH Systems. The BIOFIRE FILMARRAY TF Panel detects and identifies selected bacterial, viral, and parasitic nucleic acids directly from EDTA whole blood collected from individuals with signs and/or symptoms of acute febrile illness or recent acute febrile illness and known or suspected exposure to the following target pathogens: chikungunya virus, dengue virus (serotypes 1, 2, 3 and 4), Leptospira spp., and Plasmodium species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale).
Evaluation for more common causes of acute febrile illness (e.g., infections of the upper and lower respiratory tract or gastroenteritis, as well as non-infectious causes) should be considered prior to evaluation with this panel. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities.
The BIOFIRE FILMARRAY TF Panel is not intended to be used as the sole basis for diagnosis, treatment, or other management decisions. Positive results do not rule out co-infection with other organisms not included on the BIOFIRE FILMARRAY TF Panel, nor do negative results rule out infection. Negative results from the BIOFIRE FILMARRAY TF Panel may require additional testing if clinically indicated. Not all pathogens that cause acute febrile illness are detected by this test, and negative results do not rule out the presence of other infections.
In the United States, patient travel history, exposure risk, and consultation of the CDC Yellow Book should be considered prior to use of the BIOFIRE FILMARRAY TF Panel as some pathogens are more common in certain geographical locations.
Product codes
OMV
Device Description
The BIOFIRE FILMARRAY TF Panel is a rebranded version of the BioFire Global Fever Panel. It is designed to simultaneously identify 6 pathogens from whole blood specimens collected in EDTA tubes. The BIOFIRE FILMARRAY TF Panel is compatible with BioFire's PCR-based in vitro diagnostic BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH Systems for infectious disease testing. A panel-specific software module (i.e., BIOFIRE FILMARRAY TF Panel pouch module software) is used to perform BIOFIRE FILMARRAY TF Panel testing on these systems. Results from the BIOFIRE FILMARRAY TF Panel test are available within about one hour.
A test is initiated by loading Hydration into one port of the pouch and a whole blood or positive blood culture specimen mixed with the provided Sample Buffer into the port of the BIOFIRE FILMARRAY TF Panel pouch and placing it in a BIOFIRE System. The pouch contains all the reagents required for speciment testing and analysis in a freezedried format; the addition of Hydration and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the BIOFIRE Software guides the user through the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.
The BIOFIRE System contains a coordinated system of inflatable bladders and seal points, which act on the pouch to control the movement of liquid between the pouch blisters. When a bladder is inflated over a reagent blister, it forces liquid from the blister into connecting channels. Alternatively, when a seal is placed over a connecting channel it acts as a valve to open or close a channel. In addition, electronically-controlled pneumatic pistons are positioned over multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier devices control heating and cooling of the pouch to drive the PCR reactions and the melt curve analysis.
Nucleic acid extraction occurs within the BIOFIRE pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the BIOFIRE system performs a nested multiplex PCR that is executed in two stages. During the first stage, the BIOFIRE System performs a single, large volume, highly multiplexed reverse transcription PCR reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent double stranded DNA binding dye. The solution is then distributed to each wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 2nd stage PCR, or nested PCR, is performed in single plex fashion in each well of the end of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.
The BIOFIRE Software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel.
Mentions image processing
A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The BIOFIRE FILMARRAY TF Panel is intended for use by trained medical and laboratory professionals in a laboratory setting or under the supervision of a trained laboratory professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K220870 BioFire Global Fever Panel
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3966 Device to detect and identify selected microbial agents that cause acute febrile illness.
(a)
Identification. A device to detect and identify selected microbial agents that cause acute febrile illness is identified as an in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) An intended use that includes a detailed description of targets the device detects and measures, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended.
(ii) Limiting statements indicating:
(A) Not all pathogens that cause febrile illness are detected by this test and negative results do not rule out the presence of other infections;
(B) Evaluation of more common causes of acute febrile illness should be considered prior to evaluation with this test;
(C) Test results are to be interpreted in conjunction with other clinical, epidemiologic, and laboratory data available to the clinician; and
(D) When using this test, consider patient travel history and exposure risk, as some pathogens are more common in certain geographical locations.
(iii) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens.
(iv) Detailed discussion of the performance characteristics of the device for all claimed specimen types as shown by the analytical and clinical studies required under paragraphs (b)(3)(ii) and (iii) of this section, except specimen stability performance characteristics.
(v) A statement that nationally notifiable results are to be reported to public health authorities in accordance with local, state, and federal law.
(3) Design verification and validation must include:
(i) A detailed device description (
e.g., all device parts, control elements incorporated into the test procedure, reagents required but not provided, the principle of device operation and test methodology), and the computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported result).(ii) Detailed documentation of analytical studies, including those demonstrating Limit of Detection (LoD), inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate.
(iii) Detailed documentation and performance results from a clinical study that includes prospective (sequentially collected) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA-accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses.
(iv) A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 5, 2024
BioFire Diagnostics, LLC (bioMerieux) Karli Plenert Sr Director, Regulatory Affairs 515 Colorow Drive Salt Lake City, Utah 84108
Re: K243463
Trade/Device Name: BIOFIRE FILMARRAY Tropical Fever Panel Regulation Number: 21 CFR 866.3966 Regulation Name: Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness Regulatory Class: Class II Product Code: OMV Dated: November 7, 2024 Received: November 8, 2024
Dear Karli Plenert:
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Bryan M. Digitally signed by Bryan M. Grabias -S Grabias -S Date: 2024.12.05 14:24:06 -05'00'
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
3
Indications for Use
510(k) Number (if known) K243463
Device Name BIOFIRE FILMARRAY Tropical Fever Panel
Indications for Use (Describe)
The BIOFIRE FILMARRA Y Tropical Fever (TF) Panel is an automated qualitative, multiplexed, polymerase chain reaction (PCR) test intended for use with BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH Systems. The BIOFIRE FILMARRAY TF Panel detects and identifies selected bacterial, viral, and parasitic nucleic acids directly from EDTA whole blood collected from individuals with signs and/or symptoms of acute febrile illness or recent acute febrile illness and known or suspected exposure to the following target pathogens: chikungunya virus, dengue virus (serotypes 1, 2, 3 and 4), Leptospira spp., and Plasmodium species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale).
Evaluation for more common causes of acute febrile illness (e.g., infections of the upper and lower respiratory tract or gastroenteritis, as well as non-infectious causes) should be considered prior to evaluation with this panel. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities.
The BIOFIRE FILMARRA Y TF Panel is not intended to be used as the sole basis for diagnosis, treatment, or other management decisions. Positive results do not rule out co-infection with other organisms not included on the BIOFIRE FILMARRA Y TF Panel, nor do negative results rule out infection. Negative results from the BIOFIRE FILMARRA Y TF Panel may require additional testing if clinically indicated. Not all pathogens that cause acute febrile illness are detected by this test, and negative results do not rule out the presence of other infections.
In the United States, patient travel history, exposure risk, and consultation of the CDC Yellow Book should be considered prior to use of the BIOFIRE FILMARRAY TF Panel as some pathogens are more common in certain geographical locations.
| 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 |
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4
Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle divided into two sections. The top half of the circle is blue and contains the word "BIOMÉRIEUX" in white, sans-serif font. The bottom half of the circle is a gradient of yellow and green.
BIOFIRE® FILMARRAY® Tropical Fever Panel
Special 510(k) Summary BioFire Diagnostics, LLC
Introduction:
The content of this Special 510(k) submission is limited to obtaining FDA clearance for the BIOFIRE® Tropical Fever (TF) Panel, a rebranded version of the BioFire Global Fever Panel (K220870). According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitted by:
BioFire Diagnostics, LLC (bioMérieux) 515 Colorow Drive Salt Lake City, UT 84108
Contact:
Karli Plenert, MBA Telephone: +1 385-414-4985 Email: Karli.Plenert@biomerieux.com
Date Submitted: November 07, 2024
Device Name and Classification:
Trade Name: BIOFIRE FILMARRAY Tropical Fever (TF) Panel
Requlation Number: 21 CFR 866.3966
Classification Name: Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Predicate Devices:
K220870 - BioFire Global Fever Panel
Background:
The BioFire Global Fever Panel (K220870) is designed, and currently manufactured by BioFire Defense, LLC (a wholly owned subsidiary of bioMérieux, Inc.). The BIOFIRE FILMARRAY Tropical Fever (TF) Panel is a rebranded version of the BioFire Global Fever panel that includes updated pouch module software, product labeling, instructions for use, and a new panel name. The performance claims of the BIOFIRE FILMARRAY TF Panel remain identical to the predicate BioFire Global Fever Panel.
BioFire Defense will remain the legal manufacturer of the BioFire Global Fever Panel. BioFire Diagnostics, LLC (also a wholly owned subsidiary of bioMérieux, lnc.) will be the legal manufacturer of the BIOFIRE FILMARRAY TF Panel and BioFire Defense will be the contract manufacturer for the device.
5
Modifications:
Software Update
The BIOFIRE FILMARRAY TF Panel Pouch Module software has been developed to support the rebranded panel and includes the following changes:
- . Change to the panel name,
- Update to report to align the report appearance and layout with other BIOFIRE FILMARRAY IVD panels sold by bioMérieux, and
- Add cross-compatibility with the latest BIOFIRE FILMARRAY Systems Software. ●
Labeling and Branding Update:
A new BIQFIRE FILMARRAY TF Panel instructions for use has been created to align with bioMérieux branding quidelines for the BIOFIRE product line and reflects the updated panel name. In addition, physical product labeling has been created to include the new product branding and panel name.
Intended Use:
The BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel is an automated, qualitative, multiplexed polymerase chain reaction (PCR) test intended for use with BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® FILMARRAY® TORCH Systems. The BIOFIRE FILMARRAY TF Panel detects and identifies selected bacterial, viral, and parasitic nucleic acids directly from EDTA whole blood collected from individuals with signs and/or symptoms of acute febrile illness and known or suspected exposure to the following target pathogens: chikungunya virus (serotypes 1, 2, 3 and 4), Leptospira spp., and Plasmodium species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale).
Evaluation for more common causes of acute febrile illness (e.g., infections of the upper and lower respiratory tract or gastroenteritis, as well as non-infectious causes) should be considered prior to evaluation with this panel. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities.
The BIOFIRE FILMARRAY TF Panel is not intended to be used as the sole basis for diagnosis, treatment, or other management decisions. Positive results do not rule out co-infection with other organisms not included on the BIOFIRE FILMARRAY TF Panel, nor do negative results rule out infection. Negative results from the BIOFIRE FILMARRAY TF Panel may require additional testing if clinically indicated. Not all pathogens that cause acute febrile illness are detected by this test, and negative results do not rule out the presence of other infections.
In the United States, patient travel history, exposure risk, and consultation of the CDC Yellow Book should be considered prior to use of the BIOFIRE FILMARRAY TF Panel as some pathogens are more common in certain geographical locations.
Intended User and Use Environment
The BIOFIRE FILMARRAY TF Panel is intended for use by trained medical and laboratory professionals in a laboratory setting or under the supervision of a trained laboratory professional.
Device Description:
The BIOFIRE FILMARRAY TF Panel is a rebranded version of the BioFire Global Fever Panel. It is designed to simultaneously identify 6 pathogens from whole blood specimens collected in EDTA tubes. The BIOFIRE FILMARRAY TF Panel is compatible with BioFire's PCR-based in vitro diaqnostic BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® FILMARRAY® TORCH Systems for infectious disease testing. A panel-specific software module (i.e., BIOFIRE FILMARRAY TF Panel pouch module software) is used to perform BIOFIRE FILMARRAY TF Panel testing on these systems. Results from the BIOFIRE FILMARRAY TF Panel test are available within about one hour.
6
A test is initiated by loading Hydration into one port of the pouch and a whole blood or positive blood culture specimen mixed with the provided Sample Buffer into the port of the BIOFIRE FILMARRAY TF Panel pouch and placing it in a BIOFIRE System. The pouch contains all the reacents required for speciment testing and analysis in a freezedried format; the addition of Hydration and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the BIOFIRE Software quides the user though the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.
The BIOFIRE System contains a coordinated system of inflatable bladders and seal points, which act on the pouch to control the movement of liquid between the pouch blisters. When a bladder is inflated over a reagent blister, it forces liquid from the blister into connecting channels. Alternatively, when a seal is placed over a connecting channel it acts as a valve to open or close a channel. In addition, electronically-controlled pneumatic pistons are positioned over multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier devices control heating and cooling of the pouch to drive the PCR reactions and the melt curve analysis.
Nucleic acid extraction occurs within the BIOFIRE pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the BIOFIRE system performs a nested multiplex PCR that is executed in two stages. During the first stage, the BIOFIRE System performs a single, large volume, highly multiplexed reverse transcription PCR (reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent double stranded DNA binding dye. The solution is then distributed to each wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 2nd stage PCR, or nested PCR, is performed in single plex fashion in each well of the end of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.
The BIOFIRE Software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel.
Device Comparison:
Table 1 outlines the similarities and differences between the BIOFIRE FILMARRAY TF Panel with the BioFire Global Fever Panel.
7
Table 1. Comparison of the BIOFIRE FILMARRAY TF Panel with the BioFire Global Fever Panel.
| Element | Modified Device:
BIOFIRE FILMARRAY TF Panel | Predicate:
BioFire Global Fever Panel (K220870) |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel is an
automated, qualitative, multiplexed polymerase chain reaction
(PCR) test intended for use with BIOFIRE® FILMARRAY® 2.0
and BIOFIRE® FILMARRAY® TORCH Systems. The BIOFIRE
FILMARRAY TF Panel detects and identifies selected
bacterial, viral, and parasitic nucleic acids directly from EDTA
whole blood collected from individuals with signs and/or
symptoms of acute febrile illness or recent acute febrile illness
and known or suspected exposure to the following target
pathogens: chikungunya virus, dengue virus (serotypes 1, 2, 3
and 4), Leptospira spp., and Plasmodium spp. (including
species differentiation of Plasmodium falciparum and
Plasmodium vivax/ovale).
Evaluation for more common causes of acute febrile illness
(e.g., infections of the upper and lower respiratory tract or
gastroenteritis, as well as non-infectious causes) should be
considered prior to evaluation with this panel. Results are
meant to be used in conjunction with other clinical,
epidemiologic, and laboratory data, in accordance with the
guidelines provided by the relevant public health authorities.
The BIOFIRE FILMARRAY TF Panel is not intended to be
used as the sole basis for diagnosis, treatment, or other
management decisions. Positive results do not rule out co-
infection with other organisms not included on the BIOFIRE
FILMARRAY TF Panel, nor do negative results rule out
infection. Negative results from the BIOFIRE FILMARRAY TF
Panel may require additional testing if clinically indicated. Not
all pathogens that cause acute febrile illness are detected by
this test, and negative results do not rule out the presence of
other infections.
In the United States, patient travel history, exposure risk, and
consultation of the CDC Yellow Book should be considered
prior to use of the BIOFIRE FILMARRAY TF Panel as some
pathogens are more common in certain geographical
locations. | The BioFire® Global Fever Panel is a qualitative,
multiplexed, nucleic acid-based in vitro
diagnostic test intended for use with BioFire®
FilmArray® 2.0 and BioFire® FilmArray® Torch
Systems. The BioFire Global Fever Panel
detects and identifies selected bacterial, viral,
and protozoan nucleic acids directly from EDTA
whole blood collected from individuals with signs
and/or symptoms of acute febrile illness or recent
acute febrile illness and known or suspected
exposure to the following target pathogens:
chikungunya virus, dengue virus (serotypes 1, 2,
3 and 4), Leptospira spp., and Plasmodium spp.
(including species differentiation of Plasmodium
falciparum and Plasmodium vivax/ovale).
Evaluation for more common causes of acute
febrile illness (e.g., infections of the upper and
lower respiratory tract or gastroenteritis, as well
as non-infectious causes) should be considered
prior to evaluation with this panel. Results are
meant to be used in conjunction with other
clinical, epidemiologic, and laboratory data, in
accordance with the guidelines provided by the
relevant public health authorities.
Positive results do not rule out co-infections with
pathogens not included on the BioFire Global
Fever Panel. Not all pathogens that cause acute
febrile illness are detected by this test, and
negative results do not rule out the presence of
other infections. In the United States, patient
travel history and consultation of the CDC Yellow
Book should be considered prior to use of the
BioFire Global Fever Panel as some pathogens
are more common in certain geographical
locations. |
| Organisms Detected | Leptospira spp.
Chikungunya virus
Dengue virus (serotypes 1, 2, 3 and 4)
Plasmodium spp.
Plasmodium falciparum
Plasmodium vivax/ovale | Same |
| Analyte | DNA/RNA | Same |
| Specimen Types | Whole blood (collected in EDTA tube) | Same |
| Technological
Principles | Nested multiplex PCR followed by high resolution melting
analysis to confirm the identity of amplified product. | Same |
| Instrumentation | BIOFIRE 2.0 System or BIOFIRE TORCH System | Same |
| Time to result | ~ 50 minutes | Same |
| Test Interpretation | Automated test interpretation and report generation. User
cannot access raw data. | Same |
| Sample Preparation
Method | Sample Processing is automated in the BIOFIRE System. | Same |
| Reagent Storage | Reagents are stored at room temperature. | Same |
| Shelf Life | 12 months from Date of Manufacture. | Same |
| Element | Modified Device:
BIOFIRE FILMARRAY TF Panel | Predicate:
BioFire Global Fever Panel (K220870) |
| Controls | Two controls are included in each reagent pouch to control for
sample processing and both stages of PCR and melt analysis. | Same |
| User Complexity | Moderate | Same |
| Legal Manufacturer | *BioFire Diagnostics, LLC. | *BioFire Defense, LLC. |
8
*Note: BioFire Diagnostics, LLC and BioFire Defense, LLC are both wholly owned subsidiaries of bioMérieux, Inc.
Conclusion:
The fundamental scientific technology, performance claims, or risk of the BIOFIRE FILMARRAY TF Panel are unchanged from the legally marketed BioFire Global Fever Panel. There is no change to the product itself, except for updated software that has been verfied and validated to show no change in safety and effectiveness, instructions for use, product labeling, and branding. Therefore, the BIOFIRE FILMARRAY TF Panel is substantially equivalent to its predicate device.