(209 days)
Not Found
No
The summary describes a nucleic acid-based diagnostic test and its associated control kit, along with the addition of a new instrument platform. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the detection of specific pathogens through molecular methods and the performance characteristics of the test on different instrument systems.
No.
This device is an in vitro diagnostic test designed to detect and identify nucleic acids from specific pathogens, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "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." This directly identifies it as a diagnostic test.
No
The device is an in vitro diagnostic test that requires specific hardware systems (BioFire FilmArray 2.0 and BioFire FilmArray Torch Systems) to function. While the submission mentions software modifications, the core device is a nucleic acid-based test kit used with hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section: "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."
Furthermore, the document includes the statement "For In Vitro Diagnostic Use." at the end of the "Intended Use / Indications for Use" section.
N/A
Intended Use / Indications for Use
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 illness or recent 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 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.
For In Vitro Diagnostic Use.
Product codes
QMV, PMN
Device Description
The BioFire Global Fever Panel is a multiplexed nucleic acid-based test for the detection and identification of six pathogens which cause acute febrile illness (AFI) from whole blood specimens on BioFire FilmArray systems. The BioFire Global Fever Panel detects and identifies the following pathogens: chikungunya virus, dengue virus, Leptospira spp., and Plasmodium spp., including species differentiation between P. falciparum and P. vivax/ovale. The BioFire Global Fever Panel was originally described and was granted De Novo classification in DEN200043.
The BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel is an assayed quality control intended for monitoring the diagnostic performance of the BioFire Global Fever Panel. The Control Kit consists of Positive and Negative External Controls in a FilmArray Control Injection Vial format. The Positive External Control contains external assayed quality control material consisting of a set of non-infectious DNA segments dried on the filter of a FilmArray Control Injection Vial and detected by the Global Fever Panel. The Negative External Control contains no DNA and is also provided in the Control Injection Vial format. Analysis of the controls is carried out by specific pouch modules that are included in the BioFire Global Fever Panel Pouch Module Package. The BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel was fully described and cleared in K202382.
The purpose of this submission is to add BioFire FilmArray Torch as an additional instrument system for use with the BioFire Global Fever Panel and BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel, which were previously marketed for use with BioFire FilmArray 2.0 Systems. The FilmArray Torch is a modular configuration of the FilmArray 2.0 that minimizes instrument footprint by stacking up to twelve individual FilmArray Torch Modules on top of a single FilmArray Torch System Base. This 510(k) request describes modifications to the BioFire Global Fever Panel Pouch Module Package software and validation efforts to support adding FilmArray Torch Systems to the intended use of both the BioFire Global Fever Panel and associated BIOFIRE SHIELD Control Kit.
Mentions image processing
Not Found
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
Not Found
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: Reproducibility Study
Sample Size:
BioFire Global Fever Panel - 1080 total replicates (90 replicates per sample per platform x 2 platforms x 6 distinct samples (3 positive, 3 negative, for Leptospira, Dengue, Plasmodium))
BIOFIRE SHIELD Control Kit - 270 total replicates (135 replicates for Positive External Control + 135 replicates for Negative External Control)
Standalone Performance: Overall agreement with expected results for the BioFire Global Fever Panel on the BioFire FilmArray Torch platform was 98.9% as compared to 99.4% on the BioFire FilmArray 2.0 platform.
Key Results:
BioFire Global Fever Panel: Performance on the BioFire FilmArray Torch platform was similar to performance on the BioFire FilmArray 2.0 platform.
BIOFIRE SHIELD Control Kit: Overall agreement with the expected results was 99.6%.
Key Metrics
All FA 2.0 Systems: 1073/1080 (99.4%) [98.7-99.7%]
All FA Torch Systems: 1068/1080 (98.9%) [98.1-99.4%]
Overall Agreement with Expected Result for BIOFIRE SHIELD Control Kit: 269/270 (99.6%) [97.9-99.9%]
Predicate Device(s)
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
BioFire Defense, LLC David Rabiger Associate Director of Regulatory, Quality, and Clinical Affairs 79 W 4500 S. Suite 14 Salt Lake City, Utah 84107
Re: K220870
Trade/Device Name: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global 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: QMV, PMN Dated: March 24, 2022 Received: March 25, 2022
Dear David Rabiger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
mdr-how-report-medical-device-problems.
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Noel Gerald Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220870
Device Name BioFire® Global Fever Panel
Indications for Use (Describe)
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 illness or recent 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 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.
For In Vitro Diagnostic Use.
| 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) |
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3
510(k) Summary
I. Submitter
BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City, UT 84107 Phone: (801) 262-3592 Fax: (801) 447-6907
Contact Person: David Rabiger, Ph.D. Date Prepared: 2022-03-24
II. Device
Name of Device: BioFire® Global Fever Panel Common or Usual Name: Same Regulation: 21 CFR 866.3966 Classification Name: Device to detect and identify selected microbial agents that cause acute febrile illness Product Code: QMV Regulatory Class: Class II (Special Controls) Panel: Microbiology - 83
Name of Device: BioFire® SHIELD™ Control Kit for the BioFire® Global Fever Panel Common or Usual Name: Same Regulation: 21 CFR 866.3920 Classification Name: Assayed quality control material for clinical microbiology assays Product Code: PMN Regulatory Class: Class II (Special Controls) Panel: Microbiology - 83
III. Predicate Devices
BioFire® Global Fever Panel (BioFire Defense, LLC) [DEN200043] This predicate has not been subject to a design-related recall.
BioFire® SHIELD™ Control Kit for the BioFire® Global Fever Panel (BioFire Defense, LLC) [K202382]
This predicate has not been subject to a design-related recall.
4
IV. Device Description
The BioFire Global Fever Panel is a multiplexed nucleic acid-based test for the detection and identification of six pathogens which cause acute febrile illness (AFI) from whole blood specimens on BioFire FilmArray systems. The BioFire Global Fever Panel detects and identifies the following pathogens: chikungunya virus, dengue virus, Leptospira spp., and Plasmodium spp., including species differentiation between P. falciparum and P. vivax/ovale. The BioFire Global Fever Panel was originally described and was granted De Novo classification in DEN200043.
The BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel is an assayed quality control intended for monitoring the diagnostic performance of the BioFire Global Fever Panel. The Control Kit consists of Positive and Negative External Controls in a FilmArray Control Injection Vial format. The Positive External Control contains external assayed quality control material consisting of a set of non-infectious DNA segments dried on the filter of a FilmArray Control Injection Vial and detected by the Global Fever Panel. The Negative External Control contains no DNA and is also provided in the Control Injection Vial format. Analysis of the controls is carried out by specific pouch modules that are included in the BioFire Global Fever Panel Pouch Module Package. The BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel was fully described and cleared in K202382.
The purpose of this submission is to add BioFire FilmArray Torch as an additional instrument system for use with the BioFire Global Fever Panel and BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel, which were previously marketed for use with BioFire FilmArray 2.0 Systems. The FilmArray Torch is a modular configuration of the FilmArray 2.0 that minimizes instrument footprint by stacking up to twelve individual FilmArray Torch Modules on top of a single FilmArray Torch System Base. This 510(k) request describes modifications to the BioFire Global Fever Panel Pouch Module Package software and validation efforts to support adding FilmArray Torch Systems to the intended use of both the BioFire Global Fever Panel and associated BIOFIRE SHIELD Control Kit.
5
Intended Use V.
BioFire Global Fever Panel Intended Use:
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.
For In Vitro Diagnostic Use.
6
BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel Intended Use:
The BIOFIRE® SHIELD™ Control Kit for the BioFire® Global Fever Panel contains Positive and Negative External Controls intended for use as assayed quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of 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) when using the BioFire® Global Fever Panel on BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems. The BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel is designed for and intended to be used solely with the BioFire Global Fever Panel. This product does not replace manufacturer internal controls provided as part of the BioFire Global Fever Panel device.
Both the Positive and Negative External Controls are provided in a FilmArray Control Injection Vial format. The Positive Control Injection Vial contains dried synthetic DNA segments in buffer and stabilizer to assess the presence of each individual assay on the BioFire Global Fever Panel. The Negative Control Injection Vial contains no DNA and is non-reactive with the BioFire Global Fever Panel assays.
Substantial Equivalence VI.
The purpose of this 510(k) submission is to add BioFire FilmArray Torch systems to the intended use of both the BioFire Global Fever Panel and the BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel. No changes have been made to the BioFire Global Fever Panel or BIOFIRE SHIELD Control Kit themselves. Only minor modifications to the BioFire Global Fever Panel Pouch Module Package have been made to add compatibility with BioFire FilmArray Torch systems.
The BioFire Global Fever Panel for use with BioFire FilmArray Torch (BioFire Global Fever Panel v2.1) is substantially equivalent to the BioFire Global Fever Panel v2.0. Table 1 compares the BioFire Global Fever Panel v2.1 to the previously granted BioFire Global Fever Panel v2.0.
7
| Table 1. BioFire Global Fever Panel Predicate Comparison | ||
|---|---|---|
| Element | Subject Device:
BioFire Global Fever Panel | Predicate:
BioFire Global Fever Panel
[DEN200043] |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Specimen Type | Whole blood (collected in EDTA tube) | Same as subject device |
| Intended Use | Individuals with signs and/or symptoms of
acute febrile illness and known or
suspected exposure to pathogens on the
panel | Same as subject device |
| Pathogens Detected | Chikungunya virus, dengue virus (serotypes
1, 2, 3, and 4), Leptospira spp., Plasmodium
spp. (including species differentiation of P.
falciparum and P. vivax/ovale. | Same as subject device |
| Analyte | RNA/DNA | Same as subject device |
| Technological Principles | Highly multiplexed, nested, nucleic acid
amplification test with melt analysis | Same as subject device |
| Instrumentation | BioFire FilmArray 2.0 or BioFire FilmArray
Torch systems | BioFire FilmArray 2.0 systems |
| Time to Result | ~1 hour | Same as subject device |
| Reagent Storage | Room temperature | Same as subject device |
| Test Interpretation | Automated test interpretation and report
generation; user cannot access raw data | Same as subject device |
| Controls | Two controls are included in each reagent
pouch to control for sample processing and
both stages of PCR and melt analysis | Same as subject device |
| Assayed External Controls | BIOFIRE SHIELD Control Kit for the BioFire
Global Fever Panel (Part No. DFA2-ASY-
0006) | Same as subject device |
| User Complexity | Moderate | Same as subject device |
8
The BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel for use with BioFire FilmArray Torch is substantially equivalent to the previously cleared BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel. Table 2 outlines the similarities and differences between the two control kits.
| Element | Subject Device:
BIOFIRE SHIELD Control Kit for the
BioFire Global Fever Panel | Predicate:
BIOFIRE SHIELD Control Kit for the
BioFire Global Fever Panel
[K202382] |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | Positive and negative external assayed
quality controls to monitor assay
performance in the BioFire Global
Fever Panel | Same as subject device |
| Physical Format | External control material dried on
Control Injection Vial filter | Same as subject device |
| Composition | Tm-shifted synthetic DNA (positive
control only) | Same as subject device |
| Targets Monitored | Chikungunya virus, dengue virus
(serotypes 1, 2, 3, and 4), Leptospira
spp., and Plasmodium spp. (including
species differentiation of P. falciparum
and P. vivax/ovale. | Same as subject device |
| Instrumentation | BioFire Global Fever Panel run on
BioFire FilmArray 2.0 or BioFire
FilmArray Torch systems | BioFire Global Fever Panel run on BioFire
FilmArray 2.0 systems |
| Test Interpretation | Automated test interpretation and
report generation; user cannot access
raw data | Same as subject device |
| Reagent Storage | Room temperature | Same as subject device |
| Table 2. BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel Predicate Comparison | |||||
|---|---|---|---|---|---|
Summarv of Performance Data VII.
Performance of the BioFire Global Fever Panel on BioFire FilmArray Torch Systems
Negative samples containing no analyte and contrived samples containing representative pathogens on the BioFire Global Fever Panel at concentrations near the limit of detection (LoD) were tested in parallel on three BioFire FilmArray 2.0 systems and three BioFire FilmArray Torch systems. Testing was performed over five days by two operators per system for a total of 90 replicates per sample per platform. The performance of the BioFire Global Fever Panel on the BioFire FilmArray Torch platform was similar to performance on the BioFire FilmArray 2.0 platform. Overall agreement with expected results for the BioFire Global Fever Panel on the BioFire FilmArray Torch platform was 98.9% as compared to 99.4% on the BioFire FilmArrav 2.0 platform. Detection rates and percent agreement between observed and expected test results are shown in Table 3.
9
| Analyte
(Source / ID) | Concentration
Tested
(copies/mL) | Expected
Result | FilmArray 2.0 Platform
Detection Rate (n/N)
% Agreement with Expected Result | | | All FA 2.0
Systems
[95% CI] | FilmArray Torch Platform
Detection Rate (n/N)
% Agreement with Expected Result | | | All FA Torch
Systems
[95% CI] |
|----------------------------------------------------------------------------|-----------------------------------------|--------------------|------------------------------------------------------------------------------------|----------------|----------------|------------------------------------|--------------------------------------------------------------------------------------|----------------|----------------|-------------------------------------|
| | | | System 1 | System 2 | System 3 | | System 1 | System 2 | System 3 | |
| Leptospira interrogans
serovar
icterohaemorrhagiae
(ATTC / 23581) | Moderate Positive
3xLoD
(1.0E+03) | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] |
| | Low Positive
1xLoD
(3.4E+02) | Detected | 29/30
96.7% | 29/30
96.7% | 28/30
93.3% | 86/90
95.6%
[89.1-98.3%] | 29/30
96.7% | 28/30
93.3% | 28/30
93.3% | 85/90
94.4%
[87.6-97.6%] |
| | Negative
(No Analyte) | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] |
| Dengue virus
DENV-2
New Guinea C
(Zeptometrix /
0810089CF) | Moderate Positive
3xLoD
(1.0E+03) | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] |
| | Low Positive
1xLoD
(3.4E+02) | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] | 30/30
100% | 29/30
96.7% | 30/30
100% | 89/90
98.9%
[94.0-99.8%] |
| | Negative
(No Analyte) | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] | 30/30
100% | 30/30
100% | 29/30
96.7% | 89/90
98.9%
[94.0-99.8%] |
| Plasmodium
spp.
Plasmodium
falciparum
IPC 4884 | Moderate Positive
3xLoD
(5.4E+02) | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] |
| | Low Positive
1xLoD
(1.8E+02) | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] |
| | Negative
(No Analyte) | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] |
| (BEI / MRA-1238) | Moderate Positive
3xLoD
(5.4E+02) | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] | 30/30
100% | 29/30
96.7% | 30/30
100% | 89/90
98.9%
[94.0-99.8%] |
| | Low Positive
1xLoD
(1.8E+02) | Detected | 30/30
100% | 28/30
93.3% | 29/30
96.7% | 87/90
96.7%
[90.7-98.9%] | 30/30
100% | 28/30
93.3% | 28/30
93.3% | 86/90
95.6%
[89.1-98.3%] |
| | Negative
(No Analyte) | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
[95.9-100%] |
| Overall Agreement with
Expected Result | | All Concentrations | All Results | | | 1073/1080
99.4%
[98.7-99.7%] | | | | 1068/1080
98.9%
[98.1-99.4%] |
Table 3. Reproducibility of the BioFire Global Fever Panel on BioFire FilmArray Platforms
Abbreviations: FA – FilmArray; 95% CI – 95% Confidence Interval
10
Performance of the BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel on BioFire FilmArray Torch Systems
Reproducibility of the BIOFIRE SHIELD Control Kit on the BioFire FilmArray Torch platform was evaluated by testing Positive External Controls and Negative External Controls on three BioFire FilmArray Torch systems over five days by two users per system for a total of 135 replicates for each control type. Overall agreement with the expected results was 99.6%. Results are summarized in Table 4.
| SHIELD Control Type | Expected Result | Observed/Expected
(Percent Agreement) | | | |
|----------------------------------------|-----------------|------------------------------------------|-----------------|------------------------------------|--------------------------------------|
| | | Torch System 1 | Torch System 2 | Torch System 3 | Overall
[95% Confidence Interval] |
| Positive | Passed | 45/45
(100%) | 45/45
(100%) | 45/45
(100%) | 135/135
(100%)
[97.2-100%] |
| Negative | Passed | 44/45
(97.8%) | 45/45
(100%) | 45/45
(100%) | 134/135
(99.3%)
[95.9-99.9%] |
| Overall Agreement with Expected Result | | | | 269/270
(99.6%)
[97.9-99.9%] | |
| Table 4. Reproducibility of the BIOFIRE SHIELD Control Kit on the BioFire FilmArray Torch Platform |
|---|