(27 days)
Not Found
No
The description details a standard nucleic acid amplification and detection process with software interpretation of melt curve data. There is no mention of AI or ML algorithms being used for analysis or interpretation.
No
This device is an in vitro diagnostic test designed to detect and identify nucleic acids from various pathogens in cerebrospinal fluid, which aids in diagnosis, rather than providing direct therapy or treatment.
Yes
The FilmArray ME Panel is explicitly described as an "in vitro diagnostic test" and is "intended as an aid in the diagnosis of meningitis and/or encephalitis." It detects and identifies multiple bacterial, viral, and yeast nucleic acids from CSF specimens to assist in diagnosis.
No
The device description explicitly details hardware components like the FilmArray instrument, pouches containing reagents, inflatable bladders, seal points, pneumatic pistons, Peltier devices, and a digital camera, all of which are integral to the device's function. While software is mentioned for guiding the user and interpreting data, it is part of a larger system that includes significant hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section:
"The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray, FilmArray Torch systems."
This statement directly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray, FilmArray Torch systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly 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 FilmArray ME Panel:
Bacteria:
- · Escherichia coli K 1
- · Haemophilus influenzae
- · Listeria monocytogenes
- · Neisseria meningitidis (encapsulated)
- · Streptococcus agalactiae
- Streptococcus pneumoniae
Viruses:
- · Cytomegalovirus
- · Enterovirus
- Herpes simplex virus 1
- Herpes simplex virus 2
- · Human herpesvirus 6
- Human parechovirus
- Varicella zoster virus
Yeast:
- · Cryptococcus neoformans/gattii
The FilmArray ME Panel is indicated as an aid in the diagnosis of meningitis and/or encephalitis and results are meant to be used in conjunction with other clinical, epidemiological, and laboratory data. Results from the FilmArray 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 agent 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 package insert.
The FilmArray ME Panel is not intended for testing of specimens collected from indwelling CNS medical devices.
The FilmArray ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.
Product codes
PLO
Device Description
The FilmArray Meningitis/Encephalitis (ME) Panel is a multiplex nucleic acid test designed to be used with FilmArray systems. The FilmArray ME pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR with DNA melt analysis. The FilmArray Meningitis/Encephalitis (ME) Panel simultaneously conducts 14 tests for the identification of potential CNS pathogens from CSF specimens obtained via lumbar puncture (Table 1). Results from the FilmArray ME Panel test are available within about one hour.
A test is initiated by loading Hydration Solution into one port of the FilmArray pouch and a CSF sample mixed with the provided Sample Buffer into the other port of the FilmArray ME pouch and placing it in the FilmArray Instrument. The pouch contains all of the reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration Solution and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the FilmArray Software guides the user through the steps of placing the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.
The FilmArray instrument 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 valye 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 FilmArray pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, a nested multiplex PCR is executed in two stages. During the first stage, a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction is performed. 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 (LC Green® Plus, BioFire Defense, LLC). The solution is then distributed to each well of the array. Array 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 each well of the array. At the conclusion of the 21d 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 array captures fluorescent images of the PCR2 reactions and software interprets the data.
The FilmArray 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central Nervous System (CNS) from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture.
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, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics of FilmArray ME Panel on FilmArray Torch: Contrived samples containing each FilmArray ME Panel analyte at low positive levels (1x LoD) were tested on three complete FilmArray Torch systems (12 FilmArray Torch Modules per system) over five days (30 replicates per analyte per system for 90 total replicates per analyte). Reproducible detection at LOD was confirmed for each FilmArray ME analyte with the expected Detected results for ≥95.6% of samples tested on FilmArray Torch systems. Agreement with the expected negative results (Not Detected) was >98% for each analyte.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reproducible detection at LOD was confirmed for each FilmArray ME analyte with the expected Detected results for ≥95.6% of samples tested on FilmArray Torch systems. Agreement with the expected negative results (Not Detected) was >98% for each analyte.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
(a)
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.(b)
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 as part of your 21 CFR 820.30 design controls, 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Public Health Service
March 17, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BIOFIRE DIAGNOSTICS, LLC KRISTEN KANACK, PHD VICE PRESIDENT, REGULATED PRODUCTS & CLINICAL AFFAIRS 390 WAKARA WAY SALT LAKE CITY UT 84108
Re: K160462
Trade/Device Name: FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch Regulation Number: 21 CFR 866.3970 Regulation Name: Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid Regulatory Class: II Product Code: PLO Dated: February 18, 2016 Received: February 19, 2016
Dear Dr. Kanack:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Steven R. Gitterman -S
For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160462
Device Name
FilmArray Meningitis/Encephalitis (ME) Panel
Indications for Use (Describe)
The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray, FilmArray Torch systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly 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 FilmArray ME Panel:
Bacteria:
- · Escherichia coli K 1
- · Haemophilus influenzae
- · Listeria monocytogenes
- · Neisseria meningitidis (encapsulated)
- · Streptococcus agalactiae
- Streptococcus pneumoniae
Viruses:
- · Cytomegalovirus
- · Enterovirus
- Herpes simplex virus 1
- Herpes simplex virus 2
- · Human herpesvirus 6
- Human parechovirus
- Varicella zoster virus
Yeast:
- · Cryptococcus neoformans/gattii
The FilmArray ME Panel is indicated as an aid in the diagnosis of meningitis and/or encephalitis and results are meant to be used in conjunction with other clinical, epidemiological, and laboratory data. Results from the FilmArray 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 agent 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 package insert.
The FilmArray ME Panel is not intended for testing of specimens collected from indwelling CNS medical devices.
The FilmArray ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.
| 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)
3
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4
Special 510(k) Summary BioFire Diagnostics, LLC
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
Introduction: 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 390 Wakara Way Salt Lake City, UT 84108
Contact:
Kristen J. Kanack, Ph.D. Telephone: 801-736-6354, ext. 330 Fax: 801-588-0507 Email: Kristen.kanack@biofiredx.com
Date Submitted:
February 18, 2016
Trade Name: FilmArray Meningitis/Encephalitis (ME) Panel
Classification Name:
21 CFR 866.3970 – Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
Predicate Device: DEN150013 - FilmArray Meningitis/Encephalitis (ME) Panel
Intended Use:
The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acidbased in vitro diagnostic test intended for use with FilmArray systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly 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 FilmArray ME Panel:
Bacteria:
- Escherichia coli K1 .
- Haemophilus influenzae
- Listeria monocytogenes
- Neisseria meningitidis (encapsulated)
- . Streptococcus agalactiae
- . Streptococcus pneumoniae
BioFire Diagnostics, LLC Special 510(k) FilmArray Torch ME Panel
5
Viruses:
- . Cytomegalovirus
- Enterovirus
- Herpes simplex virus 1
- Herpes simplex virus 2 .
- Human herpesvirus 6
- Human parechovirus ●
- . Varicella zoster virus
Yeast:
- . Cryptococcus neoformans/gattii
The FilmArray ME Panel is indicated as an aid in the diagnosis of specific agents of meningitis and/or encephalitis and results are meant to be used in conjunction with other clinical, epidemiological, and laboratory data. Results from the FilmArray 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 FilmArray ME Panel. The agent 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 package insert.
The FilmArray ME Panel is not intended for testing of specimens collected from indwelling CNS medical devices.
The FilmArray ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.
Device Description:
The FilmArray Meningitis/Encephalitis (ME) Panel is a multiplex nucleic acid test designed to be used with FilmArray systems. The FilmArray ME pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR with DNA melt analysis. The FilmArray Meningitis/Encephalitis (ME) Panel simultaneously conducts 14 tests for the identification of potential CNS pathogens from CSF specimens obtained via lumbar puncture (Table 1). Results from the FilmArray ME Panel test are available within about one hour.
| Bacteria | Viruses |
|---|---|
| Escherichia coli K1 | Cytomegalovirus (CMV) |
| Haemophilus influenzae | Enterovirus (EV) |
| Listeria monocytogenes | Herpes simplex virus 1 (HSV 1) |
| Neisseria meningitidis | Herpes simplex virus 2 (HSV 2) |
| Streptococcus agalactiae | Human herpesvirus 6 (HHV-6) |
| Streptococcus pneumoniae | Human parechovirus (HPeV) |
| Yeast | Varicella zoster virus (VZV) |
| Cryptococcus neoformans/gattii |
| Table 1. Analytes identified by the FilmArray ME Panel |
|---|
6
A test is initiated by loading Hydration Solution into one port of the FilmArray pouch and a CSF sample mixed with the provided Sample Buffer into the other port of the FilmArray ME pouch and placing it in the FilmArray Instrument. The pouch contains all of the reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration Solution and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the FilmArray Software guides the user through the steps of placing the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.
The FilmArray instrument 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 valye 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 FilmArray pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, a nested multiplex PCR is executed in two stages. During the first stage, a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction is performed. 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 (LC Green® Plus, BioFire Defense, LLC). The solution is then distributed to each well of the array. Array 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 each well of the array. At the conclusion of the 21d 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 array captures fluorescent images of the PCR2 reactions and software interprets the data.
The FilmArray 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:
The purpose of this submission is to add FilmArray Torch as an additional instrument system for use with the FilmArray Meningitis/Encephalitis (ME) Panel. There have been no changes to the previously cleared FilmArray ME Panel reagent kit itself. In order to increase throughput capacity, the FilmArray 2.0 was modified to develop the FilmArray Torch by organizing densely packaged instruments (now called FilmArray Torch Modules) into a "tower" configuration having the computer with touchscreen interface incorporated into the system base. Pouches are now inserted horizontally rather than from the top. This configuration allows the FilmArray Torch Modules to be stacked directly on top of each other to minimize system footprint.
7
The following table compares the FilmArray ME Panel for use with the FilmArray Torch to the previously cleared FilmArray ME Panel for Use with the FilmArray 2.0 (DEN150013). The table outlines the similarities and differences between the two systems.
| Element | Modified Device:
FilmArray Meningitis/Encephalitis (ME)
Panel for use with FilmArray Torch | Predicate:
FilmArray Meningitis/Encephalitis (ME)
Panel for use with FilmArray 2.0
(DEN150013) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Organisms
Detected | Bacteria:
• Escherichia coli K1
• Haemophilus influenzae
• Listeria monocytogenes
• Neisseria meningitidis
(encapsulated)
• Streptococcus agalactiae
• Streptococcus pneumoniae
Viruses:
• Cytomegalovirus
• Enterovirus
• Herpes simplex virus 1
• Herpes simplex virus 2
• Human herpesvirus 6
• Human parechovirus
• Varicella zoster virus
Yeast:
• Cryptococcus neoformans/gattii | Same |
| Analyte | RNA/DNA | Same |
| Specimen Types | Cerebrospinal Fluid | Same |
| Technological
Principles | Nested multiplex RT-PCR followed by high
resolution melting analysis to confirm
identity of amplified product. | Same |
| Instrumentation | Single instrument FilmArray System,
FilmArray 2.0 System, or
FilmArray Torch System | Single instrument FilmArray system or
FilmArray 2.0 system |
| Instrument-
Software
Communication | Communication for multiple FilmArray
Torch Modules travels via Ethernet
cable/port. | Same (multiple instruments) |
| Time to result | About 1 hour | Same |
| Test
Interpretation | Automated test interpretation and report
generation. User cannot access raw data. | Same |
| Reagent
Hydration and
Sample Loading | FilmArray Injection Vial-based loading
procedure | Same |
| Sample | Sample Processing is automated in the | Same |
| Table 2. Comparison of the FilmArray Meningitis/Encephalitis Panel for use with the FilmArray Torch to the | |
|---|---|
| current FilmArray Meningitis/Encephalitis Panel. |
8
| Element | Modified Device:
FilmArray Meningitis/Encephalitis (ME)
Panel for use with FilmArray Torch | Predicate:
FilmArray Meningitis/Encephalitis (ME)
Panel for use with FilmArray 2.0
(DEN150013) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Preparation
Method | FilmArray ME pouch. | |
| Reagent Storage | Reagents are stored at room temperature. | Same |
| 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/Low | Same |
Performance Characteristics of FilmArray ME Panel on FilmArray Torch
Contrived samples containing each FilmArray ME Panel analyte at low positive levels (1x LoD) were tested on three complete FilmArray Torch systems (12 FilmArray Torch Modules per system) over five days (30 replicates per analyte per system for 90 total replicates per analyte). Reproducible detection at LOD was confirmed for each FilmArray ME analyte with the expected Detected results for ≥95.6% of samples tested on FilmArray Torch systems. Agreement with the expected negative results (Not Detected) was >98% for each analyte.
Conclusion:
The intended use and fundamental scientific technology of the FilmArray ME Panel used with the modified device, FilmArray Torch, is unchanged from use of the legally marketed FilmArray ME Panel on FilmArray and FilmArray 2.0 systems. Non-clinical validation studies have established that the performance characteristics of FilmArray ME, including reproducibility, are substantially equivalent on FilmArray, FilmArray 2.0, and FilmArray Torch. These data demonstrate that the device performs as well as the predicate device.