(87 days)
Not Found
No
The description focuses on nucleic acid amplification and melt curve analysis interpreted by standard software, with no mention of AI or ML algorithms for data interpretation or decision making.
No
The device is an in vitro diagnostic test for identification of pathogens and antimicrobial resistance genes from positive blood culture samples; it is not used to treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the FilmArray Blood Culture Identification (BCID) Panel is a "qualitative multiplexed nucleic acid-based in vitro diagnostic test" and is "indicated as an aid in the diagnosis of specific agents of bacteremia and fungemia".
No
The device description explicitly details hardware components like the FilmArray system, pouches with reagents, inflatable bladders, seal points, pneumatic pistons, Peltier devices, and a digital camera, all of which are integral to the device's function.
Based on the provided text, the device is explicitly stated to be an IVD (In Vitro Diagnostic).
Here's why:
- The "Intended Use / Indications for Use" section clearly states: "The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems."
This statement directly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray BCID Panel is capable of simultaneous detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants of antimicrobial resistance. The BCID assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system that demonstrate the presence of organisms as determined by Gram stain.
The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using the FilmArray BCID Panel: Enterococci, Listeria monocytogenes, Staphylococci (including specific differentiation of Staphylococcus aureus), Streptococci (with specific differentiation of Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes), Acinetobacter baumannii, Enterobacteriaceae (including specific differentiation of the Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and Serratia marcescens), Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, and Candida tropicalis.
The FilmArray BCID Panel also contains assays for the detection of genetic determinants of resistance to methicillin (mecA), vancomycin (vanA and vanB), and carbapenems (blakpr) to aid in the identification of potentially antimicrobial resistant organisms in positive blood culture samples. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, and carbapenems exist.
FilmArray BCID is indicated as an aid in the diagnosis of specific agents of bacteremia and fungemia and results should be used in conjunction with other clinical and laboratory findings. Positive FilmArray results do not rule out co-infection with organisms not included in the FilmArray BCID Panel. FilmArray BCID is not intended to monitor treatment for bacteremia or fungemia.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not detected by the FilmArray BCID Panel, and for species determination of some Staphylococci, Enterococci, Streptococci, and Enterobacteriaceae that are not specifically identified by the FilmArray BCID Panel assays.
Product codes
PEN, OOI, PAM
Device Description
The FilmArray Blood Culture Identification (BCID) Panel is a multiplex nucleic acid test designed to be used with a FilmArray system. The FilmArray BCID pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR with DNA melt analysis. The FilmArray Blood Culture Identification (BCID) Panel simultaneously tests a single positive blood culture sample to provide results for 24 different organisms and organism groups that cause bloodstream infections and three genetic markers that are known to confer antimicrobial resistance (see Table 1).
A test is initiated by loading Hydration Solution and a positive blood culture sample mixed with the provided Sample Buffer into the FilmArray BCID pouch. 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 software guides the user though the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.
The 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 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 FilmArray pouch using mechanical lysis and 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 PCR reaction which includes all primers of the outer primer sets, 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 21th stage PCR, or nested PCR, is performed in singleplex fashion in each well of the array. At the conclusion of the 21th 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 PCR reactions and software interprets the data.
The 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
Yes
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
Prescription Use (Part 21 CFR 801 Subpart D)
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
Clinical Performance Test Set:
- Sample Size: 100 specimens selected such that each analyte (and antibiotic resistance marker) was represented 3-5 times. 102 runs were attempted for the current system, and 202 for the modified system.
- Data Source: Specimens previously obtained during the FilmArray BCID prospective clinical evaluation and seeded blood cultures (remnant from the prospective BCID clinical study) for rare BCID analytes.
- Annotation Protocol: Not explicitly stated, but results were compared between current and modified systems using different loading tools.
Low Analyte Test Set:
- Sample Size: Not explicitly stated as a number of specimens, but involved a dilution series with concentrations of 1x, 0.1x, 0.01x, and 0.001x, with 5 replicates per test level.
- Data Source: Samples containing a mix of BCID analytes at various concentrations.
- Annotation Protocol: Not explicitly stated, but detection of each analyte at all concentrations was compared between current and modified FilmArray systems. Tm values were also compared.
Reproducibility Test Set:
- Sample Size: Contrived blood culture samples. Each analyte was evaluated at two different concentrations (Negative and Positive). For each sample, 90 data points were collected per loading procedure (5 different days x 3 testing sites x 6 runs per day = 90).
- Data Source: Contrived blood culture samples spiked with various concentrations of six different BCID organisms (some containing antibiotic resistance genes).
- Annotation Protocol: Multicenter study performed at three test sites. A range of potential variation introduced by ten different operators, three different pouch lots, and 14 different FilmArray 2.0 instruments per loading procedure on three different systems.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Study:
- Study Type: Clinical Performance Comparison.
- Sample Size: 100 specimens (each analyte represented 3-5 times) for comparisons between current and modified FilmArray systems and different loading tools.
- AUC: Not provided.
- MRMC: Not provided.
- Standalone Performance: Not applicable as it's a comparative study.
- Key Results: 100% concordance observed for most analytes across all comparisons. Occasional discrepant results were attributed to analyte levels well below what is typically seen in positive blood culture. Overall PPA for all three comparisons was 99.1% or greater, with the lower bound of the two-sided 95% CI at 95.3% or greater. Overall NPA for all three comparisons was 99.9% or greater with the lower bound of the two-sided 95% CI at 99.7% or greater.
Selected Analytic Studies - Low Analyte:
- Study Type: Analytical Study (Dilution Series).
- Sample Size: Multiple replicates (5) across 4 concentration levels for various organisms.
- AUC: Not provided.
- MRMC: Not provided.
- Standalone Performance: Not applicable as it's a comparative study.
- Key Results: Detection of each analyte at all concentrations was found to be comparable between the current and modified FilmArray systems using either syringe or injection vial pouch loading procedures. Mean Tm values for all FilmArray BCID assays on the modified configurations were within ±0.5℃ compared to the same samples tested on the current configuration.
Reproducibility Study:
- Study Type: Multicenter Reproducibility Study.
- Sample Size: A panel of contrived blood culture samples, each spiked with various concentrations (Positive and Negative) of six different BCID organisms. 90 data points per sample per loading procedure across multiple sites, operators, pouch lots, and instruments.
- AUC: Not provided.
- MRMC: Not provided.
- Standalone Performance: Not applicable as it's a reproducibility study.
- Key Results: The test results obtained for the BCID Panel on the multi-instrument FilmArray 2.0 systems following the syringe and injection vial loading procedures were highly reproducible and consistent with data collected on the current, single-instrument FilmArray. Most analytes showed 100% agreement with expected results across all sites/systems and loading procedures, with lower bounds of 95% CI generally above 96%. A few instances of slightly lower agreement (e.g., Enterococcus (98.9%), Candida krusei (97.8%), Candida parapsilosis (99.4%), vanA/B (98.9%), mecA (98.9%)) were observed for the syringe loading procedure, but Injection Vial loading procedure showed 100% agreement for these. Tm reproducibility was also evaluated, showing consistent mean Tm values and standard deviations across sites and loading procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Performance:
- Overall PPA (Positive Percent Agreement): 99.1% or greater (95% CI: 95.3% or greater)
- Overall NPA (Negative Percent Agreement): 99.9% or greater (95% CI: 99.7% or greater)
Reproducibility:
- Percent (%) agreement with the expected result for various analytes and conditions (positive/negative, by site/system, and overall). Ranges from 97.8% to 100% with associated 95% Confidence Intervals.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
(a)
Identification. A multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood cultures that test positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences for microorganism identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when used in conjunction with other clinical and laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.(b)
Classification. Class II (special controls). The special control for this device is FDA's guideline document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures.” For availability of the guideline document, see § 866.1(e).
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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 OF REGULATED PRODUCTS 390 WAKARA WAY SALT LAKE CITY UT 84108
January 30, 2015
Re: K143171
Trade/Device Name: FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 Regulation Number: 21 CFR 866.3365 Regulation Name: Multiplex nucleic acid assay for identification of microorganisms Regulatory Class: II Product Code: PEN, OOI, PAM Dated: October 31, 2014 Received: November 4, 2014
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Uwe Scherf - S for
Sally Hojvat, 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) K143171
Device Name
FilmArray Blood Culture Identifcation (BCID) Panel
Indications for Use (Describe)
The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray BCID Panel is capable of simultaneous detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants of antimicrobial resistance. The BCID assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system that demonstrate the presence of organisms as determined by Gram stain.
The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using the FilmArray BCID Panel: Enterococci, Listeria monocytogenes, Staphylococci (including specific differentiation of Staphylococcus aureus), Streptococci (with specific differentiation of Streptococcus pneumoniae, and Streptococcus pyogenes), Acinetobacter baumannii, Enterobacteriaceae (including specific differentiation of the Enterchacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and Serratia marcescens), Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Candida glabrata, Candida krusei, Candida parapsilosis, and Candida tropicalis.
The FilmArray BCID Panel also contains assays for the detection of genetic determinants of resistance to methicillin (mecA), vancomycin (vanA and vanB), and carbapenems (blaKPC) to aid in the identification of potentially antimicrobial resistant organisms in positive blood culture samples. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, and carbapenens exist.
FilmArray BCID is indicated as an aid in the diagnosis of specific agents of bacteremia and results should be used in conjunction with other clinical and laboratory findings. Positive FilmArray results do not rule out co-infection with organisms not included in the FilmArray BCID is not intended to monitor treatment for bacteremia or fungemia.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not detected by the FilmArray BCID Panel, and for species determination of some Staphylococi, Enterococci, Streptococci, and Enterobacteriaceae that are not specifically identified by the FilmArray BCID Panel assays.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary BioFire Diagnostics, LLC
FilmArray Blood Culture Identification (BCID) Panel for use with FilmArray 2.0
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 USA
Telephone: 801-736-6354 Facsimile: 801-588-0507
Contact: Kristen Kanack, ext. 330
Date Submitted: October 31, 2014
Device Name and Classification:
Trade Name: FilmArray Blood Culture Identification (BCID) Panel
Regulation Number: 21 CFR 866.3365
Classification Name: Multiplex devices that use DNA hybridization to detect bacteria and their resistance markers
Predicate Device:
K130914 - FilmArray BCID Panel
Intended Use:
The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray BCID Panel is capable of simultaneous detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants of antimicrobial resistance. The BCID assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system that demonstrate the presence of organisms as determined by Gram stain.
The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using the FilmArray BCID Panel: Enterococci, Listeria monocytogenes, Staphylococci (including specific differentiation of Staphylococcus aureus), Streptococci (with specific differentiation of
5
Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes), Acinetobacter baumannii, Enterobacteriaceae (including specific differentiation of the Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and Serratia marcescens), Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, and Candida tropicalis.
The FilmArray BCID Panel also contains assays for the detection of genetic determinants of resistance to methicillin (mecA), vancomycin (vanA and vanB), and carbapenems (blakpr) to aid in the identification of potentially antimicrobial resistant organisms in positive blood culture samples. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, and carbapenems exist.
FilmArray BCID is indicated as an aid in the diagnosis of specific agents of bacteremia and fungemia and results should be used in conjunction with other clinical and laboratory findings. Positive FilmArray results do not rule out co-infection with organisms not included in the FilmArray BCID Panel. FilmArray BCID is not intended to monitor treatment for bacteremia or fungemia.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not detected by the FilmArray BCID Panel, and for species determination of some Staphylococci, Enterococci, Streptococci, and Enterobacteriaceae that are not specifically identified by the FilmArray BCID Panel assays.
Device Description:
The FilmArray Blood Culture Identification (BCID) Panel is a multiplex nucleic acid test designed to be used with a FilmArray system. The FilmArray BCID pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR with DNA melt analysis. The FilmArray Blood Culture Identification (BCID) Panel simultaneously tests a single positive blood culture sample to provide results for 24 different organisms and organism groups that cause bloodstream infections and three genetic markers that are known to confer antimicrobial resistance (see Table 1).
| Gram-Positive Bacteria | Gram-Negative Bacteria | Yeast |
|---|---|---|
| Enterococcus | Acinetobacter baumannii | Candida albicans |
| Listeria monocytogenes | Enterobacteriaceae | Candida glabrata |
| Staphylococcus | Enterobacter cloacae complex | Candida krusei |
| Staphylococcus aureus | Escherichia coli | Candida parapsilosis |
| Streptococcus | Klebsiella oxytoca | Candida tropicalis |
| Streptococcus agalactiae | Klebsiella pneumoniae | Antimicrobial resistance genes |
| Streptococcus pneumoniae | Proteus | mecA - methicillin resistance |
| Streptococcus pyogenes | Serratia marcescens | vanA/B - vancomycin resistance |
| Haemophilus influenzae | blaKPC - carbapenem resistance |
| Table 1. FilmArray BCID Panel Test Results. | |||
|---|---|---|---|
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| Gram-Positive Bacteria | Gram-Negative Bacteria | Yeast |
|---|---|---|
| Neisseria meningitidis (encapsulated) | ||
| Pseudomonas aeruginosa |
A test is initiated by loading Hydration Solution and a positive blood culture sample mixed with the provided Sample Buffer into the FilmArray BCID pouch. 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 software guides the user though the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.
The 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 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 FilmArray pouch using mechanical lysis and 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 PCR reaction which includes all primers of the outer primer sets, 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 singleplex fashion in each well of the array. At the conclusion of the 21th 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 PCR reactions and software interprets the data.
The 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.
Substantial Equivalence:
The FilmArray BCID Panel for use with the FilmArray 2.0 is substantially equivalent to the FilmArray BCID Panel (K130914) for use with the FilmArray, which was cleared on June 21, 2013 and determined to be a Class II device.
The following table compares the FilmArray BCID Panel for use with the FilmArray 2.0to the previously cleared FilmArray BCID Panel (K130914). The table outlines the similarities and differences for the BCID Panel tested on the two devices.
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| Element | Predicate:
BCID Panel - FilmArray
(K130914) | New Device:
BCID Panel FilmArray 2.0 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Organisms Detected | Enterococci, Listeria monocytogenes,
Staphylococci (including specific
differentiation of Staphylococcus aureus),
Streptococci (with specific differentiation of
Streptococcus agalactiae, Streptococcus
pneumoniae, and Streptococcus pyogenes),
Acinetobacter baumannii, Enterobacteriaceae
(including specific differentiation of the
Enterobacter cloacae complex, Escherichia
coli, Klebsiella oxytoca, Klebsiella
pneumoniae, Proteus, and Serratia
marcescens), Haemophilus influenzae,
Neisseria meningitidis (encapsulated),
Pseudomonas aeruginosa, Candida albicans,
Candida glabrata, Candida krusei, Candida
parapsilosis, Candida tropicalis, and
resistance markers mecA, vanA, vanB, and
blaKPC (KPC) | Same |
| Analyte | RNA/DNA | Same |
| Specimen Types | Positive blood culture samples containing
gram-positive or gram-negative bacteria
and/or yeast. | Same |
| Technological
Principles | Nested multiplex RT-PCR followed by high
resolution melting analysis to confirm identity
of amplified product. | Same |
| Instrumentation | FilmArray | FilmArray or FilmArray 2.0 |
| 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 | Syringe-based loading procedure | Syringe-based loading procedure
or FilmArray Injection Vial-based
loading procedure |
| Sample Preparation
Method | Sample processing is automated in the
FilmArray BCID pouch. | Same |
| 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 |
Table 2. Comparison of the BCID Panel on FilmArray 2.0 (New) to the BCID Panel on FilmArray (Predicate).
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Summary of Performance Data
Clinical Performance
The original FilmArray BCID Panel was developed for use with the current, single instrument FilmArray system. A clinical study was conducted to compare the performance observed when testing clinical specimens using the FilmArray BCID in its current configuration on the current system to results obtained when testing with the modified system using the current loading tools (platform comparison) as well as results on the modified platform when syringes or FilmArray Injection Vial (FAIV) loading tools are used (loading tools comparison). Data obtained with the current system/tools were also compared to the modified system with FAIVs (multifactor comparison).
Specimens previously obtained during the FilmArray BCID prospective clinical evaluation comprised the base of the specimen set used for testing. Seeded blood cultures (remnant from the prospective BCID clinical study) were used for rare BCID analytes. A total of 100 specimens were selected such that each analyte (and antibiotic resistance marker) was represented 3-5 times.
System performance for testing these 102 specimens on each platform was calculated. For the current system, a total of 102 runs were attempted, 100 of which were completed (98.8%; 100/102). There were two run failures for software errors (2.0%). No control failures were observed.
For the modified system (paired with syringe and FAIV loading) a total of 202 runs were attempted, 200 of which were completed (99.0%; 200/202). There were two run failures for software errors (1.0%). No control failures were observed. All specimens were of sufficient volume that retesting was possible in order to obtain valid runs for all testing configurations.
As shown in Table3. 100% concordance was observed for most analytes across all comparisons. Occasional discrepant results were observed where an analyte was detected by one or two out of three pouches; in all cases this was attributed to analyte levels well below what is typically seen in positive blood culture. Overall PPA for all three comparisons was 99.1% or greater, with the
9
lower bound of the two-sided 95% confidence interval (95% CI) at 95.3% or greater. Overall NPA for all three comparisons was 99.9% or greater with the lower bound of the two-sided 95% CI at 99.7% or greater
10
Table 3. Analyte Detections across all systems and 1x vs Y' headers, Y is the denominator. The number of PC and SBC that comprised each analyte population are shown. Comparisons demonstrating performance less than 10% but are shaded in yellow. CS + S = Current System, Syringer, MS-S = Modified System, Syringe; MS+F = Modified System, FAIV
| | Specimen
Type | | | MS+S vs CS+S | | | | MS+F vs MS+S | | | | MS+F vs CS+S | | | |
|------------------------------|------------------|-----|-------|--------------|--------|-------|-------|--------------|-------|------|-------|--------------|--------|-------|--|
| Analyte | PB
C | SBC | PPA | % | NPA | % | PPA | % | NPA | % | PPA | % | NPA | % | |
| Gram-Positive Bacteria | | | | | | | | | | | | | | | |
| Enterococcus | 6 | 1 | 6/6 | 100% | 93/94a | 98.9% | 6/7a | 85.7% | 93/93 | 100% | 6/6 | 100% | 94/94 | 100% | |
| Listeria monocytogenes | 0 | 4 | 4/4 | 100% | 96/96 | 100% | 4/4 | 100% | 96/96 | 100% | 4/4 | 100% | 96/96 | 100% | |
| Staphylococcus | 11 | 0 | 10/10 | 100% | 89/90b | 98.9% | 11/11 | 100% | 89/89 | 100% | 10/10 | 100% | 89/90b | 98.9% | |
| Staphylococcus aureus | 5 | 0 | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | |
| Streptococcus | 15 | 0 | 15/15 | 100% | 85/85 | 100% | 15/15 | 100% | 85/85 | 100% | 15/15 | 100% | 85/85 | 100% | |
| Streptococcus agalactiae | 3 | 0 | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | |
| Streptococcus pneumoniae | 3 | 0 | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | |
| Streptococcus pyogenes | 3 | 0 | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | |
| Gram-Negative Bacteria | | | | | | | | | | | | | | | |
| Acinetobacter baumannii | 5 | 0 | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | |
| Enterobacteriaceae | 22 | 1 | 23/23 | 100% | 77/77 | 100% | 23/23 | 100% | 77/77 | 100% | 23/23 | 100% | 77/77 | 100% | |
| Enterobacter cloacae complex | 3 | 0 | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | |
| Escherichia coli | 3 | 0 | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | |
| Klebsiella oxytoca | 3 | 0 | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | |
| Klebsiella pneumoniae | 3 | 1 | 4/4 | 100% | 96/96 | 100% | 4/4 | 100% | 96/96 | 100% | 4/4 | 100% | 96/96 | 100% | |
| Proteus | 3 | 0 | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | |
| Serratia marcescens | 3 | 0 | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | 3/3 | 100% | 97/97 | 100% | |
| Haemophilus influenzae | 3 | 1 | 4/4 | 100% | 96/96 | 100% | 4/4 | 100% | 96/96 | 100% | 4/4 | 100% | 96/96 | 100% | |
| Neisseria meningitidis | 1 | 3 | 4/4 | 100% | 96/96 | 100% | 4/4 | 100% | 96/96 | 100% | 4/4 | 100% | 96/96 | 100% | |
| Pseudomonas aeruginosa | 4 | 0 | 4/4 | 100% | 96/96 | 100% | 4/4 | 100% | 96/96 | 100% | 4/4 | 100% | 96/96 | 100% | |
| Yeast | | | | | | | | | | | | | | | |
| Candida albicans | 5 | 0 | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | |
| Candida glabrata | 5 | 0 | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | |
| Candida krusei | 3 | 2 | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | |
| Candida parapsilosis | 5 | 0 | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | |
BioFire Diagnostics, LLC 510(k)
Multi-instrument FilmArray Blood Culture Identification Panel
11
| | | Specimen
Type | MS+S vs CS+S | | | MS+F vs MS+S | | | MS+F vs CS+S | | | | | | | | | |
|--------------------------------|---------|------------------|--------------|------|-----------|--------------|---------|-----------|--------------|------|-----------|------|-----------|-----------|--|--|-----------|--|
| Analyte | PB
C | SBC | PPA | % | NPA | % | PPA | % | NPA | % | PPA | % | NPA | % | | | | |
| Candida tropicalis | 3 | 2 | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | | | | |
| Antimicrobial Resistance Genes | | | | | | | | | | | | | | | | | | |
| mecA | 6 | 0 | 5/5 | 100% | 5/5c | 100% | 6/6 | 100% | 5/5 | 100% | 5/5c | 100% | 5/5c | 100% | | | | |
| vanA/B | 2 | 1 | 3/3 | 100% | 3/3 | 100% | 3/3 | 100% | 3/3 | 100% | 3/3 | 100% | 3/3 | 100% | | | | |
| KPC | 3 | 1 | 4/4 | 100% | 28/28 | 100% | 4/4 | 100% | 28/28 | 100% | 4/4 | 100% | 28/28 | 100% | | | | |
| Overall agreement/ | | | 113/113 | 100% | 1885/1887 | 99.9% | 114/115 | 99.1% | 1885/1885 | 100% | 113/113 | 100% | 1886/1887 | 100% | | | | |
| 95% CI | | 96.8-100% | | | 99.7-100% | | | 95.3-100% | | | 99.8-100% | | | 96.8-100% | | | 99.7-100% | |
" Specimen 014111-BC-0043 was originally characterized as presidedly positive for Entercococcus when tested on the MS-S but was not when tested on the CS+S or the MS+F.
" Specimen 014111-BC-0006 was originally characterized as positive for S. capitis which was detected when tested on the MS+F but was not detected when tested on the CS+S. The BCID Panel is known to have reduced sensitivity for S. capitis as described in the package insert.
" Because Staphylococus was not detected in specifical in the CS+S as described in footnote "b", meet was not reported (i.e., was reported (i.e., was reported (i.e., was repo N/A) in this specimen and the specimen could not be recei in performance calculations for mech assay was positive in all 3 testing configurations.
12
Selected Analytic Studies
Low Analyte
A comparison of performance between the current FilmArray system (one instrument to one computer configuration) and the FilmArray 2.0 system (up to eight instruments to one computer) was performed for the FilmArray Blood Culture Identification (BCID) Panel. Testing performed on the current system using the current syringe-based pouch loading procedure was compared to data collected on the modified system with both the syringe-based pouch loading procedure and a modified, injection vial-based pouch loading procedure.
Testing consisted of a dilution series of samples containing a mix of BCID analytes. The concentration of analyte in the samples started at the level known to be present in positive blood cultures (1×), followed by 10-fold serial dilutions (0.1× - 0.001× test levels).
In the titration series testing, detection of each analyte at all concentrations was found to be comparable between the current and modified FilmArray systems using either the syringe or injection vial pouch loading procedures (Table 4).
Table 4. Results of the Titration Testing for the Blood Culture Identification (BCID) Panel on Current and Modified FilmArray Systems with Syringe and/or Injection Vial Pouch Loading Procedures At each test level, if the number of detected results on the modified system (syringe or injection vial) was the same as for the current system (syringe) the results are listed as 'Same'.
| Organism | FilmArray BCID
Test Result | Test Level | Current System
(Syringe) | Modified System
(Syringe) | Modified System
(Injection Vial) |
|------------------------------------------------------|---------------------------------|------------|-------------------------------|-------------------------------|-------------------------------------|
| GRAM-POSITIVE BACTERIA | | | | | |
| Enterococcus faecalis (vanB)
JMI 368 | Enterococcus | 1× | 5/5 (100%) | Same | Same |
| | Enterococcus | 0.1× | 5/5 (100%) | | |
| | Enterococcus | 0.01× | 5/5 (100%) | | |
| | Enterococcus | 0.001× | 4/5 (80%) | | |
| Enterococcus faecalis (vanB)
JMI 368 | vanA/B | 1× | 5/5 (100%) | 3/5 (60%) | 3/5 (60%) |
| | vanA/B | 0.1× | 5/5 (100%) | Same | Same |
| | vanA/B | 0.01× | 5/5 (100%) | | |
| | vanA/B | 0.001× | 4/5 (80%) | | |
| Enterococcus faecium (vanA)
JMI 475 | Enterococcus | 1× | 5/5 (100%) | 3/5 (60%) | 3/5 (60%) |
| | Enterococcus | 0.1× | 5/5 (100%) | Same | Same |
| | Enterococcus | 0.01× | 5/5 (100%) | | |
| | Enterococcus | 0.001× | 1/5 (20%) | | |
| Enterococcus faecium (vanA)
JMI 475 | vanA/B | 1× | 5/5 (100%) | 5/5 (100%) | 2/5 (40%) |
| | vanA/B | 0.1× | 5/5 (100%) | Same | Same |
| | vanA/B | 0.01× | 5/5 (100%) | | |
| | vanA/B | 0.001× | 1/5 (20%) | | |
| Listeria monocytogenes
ATCC 43256 | Listeria monocytogenes | 1× | 5/5 (100%) | 5/5 (100%) | 2/5 (40%) |
| | Listeria monocytogenes | 0.1× | 5/5 (100%) | Same | Same |
| | Listeria monocytogenes | 0.01× | 5/5 (100%) | | |
| | Listeria monocytogenes | 0.001× | 5/5 (100%) | | |
| Staphylococcus aureus (mecA)
ATCC BAA-1747 | Staphylococcus | 1× | 5/5 (100%) | Same | Same |
| | Staphylococcus | 0.1× | 5/5 (100%) | | |
| | Staphylococcus | 0.01× | 5/5 (100%) | | |
| | Staphylococcus | 0.001× | 4/5 (80%) | | |
| Staphylococcus aureus (mecA)
ATCC BAA-1747 | mec A | 1× | 5/5 (100%) | 5/5 (100%) | 3/5 (60%) |
| | mec A | 0.1× | 5/5 (100%) | Same | Same |
| | mec A | 0.01× | 5/5 (100%) | | |
| | mec A | 0.001× | 5/5 (100%) | | |
| Organism | FilmArray BCID
Test Result | Test Level | Current System
(Syringe) | Modified System
(Syringe) | Modified System
(Injection Vial) |
| Staphylococcus
epidermidis
ATCC 12228 | Staphylococcus | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | | 0.001× | 4/5 (80%) | | |
| Streptococcus
mitis
ATCC 15914 | Streptococcus | 1× | 5/5 (100%) | Same | 4/5 (80%) |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 4/5 (80%) | | 3/5 (60%) |
| | | 0.001× | 0/5 (0%) | | 0/5 (0%) |
| Streptococcus
agalactiae
ATCC 13813 | Streptococcus | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | | 0.001× | 5/5 (100%) | | |
| Streptococcus
pneumoniae a
ATCC BAA-255 | Streptococcus | 1× a | 5/5 (100%) | Same | Same |
| | | 0.1× a | 5/5 (100%) | | |
| | | 0.01× a | 5/5 (100%) | | |
| | Streptococcus
pneumoniae | 0.001× a | 5/5 (100%) | | |
| Streptococcus
pyogenes
ATCC 19615 | Streptococcus | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | Streptococcus pyogenes | 0.001× | 5/5 (100%) | | |
| GRAM-NEGATIVE BACTERIA | | | | | |
| Acinetobacter
baumannii
ATCC 9955 | Acinetobacter
baumannii | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | | 0.001× | 5/5 (100%) | | |
| Enterobacter
cloacae
ATCC 13047 | Enterobacteriaceae | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | Enterobacter cloacae
complex | 0.001× | 3/5 (60%) | | |
| Escherichia coli
ATCC 43888 | Enterobacteriaceae | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | Escherichia coli | 0.001× | 4/5 (80%) | | 0/5 (0%) |
| Klebsiella oxytoca | Enterobacteriaceae | 1× | 5/5 (100%) | Same | Same |
| Organism | FilmArray BCID Test Result | Test Level | Current System (Syringe) | # Detected/Total (% Detected) | |
| | | | | Modified System (Syringe) | Modified System (Injection Vial) |
| ATCC 13182 | Klebsiella oxytoca | 0.1× | 5/5 (100%) | Same | Same |
| | | 0.01× | 5/5 (100%) | | |
| | | 0.001× | 5/5 (100%) | | |
| | Enterobacteriaceae | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| Klebsiella pneumoniae (KPC) JMI 766 | Klebsiella pneumoniae | 0.001× | 5/5 (100%) | Same | Same |
| | | 1× | 5/5 (100%) | | |
| | | 0.1× | 5/5 (100%) | | |
| | KPC | 0.01× | 5/5 (100%) | Same | Same |
| | | 0.001× | 5/5 (100%) | | |
| | | 1× | 5/5 (100%) | | |
| Proteus mirabilis
ATCC 29906 | Enterobacteriaceae | 0.1× | 5/5 (100%) | Same | Same |
| | | 0.01× | 5/5 (100%) | | |
| | Proteus | 0.001× | 4/5 (80%) | 4/5 (80%) | 1/5 (20%) |
| | | 1× | 5/5 (100%) | Same | Same |
| | Enterobacteriaceae | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | Same | Same |
| Serratia marcescens a
ATCC 27137 | | 0.001× | 5/5 (100%) | | |
| | Serratia marcescens | 1× a | 5/5 (100%) | | |
| | | 0.1× a | 5/5 (100%) | | |
| | | 0.01× a | 5/5 (100%) | Same | Same |
| Haemophilus influenzae a
ATCC 10211 | Haemophilus influenzae | 0.001× a | 5/5 (100%) | | |
| | | 1× a | 5/5 (100%) | | |
| | | 0.1× a | 5/5 (100%) | | |
| | | 0.01× a | 5/5 (100%) | Same | Same |
| Neisseria meningitidis b
ATCC 43744 | Neisseria meningitidis | 0.001× a | 5/5 (100%) | | |
| | | 1× b | 5/5 (100%) | Same | Same |
| | | 0.1× b | 5/5 (100%) | | |
| | | 0.01× b | 5/5 (100%) | | |
| Pseudomonas aeruginosa
ATCC 27853 | Pseudomonas aeruginosa | 0.001× b | 5/5 (100%) | | |
| | | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | | 0.001× | 5/5 (100%) | | |
| YEAST | | | | | |
| Candida albicans
ATCC 10231 | Candida albicans | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 4/5 (80%) | 4/5 (80%) | 3/5 (60%) |
| | | 0.001× | 1/5 (20%) | 1/5 (20%) | 2/5 (40%) |
| Candida glabrata
ATCC 15545 | Candida glabrata | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| Organism | FilmArray BCID
Test Result | Test Level | # Detected/Total (% Detected) | | |
| | | | Current System
(Syringe) | Modified System
(Syringe) | Modified System
(Injection Vial) |
| Candida krusei
ATCC 90878 | Candida krusei | 0.001× | 4/5 (80%) | 5/5 (100%) | 4/5 (80%) |
| | | 1× | 5/5 (100%) | Same | |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | 0.001× | 5/5 (100%) | | | |
| Candida parapsilosis
ATCC 90875 | Candida parapsilosis | 1× | 5/5 (100%) | Same | |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | | 0.001× | 4/5 (80%) | 5/5 (100%) | 5/5 (100%) |
| Candida tropicalis
ATCC 66029 | Candida tropicalis | 1× | 5/5 (100%) | Same | |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | | 0.001× | 5/5 (100%) | | |
13
BioFire Diagnostics, LLC 510(k)
Multi-instrument FilmArray Blood Culture Identification Panel
Multi-instrument FilmArray Blood Culture Identification Panel
14
BioFire Diagnostics, LLC 510(k)
Multi-instrument FilmArray Blood Culture Identification Panel
15
4 The starting 1× concentration is equivalent to half (0.5×) the concentration in a positive blood culture and the same adjustment applies to all dilutions (0.05×, 0.005×, and 0.0005× relative to blood culture level). b The starting 1× concentration is equivalent to one-tenth (0.1×) the concentration in a positive blood culture and the same adjustment applies to all dilutions (0.01×, 0.001×, and 0.0001× relative to blood culture level).
Tm values from the titration series were compared to assess whether Tm data are equivalent between the current and modified FilmArray systems, the syringe and injection vial pouch loading procedures, and between the current and modified system/loading combined. Normal Tm variation of the current FilmArray configuration is ±0.5℃ and it was observed that mean Tm values for all FilmArray BCID assays on the modified configurations were ± 0.5℃ or less compared to the same samples tested on the current configuration (ΔTm System, ΔTm Loading, and △Tm Combined in Table 5).
Table 5. Comparison of Mean Tm Values for FilmArray BCID Panel Analytes on the Current and Modified Systems with Syringe or Injection Vial Pouch Loading Procedures
| Organism | Assay | FilmArray System
(Loading Procedure) | Mean
Tma | △ Mean Tm
System | △Tm
Loading | △Tm
Combined |
|---------------------------------|------------------|-----------------------------------------|-------------|---------------------|----------------|-----------------|
| Enterococcus faecium
(vanA) | Enterococcus | Current (Syringe) | 82.6 | 0.0 | | 0.0 |
| | | Modified (Syringe) | 82.6 | | 0.0 | |
| | | Modified (Injection Vial) | 82.6 | | | |
| | vanA/B | Current (Syringe) | 85.6 | 0.2 | | 0.0 |
| | | Modified (Syringe) | 85.4 | | -0.2 | |
| | | Modified (Injection Vial) | 85.6 | | | |
| Enterococcus faecalis
(vanB) | Enterococcus | Current (Syringe) | 82.2 | 0.1 | | -0.1 |
| | | Modified (Syringe) | 82.1 | | -0.2 | |
| | | Modified (Injection Vial) | 82.3 | | | |
| | vanA/B | Current (Syringe) | 81.6 | 0.1 | | 0.0 |
| | | Modified (Syringe) | 81.5 | | -0.1 | |
| | | Modified (Injection Vial) | 81.6 | | | |
| | vanA/B | Current (Syringe) | 86.1 | 0.2 | | 0.1 |
| | | Modified (Syringe) | 85.9 | | -0.1 | |
| | | Modified (Injection Vial) | 86.0 | | | |
| Listeria monocytogenes | Lmonocytogenes | Current (Syringe) | 80.2 | 0.2 | | 0.1 |
| | | Modified (Syringe) | 80.0 | | -0.1 | |
| | | Modified (Injection Vial) | 80.1 | | | |
| Staphylococcus aureus
(mecA) | Saureus | Current (Syringe) | 77.0 | 0.1 | | 0.1 |
| | | Modified (Syringe) | 76.9 | | 0.0 | |
| | | Modified (Injection Vial) | 76.9 | | | |
| Organism | Assay | FilmArray System
(Loading Procedure) | Mean
Tmᵃ | ΔTm
System | ΔTm
Loading | ΔTm
Combined |
| | mecA | Current (Syringe) | 73.5 | 0.1 | | 0.0 |
| | | Modified (Syringe) | 73.4 | | -0.1 | |
| | | Modified (Injection Vial) | 73.5 | | | |
| Streptococcus mitis | Streptococcus | Current (Syringe) | 83.7 | 0.2 | | 0.1 |
| | | Modified (Syringe) | 83.5 | | -0.1 | |
| | | Modified (Injection Vial) | 83.6 | | | |
| Staphylococcus
epidermidis | Staphylococcus 1 | Current (Syringe) | 79.3 | 0.1 | | -0.1 |
| | | Modified (Syringe) | 79.2 | | -0.2 | |
| | | Modified (Injection Vial) | 79.4 | | | |
| | Staphylococcus 2 | Current (Syringe) | 79.0 | 0.2 | | 0.0 |
| | | Modified (Syringe) | 78.8 | | -0.2 | |
| | | Modified (Injection Vial) | 79.0 | | | |
| Streptococcus
agalactiae | Streptococcus | Current (Syringe) | 81.5 | 0.0 | | 0.0 |
| | | Modified (Syringe) | 81.5 | | 0.0 | |
| | | Modified (Injection Vial) | 81.5 | | | |
| | Sagalactiae | Current (Syringe) | 80.8 | -0.1 | | 0.1 |
| | | Modified (Syringe) | 80.9 | | 0.2 | |
| | | Modified (Injection Vial) | 80.7 | | | |
| | Spneumoniae | Current (Syringe) | 82.9 | 0.1 | | 0.1 |
| | | Modified (Syringe) | 82.8 | | 0.0 | |
| | | Modified (Injection Vial) | 82.8 | | | |
| Streptococcus
pyogenes | Streptococcus | Current (Syringe) | 81.3 | 0.2 | | 0.0 |
| | | Modified (Syringe) | 81.1 | | -0.2 | |
| | | Modified (Injection Vial) | 81.3 | | | |
| | Spyogenes | Current (Syringe) | 78.9 | 0.2 | | 0.0 |
| | | Modified (Syringe) | 78.7 | | -0.2 | |
| | | Modified (Injection Vial) | 78.9 | | | |
| | Streptococcus | Current (Syringe) | 82.1 | 0.2 | | 0.1 |
| | | Modified (Syringe) | 81.9 | | -0.1 | |
| | | Modified (Injection Vial) | 82.0 | | | |
| Acinetobacter
baumannii | Abaumannii | Current (Syringe) | 80.3 | 0.1 | | -0.1 |
| | | Modified (Syringe) | 80.2 | | -0.2 | |
| | | Modified (Injection Vial) | 80.4 | | | |
| Enterobacter
cloacae | Enteric | Current (Syringe) | 87.6 | 0.2 | | 0.0 |
| | | Modified (Syringe) | 87.4 | | -0.2 | |
| | | Modified (Injection Vial) | 87.6 | | | |
| | Ecloacae | Current (Syringe) | 83.8 | 0.2 | | 0.0 |
| | | Modified (Syringe) | 83.6 | | -0.2 | |
| | | Modified (Injection Vial) | 83.8 | | | |
| | Enteric | Current (Syringe) | 87.9 | 0.2 | | 0.0 |
| | | Modified (Syringe) | 87.7 | | -0.2 | |
| | | Modified (Injection Vial) | 87.9 | | | |
| Escherichia coli | Ecoli | Current (Syringe) | 87.2 | 0.2 | | 0.1 |
| | | Modified (Syringe) | 87.0 | | -0.1 | |
| | | Modified (Injection Vial) | 87.1 | | | |
| | Enteric | Current (Syringe) | 88.6 | 0.0 | | 0.1 |
| | | Modified (Syringe) | 88.6 | | 0.1 | |
| | | Modified (Injection Vial) | 88.5 | | | |
| | | Current (Syringe) | 87.7 | 0.0 | | 0.2 |
| | | Modified (Syringe) | 87.7 | | 0.2 | |
| | | Modified (Injection Vial) | 87.5 | | | |
| Klebsiella pneumoniae
(KPC) | Kpneumoniae | Current (Syringe) | 86.0 | -0.1 | | 0.1 |
| | | Modified (Syringe) | 86.1 | | 0.2 | |
| | | Modified (Injection Vial) | 85.9 | | | |
| | KPC | Current (Syringe) | 87.7 | 0.0 | | 0.2 |
| | | Modified (Syringe) | 87.7 | | 0.2 | |
| | | Modified (Injection Vial) | 87.5 | | | |
| | | Current (Syringe) | 86.0 | -0.1 | | 0.1 |
| | | Modified (Syringe) | 86.1 | | 0.2 | |
| | | Modified (Injection Vial) | 85.9 | | | |
| Organism | Assay | FilmArray System
(Loading Procedure) | Mean
Tma | Δ Mean Tm | | |
| | | | | ΔTm
System | ΔTm
Loading | ΔTm
Combined |
| Klebsiella oxytoca | Enteric | Current (Syringe) | 87.3 | 0.2 | | |
| | | Modified (Syringe) | 87.1 | | -0.2 | 0.0 |
| | | Modified (Injection Vial) | 87.3 | | | |
| | Koxytoca | Current (Syringe) | 83.1 | 0.2 | | |
| | | Modified (Syringe) | 82.9 | | -0.2 | 0.0 |
| | | Modified (Injection Vial) | 83.1 | | | |
| Proteus mirabilis | Proteus | Current (Syringe) | 81.3 | 0.2 | | |
| | | Modified (Syringe) | 81.1 | | -0.1 | 0.1 |
| | | Modified (Injection Vial) | 81.2 | | | |
| Serratia marcescens | Smarcescens | Current (Syringe) | 85.7 | 0.1 | | |
| | | Modified (Syringe) | 85.6 | | -0.1 | 0.0 |
| | | Modified (Injection Vial) | 85.7 | | | |
| Haemophilus influenzae | Hinfluenzae 1 | Current (Syringe) | 77.6 | -0.1 | | |
| | | Modified (Syringe) | 77.7 | | 0.1 | 0.0 |
| | | Modified (Injection Vial) | 77.6 | | | |
| | Hinfluenzae 2 | Current (Syringe) | 80.2 | -0.1 | | |
| | | Modified (Syringe) | 80.3 | | 0.1 | 0.0 |
| | | Modified (Injection Vial) | 80.2 | | | |
| Neisseria meningitidis | Nmeningitidis | Current (Syringe) | 83.0 | 0.1 | | |
| | | Modified (Syringe) | 82.9 | | -0.1 | 0.0 |
| | | Modified (Injection Vial) | 83.0 | | | |
| Pseudomonas aeruginosa | Paeruginosa | Current (Syringe) | 87.9 | 0.1 | | |
| | | Modified (Syringe) | 87.8 | | 0.0 | 0.1 |
| | | Modified (Injection Vial) | 87.8 | | | |
| Candida albicans | Calbicans | Current (Syringe) | 79.7 | 0.1 | | |
| | | Modified (Syringe) | 79.6 | | -0.2 | -0.1 |
| | | Modified (Injection Vial) | 79.8 | | | |
| Candida glabrata | Cglabrata | Current (Syringe) | 75.2 | 0.0 | | |
| | | Modified (Syringe) | 75.2 | | -0.1 | -0.1 |
| | | Modified (Injection Vial) | 75.3 | | | |
| Candida krusei | Ckrusei | Current (Syringe) | 84.5 | 0.1 | | |
| | | Modified (Syringe) | 84.4 | | -0.1 | 0.0 |
| | | Modified (Injection Vial) | 84.5 | | | |
| Candida parapsilosis | Cparapsilosis | Current (Syringe) | 77.3 | 0.1 | | |
| | | Modified (Syringe) | 77.2 | | -0.1 | 0.0 |
| | | Modified (Injection Vial) | 77.3 | | | |
| Candida tropicalis | Ctropicalis | Current (Syringe) | 78.8 | 0.1 | | |
| | | Modified (Syringe) | 78.7 | | -0.1 | 0.0 |
| | | Modified (Injection Vial) | 78.8 | | | |
16
17
4 Mean Tm calculated from all replicates at all concentrations.
Reproducibility
A multicenter reproducibility study was performed to determine between-site/system and overall reproducibility of the FilmArray Blood Culture Identification (BCID) Panel on multi-instrument FilmArray 2.0 systems using the current (syringe) and modified (injection vial) pouch loading procedures.
Reproducibility testing occurred at three test sites using a panel of contrived blood culture samples, each spiked with various concentrations of six different BCID organisms (some
18
containing antibiotic resistance genes). Each analyte was evaluated at two different concentrations (Negative and Positive).
The study incorporated a range of potential variation introduced by ten different operators, three different pouch lots, and 14 different FilmArray 2.0 instruments per loading procedure on three different systems. A system consisted of at least three instruments connected to a single computer. Samples were stored frozen and tested on five different days at three testing sites (one system, A, B, or C per site) for 90 data points per sample, per loading procedure.
A summary of results (percent (%) agreement with the expected result) for each analyte (by site/system and overall) is provided in Table 6 alongside the overall % Agreement with Expected Results originally obtained on the single-instrument system.
19
| BCID Panel
Test Result | Organism
Tested | Test
Level | Expected
Test
Result | Multi-instrument
FilmArray 2.0 System
(Syringe)
Site/System | | | All
Sites/Systems
(95% CI) | Multi-instrument
FilmArray 2.0 System
(Injection Vial)
Site/System | | | All
Sites/Systems
(95% CI) | Single-instrument
FilmArray
Systemb
(Syringe)
All sites
(95% CI) | |
|------------------------------------|---------------------------------------------------------|---------------|----------------------------|----------------------------------------------------------------------|-------------------------------------------------------|----------------|----------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------|---------------------------------|-----------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------|
| Enterococcus | Enterococcus
faecalis
(vanB)
JMI 368 | Positive | Detected | 30/30
100% | 30/30
100% | 29/30
96.7% | 89/90
98.90%
(94.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 180/180
100%
(98.0%-100%) | |
| Enterococcus | Enterococcus
faecalis
(vanB)
JMI 368 | Negative | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 360/360
100%
(99.0%-100%) | |
| Listeria
monocytogenes | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 540/540
100%
(99.3%-100%) | |
| Staphylococcus | Staphylococcus
aureus
(mecA)
ATCC BAA-
1747 | Positive | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 90/90
100%
(96.0%-100%) | |
| | Staphylococcus
aureus
(mecA)
ATCC BAA-
1747 | Negative | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 449/450
98.8%
(98.8-100%) | |
| Staphylococcus
aureus | Staphylococcus
aureus
(mecA)
ATCC BAA-
1747 | Positive | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 90/90
100%
(96.0%-100%) | |
| | Staphylococcus
aureus
(mecA)
ATCC BAA-
1747 | Negative | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 450/450
100%
(99.2%-100%) | |
| Streptococcus | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 450/450
100%
(99.2%-100%) | |
| Streptococcus
agalactiae | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 540/540
100%
(99.3%-100%) | |
| Streptococcus
pneumoniae | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 540/540
100%
(99.3%-100%) | |
| Streptococcus | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 450/450
100%
(99.2%-100%) | |
| BCID Panel
Test Result | Organism
Tested | Test
Level | Expected
Test
Result | Multi-instrument
FilmArray 2.0 System
(Syringe) | | | | Multi-instrument
FilmArray 2.0 System
(Injection Vial) | | | | Single-instrument
FilmArray
Systemb
(Syringe) | |
| | | | | Site/System | | | All
Sites/Systems
(95% CI) | Site/System | | | All
Sites/Systems
(95% CI) | All sites
(95% CI) | |
| | | | | A | B | C | | A | B | C | | | |
| pyogenes | | | Detected | 100% | 100% | 100% | 100%
(98.0%-100%) | 100% | 100% | 100% | 100%
(98.0%-100%) | 100%
(99.2%-100%) | |
| Enterobacteriac
eae | Klebsiella
pneumoniae
(KPC)
JMI 7818 | Positive | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 180/180
100%
(98.0%-100%) | |
| | | Negative | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 360/360
100%
(99.0%-100%) | |
| Enterobacter
cloacae
complex | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 540/540
100%
(99.3%-100%) | |
| Escherichia coli | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 540/540
100%
(99.3%-100%) | |
| Klebsiella
oxytoca | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 540/540
100%
(99.3%-100%) | |
| | Klebsiella
pneumoniae | Positive | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 90/90
100%
(96.0%-100%) | |
| Klebsiella
pneumoniae | (KPC)
JMI 7818 | Negative | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 450/450
100%
(99.2%-100%) | |
| Proteus | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 450/450
100%
(99.2%-100%) | |
| Serratia
marcescens | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 450/450
100%
(99.2%-100%) | |
| Haemophilus
influenzae | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 539/540
99.8%
(99.0%-100%) | |
| Neisseria | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 540/540
100%
(99.3%-100%) | |
| | | | | % Agreement with Expected Resulta | | | | | % Agreement with Expected Resulta | | | | |
| BCID Panel
Test Result | Organism
Tested | Test
Level | Expected
Test
Result | | Multi-instrument
FilmArray 2.0 System
(Syringe) | | | | Multi-instrument
FilmArray 2.0 System
(Injection Vial) | | | | Single-instrument
FilmArray
Systemb
(Syringe) |
| | | | | | Site/System | | All
Sites/Systems
(95% CI) | | Site/System | | All
Sites/Systems
(95% CI) | All sites
(95% CI) | |
| | | | | A | B | C | | A | B | C | | | |
| meningitidis | | | Detected | 100% | 100% | 100% | 100%
(98.0%-100%) | 100% | 100% | 100% | 100%
(98.0%-100%) | 100%
(99.3%-100%) | |
| Pseudomonas
aeruginosa | Pseudomonas
aeruginosa
ATCC 27853 | Positive | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 90/90
100%
(96.0%-100%) | |
| | | Negative | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 450/450
100%
(99.2%-100%) | |
| Candida
albicans | Candida
albicans
ATCC 10231 | Positive | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 90/90
100%
(96.0%-100%) | |
| | | Negative | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 450/450
100%
(99.2%-100%) | |
| Candida
glabrata | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 450/450
100%
(99.2%-100%) | |
| Candida krusei | Candida krusei
ATCC 90878 | Positive | Detected | 29/30
96.7% | 30/30
100% | 29/30
96.7% | 88/90
97.80%
(92.2%-99.7%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 90/90
100%
(96.0%-100%) | |
| | | Negative | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 450/450
100%
(99.2%-100%) | |
| Candida
parapsilosis | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 59/60
98.3% | 60/60
100% | 60/60
100% | 179/180
99.4%
(96.9%-99.9%) | 539/540c
99.8%
(99.0%-100%) | |
| Candida
tropicalis | N/A | Negative | Not
Detected | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 60/60
100% | 60/60
100% | 60/60
100% | 180/180
100%
(98.0%-100%) | 450/450
100%
(99.2%-100%) | |
| van A/B | Enterococcus
faecalis
(vanB) | Positive | Detected | 30/30
100% | 30/30
100% | 29/30
96.7% | 89/90
98.90%
(94.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 180/180
100%
(98.0%-100%) | |
| | Organism
Tested | Test
Level | Expected
Test
Result | % Agreement with Expected Resulta | | | | | | | | | |
| BCID Panel
Test Result | | | | Multi-instrument
FilmArray 2.0 System
(Syringe) | | | | Multi-instrument
FilmArray 2.0 System
(Injection Vial) | | | | Single-instrument
FilmArray
Systemb
(Syringe) | |
| | | | | Site/System | | | All | Site/System | | | All | All sites | |
| | | | | A | B | C | Sites/Systems
(95% CI) | A | B | C | Sites/Systems
(95% CI) | (95% CI) | |
| | JMI 368 | Negative | N/A | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 360/360
100%
(99.0%-100%) | |
| mecA | Staphylococcus
aureus
(mecA)
ATCC BAA-
1747 | Positive | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 29/30
96.7% | 89/90
98.90%
(94%-100%) | 90/90
100%
(96.0%-100%) | |
| | | Negative | N/A | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 449/450c
99.8%
(98.8%-100%) | |
| KPC | Klebsiella
pneumoniae
(KPC)
JMI 7818 | Positive | Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 90/90
100%
(96.0%-100%) | |
| | | Negative | N/A | N/Ad | | | | | | 270/270
100%
(98.6%-100%) | | | |
| | | | Not
Detected | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 30/30
100% | 30/30
100% | 30/30
100% | 90/90
100%
(96.0%-100%) | 180/180
100%
(98.0%-100%) | |
Table 6. Reproducibility of the FilmArray BCD Panel Test Results on Multi-instrument FilmArray Systems
BioFire Diagnostics, LLC 510(k) Multi-instrument FilmArray Blood Culture Identification Panel
20
21
22
4 Performance calculations with lower than 100% agreement with expected results are indicated in bold font.
" Single-instrument FilmArray System (Syringe) data reproduced from SDY-007653, "Evaluation of Reproducibility for the FilmArray Blood Culture Identification (BCID) System.'
6 A single pouch run at Site B generated four false positive results: Staphylococus, mecA, Haemophilus influenzae, and Candida parapsilosis.
d KPC test result of Not Detected instead of N/A due to the presence of Pseudomonas aeruginosa in the sample.
23
The test results obtained for the BCID Panel on the multi-instrument FilmArray 2.0 systems following the syringe and injection vial loading procedures were highly reproducible and are consistent with the data collected on the current, single-instrument FilmArray in the original BCID Panel Reproducibility evaluation.
The reproducibility of Tm for each positive assay was also evaluated by site/system and overall (all sites/systems) and a summary is provided in Table 7.
| BCID Panel
Assay | Organism Tested
Test Concentration | Test
Site/System | Reproducibility of Tm
Syringe | | Reproducibility of Tm
Injection Vial | |
|------------------------|-----------------------------------------------------------------------------|----------------------|----------------------------------|-------------|-----------------------------------------|-------------|
| Gram-Positive Bacteria | | | Tm
Mean | Tm
StDev | Tm
Mean | Tm
StDev |
| Enterococcus | Enterococcus
faecalis [vanB]
JMI 368
8.95E+08 CFU/mL | A | 82.1 | ±0.3 | 82.0 | ±0.2 |
| | B | 81.9 | ±0.2 | 82.0 | ±0.3 | |
| | C | 81.6 | ±0.3 | 81.4 | ±0.3 | |
| | All
Sites/Systems | 81.9 | ±0.3 | 81.8 | ±0.4 | |
| Saureus | Staphylococcus
aureus [mecA]
ATCC BAA-1747
8.60E+06 CFU/mL | A | 77.3 | ±0.2 | 77.3 | ±0.2 |
| | B | 77.2 | ±0.2 | 77.1 | ±0.2 | |
| | C | 76.8 | ±0.2 | 76.7 | ±0.2 | |
| | All
Sites/Systems | 77.1 | ±0.3 | 77.0 | ±0.3 | |
| Gram-Negative Bacteria | | | | | | |
| Enteric | Klebsiella
pneumoniae [KPC]
JMI 766
9.40E+08 CFU/mL | A | 89.0 | ±0.3 | 88.9 | ±0.2 |
| | B | 88.7 | ±0.2 | 88.8 | ±0.2 | |
| | C | 88.3 | ±0.3 | 88.2 | ±0.3 | |
| | All
Sites/Systems | 88.7 | ±0.4 | 88.6 | ±0.4 | |
| Kpneumoniae | | A | 88.3 | ±0.2 | 88.2 | ±0.2 |
| | | B | 88.0 | ±0.1 | 88.1 | ±0.2 |
| | | C | 87.6 | ±0.3 | 87.5 | ±0.3 |
| | | All
Sites/Systems | 88.0 | ±0.3 | 87.9 | ±0.4 |
| Paeruginosa | Pseudomonas
aeruginosa
ATCC 27853
1.40E+08 CFU/mL | A | 88.3 | ±0.2 | 88.3 | ±0.2 |
| | B | 88.1 | ±0.2 | 88.1 | ±0.2 | |
| | C | 87.6 | ±0.3 | 87.5 | ±0.3 | |
| | All
Sites/Systems | 88.0 | ±0.4 | 88.0 | ±0.4 | |
| Yeast | | | | | | |
| Calbicans | Candida albicans
ATCC 10231
3.10E+04 CFU/mL | A | 80.1 | ±0.3 | 80.0 | ±0.3 |
| | B | 79.9 | ±0.2 | 79.9 | ±0.3 | |
| | C | 79.5 | ±0.3 | 79.4 | ±0.3 | |
| | All
Sites/Systems | 79.9 | ±0.4 | 79.8 | ±0.4 | |
| Ckrusei | Candida krusei
ATCC 90878
3.20E+07 CFU/mL | A | 84.6 | ±0.1 | 84.6 | ±0.2 |
| | B | 84.5 | ±0.2 | 84.5 | ±0.2 | |
| | C | 84.1 | ±0.3 | 84.0 | ±0.3 | |
| | All
Sites/Systems | 84.3 | ±0.3 | 84.2 | ±0.3 | |
Table 7. Tm Reproducibility Analysis (Within Site/System and Overall) for Positive FilmArray BCID Panel Assays on Multi-instrument FilmArray 2.0 Systems
BioFire Diagnostics, LLC 510(k) Multi-instrument FilmArray Blood Culture Identification Panel
24
| BCID Panel
Assay | Organism Tested
Test Concentration | | Test
Site/System | Reproducibility of Tm
Syringe | | Reproducibility of Tm
Injection Vial | |
|--------------------------------|---------------------------------------------------------------------|-----|----------------------|----------------------------------|-------------|-----------------------------------------|-------------|
| | | | All
Sites/Systems | Tm
Mean | Tm
StDev | Tm
Mean | Tm
StDev |
| | | | All
Sites/Systems | 84.4 | ±0.3 | 84.4 | ±0.4 |
| Antimicrobial Resistance Genes | | | | | | | |
| vanA/B | Enterococcus
faecium
[vanA]
JMI475
1.50E+08
CFU/mL | Tm1 | A | 81.8 | ±0.3 | 81.7 | ±0.2 |
| | | | B | 81.7 | ±0.2 | 81.7 | ±0.2 |
| | | | C | 81.3 | ±0.3 | 81.2 | ±0.2 |
| | | | All
Sites/Systems | 81.6 | ±0.3 | 81.5 | ±0.3 |
| vanA/B | Enterococcus
faecium
[vanA]
JMI475
1.50E+08
CFU/mL | Tm2 | A | 86.5 | ±0.2 | 86.4 | ±0.2 |
| | | | B | 86.3 | ±0.2 | 86.3 | ±0.2 |
| | | | C | 85.9 | ±0.3 | 85.7 | ±0.3 |
| | | | All
Sites/Systems | 86.2 | ±0.4 | 86.2 | ±0.4 |
| mecA | Staphylococcus
aureus [mecA]
ATCC BAA-1747
8.60E+06 CFU/mL | | A | 73.8 | ±0.2 | 73.7 | ±0.2 |
| | | | B | 73.7 | ±0.2 | 73.7 | ±0.2 |
| | | | C | 73.3 | ±0.3 | 73.2 | ±0.3 |
| | | | All
Sites/Systems | 73.6 | ±0.3 | 73.5 | ±0.3 |
| KPC | Klebsiella
pneumoniae [KPC]
JMI 766
9.40E+08 CFU/mL | | A | 86.5 | ±0.2 | 86.5 | ±0.2 |
| | | | B | 86.3 | ±0.2 | 86.3 | ±0.2 |
| | | | C | 85.9 | ±0.3 | 85.8 | ±0.3 |
| | | | All
Sites/Systems | 86.2 | ±0.4 | 86.2 | ±0.4 |