FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0

K143171 · Biofire Diagnostics, LLC · PEN · Jan 30, 2015 · Microbiology

Device Facts

• Record ID: K143171
• Device Name: FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
• Applicant: Biofire Diagnostics, LLC
• Product Code: PEN · Microbiology
• Decision Date: Jan 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3365
• Device Class: Class 2

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 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.

Device Story

The FilmArray BCID Panel is a multiplexed nucleic acid test for use with the FilmArray 2.0 system. It processes positive blood culture samples to identify 24 organisms/groups and 3 resistance markers (mecA, vanA/B, blaKPC). The system uses a disposable pouch containing freeze-dried reagents for automated nucleic acid extraction, nested multiplex PCR, and DNA melt analysis. The instrument uses pneumatic bladders and pistons to move fluids and Peltier devices for thermal cycling. A digital camera captures fluorescent images of the array. Software automatically interprets melt curves to provide results. The device is used in clinical laboratories to aid in the diagnosis of bloodstream infections, enabling faster identification than traditional culture methods, which benefits patients by potentially allowing for earlier targeted antimicrobial therapy.

Clinical Evidence

Bench testing and clinical performance evaluation were conducted. A study of 102 clinical specimens compared the current system to the modified system (FilmArray 2.0) using syringe and injection vial loading. Overall PPA was >99.1% and NPA >99.9% across all comparisons. Reproducibility studies across three sites, ten operators, and multiple instruments showed high agreement (>96.7%) with expected results for all analytes. Titration studies confirmed comparable detection limits and Tm values between configurations.

Technological Characteristics

Multiplex nucleic acid test; nested PCR with DNA melt analysis; uses LC Green Plus fluorescent dye. Reagents are freeze-dried in a disposable pouch. Instrumentation includes pneumatic bladders, pistons, and Peltier thermal control. Connectivity: FilmArray 2.0 supports up to eight instruments per computer. Software performs automated data interpretation. Sterilization: Not specified.

Indications for Use

Indicated for qualitative detection of bacterial/yeast nucleic acids and antimicrobial resistance genes in positive blood culture samples (Gram stain positive) to aid in diagnosis of bacteremia/fungemia. For use in clinical laboratories by trained personnel.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the Verigene® Gram Positive Blood Culture Nucleic Acid Test is subject to the following special controls: The special controls for the BC-GP Assay are contained in the guideline document entitled "Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures."

*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).

Predicate Devices

• FilmArray BCID Panel (K130914)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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.

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#### 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: [phone] 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

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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:<br>BCID Panel - FilmArray<br>(K130914) | New Device:<br>BCID Panel FilmArray 2.0 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Organisms Detected | Enterococci, Listeria monocytogenes,<br>Staphylococci (including specific<br>differentiation of Staphylococcus aureus),<br>Streptococci (with specific differentiation of<br>Streptococcus agalactiae, Streptococcus<br>pneumoniae, and Streptococcus pyogenes),<br>Acinetobacter baumannii, Enterobacteriaceae<br>(including specific differentiation of the<br>Enterobacter cloacae complex, Escherichia<br>coli, Klebsiella oxytoca, Klebsiella<br>pneumoniae, Proteus, and Serratia<br>marcescens), Haemophilus influenzae,<br>Neisseria meningitidis (encapsulated),<br>Pseudomonas aeruginosa, Candida albicans,<br>Candida glabrata, Candida krusei, Candida<br>parapsilosis, Candida tropicalis, and<br>resistance markers mecA, vanA, vanB, and<br>blaKPC (KPC) | Same |
| Analyte | RNA/DNA | Same |
| Specimen Types | Positive blood culture samples containing<br>gram-positive or gram-negative bacteria<br>and/or yeast. | Same |
| Technological<br>Principles | Nested multiplex RT-PCR followed by high<br>resolution melting analysis to confirm identity<br>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<br>generation. User cannot access raw data. | Same |
| Reagent Hydration and<br>Sample Loading | Syringe-based loading procedure | Syringe-based loading procedure<br>or FilmArray Injection Vial-based<br>loading procedure |
| Sample Preparation<br>Method | Sample processing is automated in the<br>FilmArray BCID pouch. | Same |
| Reagent Storage | Reagents are stored at room temperature. | Same |
| Controls | Two controls are included in each reagent<br>pouch to control for sample processing and<br>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

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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

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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<br>Type | | | MS+S vs CS+S | | | | MS+F vs MS+S | | | | MS+F vs CS+S | | | |
|------------------------------|------------------|-----|-------|--------------|--------|-------|-------|--------------|-------|------|-------|--------------|--------|-------|--|
| Analyte | PB<br>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

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| | | Specimen<br>Type | MS+S vs CS+S | | | MS+F vs MS+S | | | MS+F vs CS+S | | | | | | | | | |
|--------------------------------|---------|------------------|--------------|------|-----------|--------------|---------|-----------|--------------|------|-----------|------|-----------|-----------|--|--|-----------|--|
| Analyte | PB<br>C | SBC | PPA | % | NPA | % | PPA | % | NPA | % | PPA | % | NPA | % | | | | |
| <i>Candida tropicalis</i> | 3 | 2 | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | 5/5 | 100% | 95/95 | 100% | | | | |
| Antimicrobial Resistance Genes | | | | | | | | | | | | | | | | | | |
| <i>mecA</i> | 6 | 0 | 5/5 | 100% | 5/5c | 100% | 6/6 | 100% | 5/5 | 100% | 5/5c | 100% | 5/5c | 100% | | | | |
| <i>vanA/B</i> | 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<br>Test Result | Test Level | Current System<br>(Syringe) | Modified System<br>(Syringe) | Modified System<br>(Injection Vial) |
|------------------------------------------------------|---------------------------------|------------|-------------------------------|-------------------------------|-------------------------------------|
| GRAM-POSITIVE BACTERIA | | | | | |
| <i>Enterococcus faecalis (vanB)</i><br>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%) | | |
| <i>Enterococcus faecalis (vanB)</i><br>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%) | | |
| <i>Enterococcus faecium (vanA)</i><br>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%) | | |
| <i>Enterococcus faecium (vanA)</i><br>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%) | | |
| <i>Listeria monocytogenes</i><br>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%) | | |
| <i>Staphylococcus aureus (mecA)</i><br>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%) | | |
| <i>Staphylococcus aureus (mecA)</i><br>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<br>Test Result | Test Level | Current System<br>(Syringe) | Modified System<br>(Syringe) | Modified System<br>(Injection Vial) |
| Staphylococcus<br>epidermidis<br>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<br>mitis<br>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<br>agalactiae<br>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<br>pneumoniae a<br>ATCC BAA-255 | Streptococcus | 1× a | 5/5 (100%) | Same | Same |
| | | 0.1× a | 5/5 (100%) | | |
| | | 0.01× a | 5/5 (100%) | | |
| | Streptococcus<br>pneumoniae | 0.001× a | 5/5 (100%) | | |
| Streptococcus<br>pyogenes<br>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<br>baumannii<br>ATCC 9955 | Acinetobacter<br>baumannii | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | | 0.001× | 5/5 (100%) | | |
| Enterobacter<br>cloacae<br>ATCC 13047 | Enterobacteriaceae | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| | Enterobacter cloacae<br>complex | 0.001× | 3/5 (60%) | | |
| Escherichia coli<br>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<br>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<br>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<br>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<br>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<br>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<br>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<br>ATCC 15545 | Candida glabrata | 1× | 5/5 (100%) | Same | Same |
| | | 0.1× | 5/5 (100%) | | |
| | | 0.01× | 5/5 (100%) | | |
| Organism | FilmArray BCID<br>Test Result | Test Level | # Detected/Total (% Detected) | | |
| | | | Current System<br>(Syringe) | Modified System<br>(Syringe) | Modified System<br>(Injection Vial) |
| Candida krusei<br>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<br>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<br>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<br>(Loading Procedure) | Mean<br>Tma | △ Mean Tm<br>System | △Tm<br>Loading | △Tm<br>Combined |
|---------------------------------|------------------|-----------------------------------------|-------------|---------------------|----------------|-----------------|
| Enterococcus faecium<br>(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<br>(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<br>(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<br>(Loading Procedure) | Mean<br>Tmᵃ | ΔTm<br>System | ΔTm<br>Loading | ΔTm<br>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<br>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<br>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<br>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<br>baumannii | Abaumannii | Current (Syringe) | 80.3 | 0.1 | | -0.1 |
| | | Modified (Syringe) | 80.2 | | -0.2 | |
| | | Modified (Injection Vial) | 80.4 | | | |
| Enterobacter<br>cloacae | Enteric | Current (Syringe) | 87.6 | 0.2 | | 0.0 |
|…