BioFire Blood Culture Identification 2 (BCID2) Panel
Device Facts
| Record ID | K193519 |
|---|---|
| Device Name | BioFire Blood Culture Identification 2 (BCID2) Panel |
| Applicant | Biofire Diagnostics, LLC |
| Product Code | PEN · Microbiology |
| Decision Date | Mar 18, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3365 |
| Device Class | Class 2 |
Intended Use
The BioFire® Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with FilmArray® 2.0 or FilmArray® Torch systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BioFire BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The following organism types and subtypes are identified using the BioFire BCID2 Panel: Gram Positive Bacteria - Enterococcus faecalis - Staphylococcus spp. - Streptococcus spp. - Enterococcus faecium - Staphylococcus aureus - Streptococcus agalactiae (Group B) - Listeria monocytogenes - Staphylococcus epidermidis - Streptococcus pneumoniae - Staphylococcus lugdunensis - Streptococcus pyogenes (Group A) Gram Negative Bacteria - Acinetobacter calcoaceticus-baumannii complex - Enterobacterales - Bacteroides fragilis - Enterobacter cloacae complex - Haemophilus influenza - Escherichia coli - Neisseria meningitidis (encapsulated) - Klebsiella aerogenes - Pseudomonas aeruginosa - Klebsiella oxytoca - Stenotrophomonas maltophilia - Klebsiella pneumoniae group - Proteus spp. - Salmonella spp. - Serratia marcescens Yeast - Candida albicans - Candida krusei - Cryptococcus neoformans/gattii - Candida auris - Candida parapsilosis - Candida tropicalis The BioFire BCID2 Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA/C and mecA/C in conjunction with MREJ, vancomycin (vanA and vanB), 0-lactams including penicillins, cephalosporins, monobactams, and carbapenems (blaCTX-M, blaKPC, blaNDM, blaOXA48-like, bla VIM) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In addition, the panel includes an assay for the mobilized genetic determinant mcr-1, an emerging marker of public health importance. The animicrobial resistance gene or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, B-lactams, and colistin exist. Antimicrobial Resistance Genes - CTX-M - КРС - mecA/C - NDM - vanA/B - IMP - mcr-1 - mecA/C and MREJ (MRSA) - OXA-48-like - VIM The BioFire BCID2 Panel is indicated as an aid in the diagnosis of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. Positive results do not rule out co-infection with organisms not included in the BioFire BCID2 Panel is not intended to monitor treatment for bloodstream infection. 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 BioFire BCID2 Panel, and for determination of species detected but not identified within complexes, groups, or genera by the BioFire BCID2 Panel assays.
Device Story
The BioFire BCID2 Panel is a multiplexed nucleic acid test for positive blood culture samples. It identifies 43 bacteria/yeast and select antimicrobial resistance (AMR) genes. The device uses a FilmArray pouch containing freeze-dried reagents; the user adds hydration solution and sample buffer mixed with the positive blood culture specimen. The FilmArray instrument performs automated mechanical lysis, nucleic acid extraction, and nested multiplex PCR. The first stage is a large-volume multiplexed RT-PCR; the second stage is singleplex PCR in array wells. Melt curve analysis detects signature amplicons. A digital camera captures fluorescent images, and software automatically interprets results. The test takes about one hour. It is used in clinical laboratories by technicians. Results aid clinicians in determining appropriate patient treatment and management. It benefits patients by providing rapid identification of bloodstream pathogens and resistance markers, enabling targeted therapy.
Clinical Evidence
Clinical performance was established via a prospective multi-center study (1,074 specimens), supplemented by archived (370 specimens) and seeded (552 specimens) studies. Performance was compared to standard microbiological/biochemical methods and sequencing. Overall sensitivity/specificity for most analytes exceeded 95%. Key results: Enterococcus faecalis (95.3% sensitivity, 99.9% specificity), Staphylococcus aureus (100% sensitivity, 99.9% specificity), and various AMR genes (e.g., CTX-M 99.1% sensitivity, 100% specificity).
Technological Characteristics
Nested multiplex PCR with melt curve analysis. Reagents in freeze-dried format. Instrumentation: FilmArray 2.0 or FilmArray Torch. Connectivity: Standalone/networked. Sterilization: Not applicable (single-use disposable pouch). Software: Automated interpretation.
Indications for Use
Indicated for qualitative detection/identification of bacterial/yeast nucleic acids and antimicrobial resistance markers in positive blood culture samples. Intended for use with FilmArray 2.0 or Torch systems as an aid in diagnosing bloodstream infections. Not for monitoring treatment. Requires interpretation with Gram stain results. Subculturing required for susceptibility testing/epidemiological typing.
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 Blood Culture Identification (BCID) Panel (K181493)
Related Devices
- K130914 — FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL · Biofire Diagnostics, Inc. · Jun 21, 2013
- K143171 — FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 · Biofire Diagnostics, LLC · Jan 30, 2015
- K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) · Biofire Diagnostics, LLC · Dec 20, 2024
- K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch · Biofire Diagnostics, LLC · Mar 15, 2016
- K181493 — FilmArray Blood Culture Identification (BCID) Panel · Biofire Diagnostics, LLC · Jul 5, 2018
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 18, 2020
BioFire Diagnostics, LLC Kristen Kanack Senior Vice President, Regulatory and Clinical Affairs 515 Colorow Drive Salt Lake City, Utah 84108
# Re: K193519
Trade/Device Name: BioFire Blood Culture Identification 2 (BCID2) Panel Regulation Number: 21 CFR 866.3365 Regulation Name: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures Regulatory Class: Class II Product Code: PAM, PEO Dated: December 18, 2019 Received: December 19, 2019
# Dear Kristen 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{1}------------------------------------------------
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kristian Roth. Ph.D. Chief Bacterial Multiplex and Medical Counter Measures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K193519
## Device Name
BioFire Blood Culture Identification 2 (BCID2) Panel
## Indications for Use (Describe)
The BioFire® Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with FilmArray® 2.0 or FilmArray® Torch systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BioFire BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The following organism types and subtypes are identified using the BioFire BCID2 Panel:
Gram Positive Bacteria
- Enterococcus faecalis
- · Staphylococcus spp.
- · Streptococcus spp.
- Enterococcus faecium
- Staphylococcus aureus
- · Streptococcus agalactiae (Group B)
- Listeria monocytogenes
- Staphylococcus epidermidis
- Streptococcus pneumoniae
- Staphylococcus lugdunensis
- · Streptococcus pyogenes (Group A)
Gram Negative Bacteria
- Acinetobacter calcoaceticus-baumannii complex
- · Enterobacterales
- · Bacteroides fragilis
- Enterobacter cloacae complex
- Haemophilus influenza
- · Escherichia coli
- · Neisseria meningitidis (encapsulated)
- · Klebsiella aerogenes
- · Pseudomonas aeruginosa
- · Klebsiella oxytoca
- · Stenotrophomonas maltophilia
- · Klebsiella pneumoniae group
- · Proteus spp.
- · Salmonella spp.
- · Serratia marcescens
## Yeast
- · Candida albicans
- Candida krusei
- · Cryptococcus neoformans/gattii
- Candida auris
- · Candida parapsilosis
{3}------------------------------------------------
- · Candida tropicalis
The BioFire BCID2 Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA/C and mecA/C in conjunction with MREJ, vancomycin (vanA and vanB), 0-lactams including penicillins, cephalosporins, monobactams, and carbapenems (blaCTX-M, blaKPC, blaNDM, blaOXA48-like, bla VIM) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In addition, the panel includes an assay for the mobilized genetic determinant mcr-1, an emerging marker of public health importance. The animicrobial resistance gene or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, B-lactams, and colistin exist.
Antimicrobial Resistance Genes
- CTX-M
- КРС
- · mecA/C
- NDM
- vanA/B
- · IMP
- mcr-1
- · mecA/C and MREJ (MRSA)
- OXA-48-like
- VIM
The BioFire BCID2 Panel is indicated as an aid in the diagnosis of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. Positive results do not rule out co-infection with organisms not included in the BioFire BCID2 Panel is not intended to monitor treatment for bloodstream infection.
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 BioFire BCID2 Panel, and for determination of species detected but not identified within complexes, groups, or genera by the BioFire BCID2 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
<sup>•</sup> Candida glabrata
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for BioFire Diagnostics, Inc. The logo consists of the word "BIO FIRE" in a sans-serif font, with a stylized red DNA helix symbol between the two words. Below the main logo is the text "BY BIOMÉRIEUX" in a smaller, sans-serif font.
# BioFire® Blood Culture Identification 2 (BCID2) Panel 510(k) Summary BioFire Diagnostics, LLC
# 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 515 Colorow Drive Salt Lake City, UT 84108 Telephone: 801-736-6354 Facsimile: 801-588-0507 Contact: Kristen J. Kanack, ext. 1330 Date Submitted: December 18, 2019
# Device Name and Classification:
Trade Name: BioFire® Blood Culture Identification 2 (BCID2) Panel
Requlation Number: 21 CFR 866.3365
Classification Name: Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
# Predicate Device:
K181493 - FilmArray® Blood Culture Identification (BCID) Panel
# Intended Use:
The BioFire® Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with FilmArray® 2.0 or FilmArray® Torch systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BioFire BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The following organism types and subtypes are identified using the BioFire BCID2 Panel:
{5}------------------------------------------------
| Gram Positive Bacteria | | |
|-----------------------------------------------|------------------------------|------------------------------------|
| Enterococcus faecalis | Staphylococcus spp. | Streptococcus spp. |
| Enterococcus faecium | Staphylococcus aureus | Streptococcus agalactiae (Group B) |
| Listeria monocytogenes | Staphylococcus epidermidis | Streptococcus pneumoniae |
| | Staphylococcus lugdunensis | Streptococcus pyogenes (Group A) |
| Gram Negative Bacteria | | |
| Acinetobacter calcoaceticus-baumannii complex | Enterobacterales | |
| Bacteroides fragilis | Enterobacter cloacae complex | |
| Haemophilus influenzae | Escherichia coli | |
| Neisseria meningitidis (encapsulated) | Klebsiella aerogenes | |
| Pseudomonas aeruginosa | Klebsiella oxytoca | |
| Stenotrophomonas maltophilia | Klebsiella pneumoniae group | |
| | Proteus spp. | |
| | Salmonella spp. | |
| | Serratia marcescens | |
| Yeast | | |
| Candida albicans | Candida krusei | Cryptococcus neoformans/gattii |
| Candida auris | Candida parapsilosis | |
| Candida glabrata | Candida tropicalis | |
The BioFire BCID2 Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA/C and mecA/C in conjunction with MREJ), vancomycin (vanA and vanB), (s-lactams including penicillins, cephalosporins, monobactams, and carbapenems (black., blawp, blavni, blavin) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In addition, the panel includes an assay for the detection of the mobilized genetic determinant mcr-1, an emerging marker of public health importance. The antimicrobial resistance gene or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, ß-lactams, and colistin exist.
| Antimicrobial Resistance Genes | | | | |
|--------------------------------|-------|------------------------|-------------|--------|
| CTX-M | KPC | mecA/C | NDM | vanA/B |
| IMP | mcr-1 | mecA/C and MREJ (MRSA) | OXA-48-like | VIM |
The BioFire BCID2 Panel is indicated as an aid in the diagnosis of specific agents of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. Postive results do not rule out coinfection with organisms not included in the BioFire BCID2 Panel is not intended to monitor treatment for blood stream infection.
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 BioFire BCID2 Panel, and for determination of species detected but not identified within complexes, groups, or genera by the BioFire BCID2 Panel assays.
# Device Description:
The BioFire Blood Culture Identification 2 (BCID2) Panel is designed to simultaneously identify 43 bacteria and yeast responsible for bloodstream infections, as well as select genetic determinants of antimicrobial resistance (see Table 1), in a timeframe(about an hour) that allows the test results to be used in determining appropriate patient treatment and management. The BioFire BCID2 Panel is performed directly on positive blood culture samples.
{6}------------------------------------------------
The BioFire BCID2 Panel is compatible with BioFire's PCR-based in vitro diagnostic FilmArray Torch systems for infectious disease testing, A specific software module (i.e., BioFire BCID2 Panel pouch module) is used to perform BioFire BCID2 Panel testing on these systems.
| Table 1. Analytes detected by the BioFire BCID2 Panel | | |
|-------------------------------------------------------|------------------------------|------------------------------------|
| Gram Positive Bacteria | | |
| Enterococcus faecalis | Staphylococcus spp. | Streptococcus spp. |
| Enterococcus faecium | Staphylococcus aureus | Streptococcus agalactiae (Group B) |
| Listeria monocytogenes | Staphylococcus epidermidis | Streptococcus pneumoniae |
| | Staphylococcus lugdunensis | Streptococcus pyogenes (Group A) |
| Gram Negative Bacteria | | |
| Acinetobacter calcoaceticus-baumannii complex | Enterobacterales | |
| Bacteroides fragilis | Enterobacter cloacae complex | |
| Haemophilus influenzae | Escherichia coli | |
| Neisseria meningitidis | Klebsiella aerogenes | |
| Pseudomonas aeruginosa | Klebsiella oxytoca | |
| Stenotrophomonas maltophilia | Klebsiella pneumoniae group | |
| | Proteus spp. | |
| | Salmonella spp. | |
| | Serratia marcescens | |
| Yeast | | |
| Candida albicans | Candida krusei | Cryptococcus neoformans/gattii |
| Candida auris | Candida parapsilosis | |
| Candida glabrata | Candida tropicalis | |
| Antimicrobial Resistance Genes | | |
| CTX-M | KPC | mecA/C |
| IMP | <i>mcr-1</i> | <i>mecA/C</i> and MREJ (MRSA) |
| | | NDM |
| | | OXA-48-like |
| | | vanA/B |
| | | VIM |
A test is initiated by loading Hydration Solution into one port of the FilmArray pouch and positive blood culture specimen mixed with the provided Sample Buffer into the other port of the BioFire BCID2 Panel pouch and placing it in a FilmArray instrument. The pouch contains all of the reagents required for specimen testing and analysis in a freeze-dried format: the addition of Hydration and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the FilmArray Software quides the user through the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.
The FilmArray instruments contain coordinated systems 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 PCR reactions and the melt curve analysis.
Nucleic acid extraction occurs within the FilmArray pouch using mechanical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the FilmArray performs a nested multiplex PCR that is executed in two stages. During the first stage, the FilmArray performs a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent double-stranded DNA binding dye (LC Green® Plus, BioFire Diagnostics). 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, is is performed in singleplex fashion in each well of the conclusion of the 2nd stage PCR, the array is
{7}------------------------------------------------
interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.
The FilmArray Software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel.
# Substantial Equivalence:
The BioFire Blood Culture Identification 2 (BCID2) Panel is substantially equivalent to the FilmArray Blood Culture ldentification (BCID) Panel Application (K181493), which was cleared on Jul 07, 2018 and determined to be a Class II device under the classification code 21 CFR 866.3365.
Table 2 compares the BioFire BCID2 Panel to the FilmArray BCID Panel and outlines the similarities and differences between the two systems.
| Element | Subject Device:<br>BioFire Blood Culture Identification 2 (BCID2) Panel | Predicate:<br>FilmArray Blood Culture Identification (BCID) Panel<br>K181493 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specimen Type | Blood culture samples identified as positive by a<br>continuous monitoring blood culture system. | Same |
| Organisms Detected | Gram-positive Bacteria<br>Enterococcus faecalis, Enterococcus faecium, Listeria<br>monocytogenes, Staphylococcus spp. (with specific<br>differentiation of Staphylococcus aureus,<br>Staphylococcus epidermidis, and Staphylococcus<br>lugdunensis), Streptococcus spp. (with specific<br>differentiation of Streptococcus agalactiae (Group B),<br>Streptococcus pneumoniae, and Streptococcus<br>pyogenes (Group A)) | Gram-positive Bacteria<br>Enterococcus spp., Listeria monocytogenes,<br>Staphylococcus spp.(including specific differentiation of<br>Staphylococcus aureus), Streptococcus spp. (with<br>specific differentiation of Streptococcus agalactiae,<br>Streptococcus pneumoniae, and Streptococcus<br>pyogenes) |
| | Gram-negative Bacteria<br>Acinetobacter calcoaceticus-baumannii complex,<br>Bacteroides fragilis, Haemophilus influenzae, Neisseria<br>meningitidis (encapsulated), Pseudomonas<br>aeruginosa, Stenotrophomonas maltophilia,<br>Enterobacterales (with specific differentiation of<br>Enterobacter cloacae complex, Escherichia coli,<br>Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella<br>pneumoniae group, Proteus spp., Salmonella spp., and<br>Serratia marcescens) | Gram-negative Bacteria<br>Acinetobacter baumannii, Enterobacteriaceae<br>(including specific differentiation of the Enterobacter<br>cloacae complex, Escherichia coli, Klebsiella oxytoca,<br>Klebsiella pneumoniae, Proteus, and Serratia<br>marcescens), Haemophilus influenzae, Neisseria<br>meningitidis (encapsulated), Pseudomonas aeruginosa |
| | Yeast<br>Candida albicans, Candida auris, Candida glabrata,<br>Candida krusei, Candida parapsilosis, Candida<br>tropicalis, and Cryptococcus neoformans/gatti | Yeast<br>Candida albicans, Candida glabrata, Candida krusei,<br>Candida parapsilosis, Candida tropicalis |
| | Antimicrobial Resistance Genes<br>CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ<br>(MRSA), NDM, OXA-48-like, vanA/B, VIM | Antimicrobial Resistance Genes<br>mecA (detects mecA and mecC), vanA/B, and KPC |
| Analyte | DNA | Same |
| Technological<br>Principles | Highly-multiplexed nested nucleic acid amplification<br>test with melt analysis | Same |
| Instrumentation | FilmArray 2.0 or FilmArray Torch | FilmArray, FilmArray 2.0, or FilmArray Torch |
| Time to result | About 1 hour | Same |
| Reagent Storage | Room temperature | Same |
| Element | Subject Device:<br>BioFire Blood Culture Identification 2 (BCID2) Panel | Predicate:<br>FilmArray Blood Culture Identification (BCID) Panel<br>K181493 |
| Test Interpretation | Automated test interpretation and report generation.<br>User cannot access raw data. | Same |
| Controls | Two controls are included in each reagent pouch to<br>control for sample processing and both stages of PCR<br>and melt analysis. | Same |
| User Complexity | Moderate/Low | Same |
## Table 2. Comparison of the BioFire BCID2 Panel and the FilmArray BCID Panel
{8}------------------------------------------------
# Summary of Performance Data
# Clinical Performance
The clinical performance of the BioFire BCID2 Panel was established during a prospective multi-center study that was further supplemented with archived and seeded PBC specimens.
Blood culture bottle types evaluated in the prospective clinical study included 11 different media from two different manufacturers as shown in Table 3. Equivalent overall performance was observed when results from the different media were compared; therefore, the data collected from all media types are combined for all analyses. One exception was the detection of 53 false-positive Enterobacterales results from a limited number of lots of media identified to contain nucleic acid from non-viable E. coli; tables containing these data are footnoted.
| | Manufacturer and Product Name | Prospective Study | | | Seeded Study | | |
|-------------------------|--------------------------------|-------------------|----------------------|---------------------|--------------|----------------------|---------------------|
| Blood Culture | | N | Overall Performancea | | | Overall Performancea | |
| Media Type | | | Sensitivity/<br>PPA | Specificity/<br>NPA | N | Sensitivity/<br>PPA | Specificity/<br>NPA |
| Aerobic | BD Bactec Plus Aerobic/F | 344 | 98.8% | 99.8% | 354 | 99.2% | 100% |
| | BD Standard 10 Aerobic/F | 3 | 100% | 100% | 0 | - | - |
| | bioMérieux BacT/ALERT FA plus | 264 | 98.8% | 99.0% | 168 | 99.0% | 100% |
| | bioMérieux BacT/ALERT SA | 21 | 100% | 99.5% | 0 | - | - |
| Anaerobic | BD Bactec Plus Anaerobic/F | 86 | 99.1% | 99.9% | 15b | 100% | 100% |
| | BD Bactec Standard Anaerobic/F | 1 | 100% | - | 0 | - | - |
| | BD Bactec Lytic/10 Anaerobic/F | 187 | 99.6% | 99.9% | 0 | - | - |
| | bioMérieux BacT/ALERT FN plus | 40 | 100% | 99.8% | 15 | 100% | 100% |
| | bioMérieux BacT/ALERT SN | 83 | 97.9% | 100% | 0 | - | - |
| Pediatric/Low<br>Volume | BD Bactec Peds Plus/F | 13 | 100% | 99.6% | 0 | - | - |
| | bioMérieux BacT/ALERT PF plus | 32 | 95.8% | 98.8% | 0 | - | - |
Table 3. Blood Culture Media Types Evaluated in the BioFire BCID2 Panel Prospective Clinical Evaluation
® Note that these calculations do not includual Staphylococus species, individual Streptococus species, or individual Enterobacterales interpretations, as the grouped Staphylococus spp., and Enterobacterales interpretations are included instead. bBacteroides fragilis only
Nine geographically distinct study sites (seven in the EU) participated in the prospective clinical evaluation from October 2018 to May 2019. A total of 11 pouch lots were used for testing.
A total of 1093 residual PBC specimens were acquired for the prospective clinical study. At two of the US sites, 69 specimens enrolled between October 2018 and February 2019 were collected and immediately frozen for later testing at the source laboratory. The remaining 1024 specimens were collected and tested fresh. No difference in performance was observed when fresh and frozen specimen results were compared. Therefore, the data collected from 69 valid frozen specimens are combined with data from the valid 1005 fresh specimens for all analyses.
Nineteen (19) specimens were excluded from the final data analysis. The most common reason for specimen exclusion was that the specimen was found to not meet the inclusion criteria after the specimen was enrolled, most
{9}------------------------------------------------
often due to the specimen being tested with the BioFire BCID2 Panel outside of the 24-hour window following positive indication by the continuous monitoring blood culture system.
For the prospective study, the performance of the BioFire BCID2 Panel was evaluated by comparing the test result for each analyte with the appropriate comparator/reference methods shown in Table 4.
| BioFire BCID2 Panel Result | Reference / Comparator Method(s) | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Bacteria and Cryptococcus | Standard manual and automated microbiological/biochemical identification methods<br>(performed for SOC and abstracted from the subject medical chart) | | | |
| Candida species | SOC identification for genus level<br>followed by PCR & sequencing of isolates for species identification | | | |
| AMR Genes | Method 1 - Assessment of BioFire BCID2 Panel performance<br>(i) One PCR assay performed direct from PBC followed by sequencing of PCR amplicon<br>(CTX-M, IMP, KPC, NDM, OXA-48 like, VIM, and mcr-1)<br>(ii) Commercially available FDA-cleared and CE-marked molecular IVD assays performed on PBC<br>( <i>mecA/C</i> , <i>mecA/C</i> and MREJ (MRSA), KPC, and <i>vanA/B</i> )<br>Method 2 - Assessment of genotype concordance<br>PCR & sequencing for specific resistance gene from applicable cultured isolates<br>Method 3 - Assessment of phenotype concordance | | | |
pective BioFire BCID2 Panel Clinical Evaluation
To supplement the prospective study for low prevalence analytes, a total of 427 frozen archived PBC specimens were collected from 12 external laboratories and retrospectively tested. Of these, 395 were evaluable. Prior to testing with the BioFire BCID2 Panel, the composition/integrity of the specimens was first confirmed with confirmatory molecular methods; 370 specimens contained confirmed analytes of interest.
Table 5 provides a summary of demographic information for the 1074 specimens included in the prospective study and the 370 specimens included in the archived study.
| | | Prospective | Archived |
|-----|-------------|-------------|-----------|
| Sex | Male | 573 (53%) | 205 (55%) |
| | Female | 501 (47%) | 156 (42%) |
| | Unknown | 0 (0%) | 9 (2%) |
| Age | <1 year | 118 (11%) | 22 (6%) |
| | 1-17 years | 143 (13%) | 32 (9%) |
| | 18-44 years | 125 (12%) | 44 (12%) |
| | 45-64 years | 257 (24%) | 112 (30%) |
| | 65-84 years | 333 (31%) | 132 (36%) |
| | 85+ years | 98 (9%) | 27 (7%) |
| | Unknown | 0 (0%) | 1 (<1%) |
| | Total | 1074 | 370 |
## Table 5. Demographic Data for Prospective study
A total of 552 seeded blood culture specimens were also evaluated to further supplement the prospective and archived studies for low prevalence analytes (including AMR genes) and to assess performance in seeded polymicrobial specimens. Seeded PBC specimens were prepared by inoculating human whole blood with a variety of different isolates/strains for each analyte at low concentrations and growing to positivity in a continuous monitoring blood culture system. The number of analytes tested, and the purpose of including each analyte in the seeded study is presented in Table 6 and Table 7.
{10}------------------------------------------------
| Table 6. Seeded Specimen Analyte Composition | | |
|------------------------------------------------------------|------------------------------------|----------------|
| Purpose | Analyte | Number Testeda |
| Low Prevalence Analyte | Listeria monocytogenes | 36 |
| | Staphylococcus lugdunensis | 30 |
| | Bacteroides fragilis | 30 |
| | Klebsiella aerogenes | 42 |
| | Neisseria meningitidis | 35 |
| | Salmonella spp. | 37 |
| | Stenotrophomonas maltophilia | 30 |
| | Candida auris | 30 |
| | Candida krusei | 33 |
| | Candida tropicalis | 35 |
| | Cryptococcus neoformans/gattii | 30 |
| | IMP | 30 |
| | KPC | 45 |
| | NDM | 30 |
| | OXA-48-like | 30 |
| | VIM | 30 |
| | mcr-1 | 30 |
| Evaluation of Polymicrobial<br>Specimens | E. faecalis | 10 |
| | E. faecium | 10 |
| | S. aureus | 10 |
| | mecA/C and MREJ | 5 |
| | C. albicans | 10 |
| | A. calcoaceticus-baumannii complex | 19 |
| AMR Gene Host and Evaluation<br>of Polymicrobial Specimens | K. pneumoniae group | 92 |
| | E. coli | 44 |
| | P. aeruginosa | 26 |
| AMR Gene Host | E. cloacae complex | 8 |
| | K. oxytoca | 6 |
| | Proteus | 9 |
| Present in Host with other Rare<br>AMR Genes | CTX-M | 63 |
ª552 seeded specimens total including some with polymicrobial composition or Detected results reporting both an AMR gene and host organism
| Table 7. Strains and Replicates Tested in Seeded Specimens | | |
|------------------------------------------------------------|--|--|
|------------------------------------------------------------|--|--|
| Organism | AMR Gene(s) | Strain | Independent Specimens<br>Tested |
|--------------------------------------|---------------------------|---------------------------------|---------------------------------|
| Acinetobacter baumannii | --- | 2 Individual clinical isolates | 5 each (10) |
| Acinetobacter baumannii | NDM-1 | AR-BANK #0083 | 3 |
| Acinetobacter baumannii | NDM-1 | AR-BANK #0088 | 3 |
| Acinetobacter baumannii | IMP-4 | Individual clinical isolate | 3 |
| Acinetobacter baumannii total | | | 19 |
| Bacteroides fragilis | --- | ATCC 29771 | 3 |
| Bacteroides fragilis | --- | ATCC 23745 | 3 |
| Organism | AMR Gene(s) | Strain | Independent Specimens<br>Tested |
| | --- | ATCC 25285 | 3 |
| | --- | ATCC 29768 | 3 |
| | --- | ATCC 43858 | 3 |
| | --- | ATCC 43860 | 3 |
| | --- | ATCC 43936 | 3 |
| | --- | ATCC 43937 | 3 |
| | --- | ATCC BAA-2283 | 3 |
| | --- | Individual clinical isolate | 3 |
| Bacteroides fragilis total | | | 30 |
| Candida albicans | --- | 2 Individual clinical isolates | 5 each (10) |
| Candida albicans total | | | 10 |
| | --- | AR-BANK #0381 | 3 |
| | --- | AR-BANK #0382 | 3 |
| | --- | AR-BANK #0383 | 3 |
| | --- | AR-BANK #0384 | 3 |
| | --- | AR-BANK #0385 | 3 |
| Candida auris | --- | AR-BANK #0386 | 3 |
| | --- | AR-BANK #0387 | 3 |
| | --- | AR-BANK #0388 | 3 |
| | --- | AR-BANK #0389 | 3 |
| | --- | AR-BANK #0390 | 3 |
| Candida auris total | | | 30 |
| | --- | ATCC 14243 | 15 |
| Candida krusei | --- | ATCC 6258 | 3 |
| | --- | 15 Individual clinical isolates | 1 each (15) |
| Candida krusei total | | | 33 |
| Candida tropicalis | --- | 35 Individual clinical isolates | 1 each (35) |
| Candida tropicalis total | | | 35 |
| | --- | Individual clinical isolate | 3 |
| | --- | ATCC 56989 | 3 |
| Cryptococcus gattii | --- | ATCC 56992 | 3 |
| | --- | ATCC 64062 | 3 |
| | --- | ATCC MYA-4560 | 3 |
| Cryptococcus gattii total | | | 15 |
| | --- | 4 Individual clinical isolates | 3 each (12) |
| Cryptococcus neoformans | --- | ATCC 13690 | 3 |
| Cryptococcus neoformans total | | | 15 |
| | NDM-1, CTX-M-15 | AR-BANK #0038 | 3 |
| Enterobacter cloacae | VIM-1 | AR-BANK #0154 | 3 |
| | KPC | 2 Individual clinical isolates | 1 each (2) |
| Enterobacter cloacae total | | | 8 |
| Enterococcus faecalis | --- | 2 Individual clinical isolates | 5 each (10) |
| Enterococcus faecalis total | | | 10 |
| Organism | AMR Gene(s) | Strain | Independent Specimens Tested |
| Enterococcus faecium | --- | 2 Individual clinical isolates | 5 each (10) |
| Enterococcus faecium total | | | 10 |
| | NDM-1 | AR-BANK #0069 | 3 |
| | CTX-M-55, mcr-1 | AR-BANK #0346 | 4 |
| | CTX-M-14, CTX-M-55, mcr-1 | AR-BANK #0349 | 4 |
| | mcr-1 | AR-BANK #0350 | 3 |
| | mcr-1 | AR-BANK #0493 | 4 |
| | mcr-1 | AR-BANK #0494 | 4 |
| Escherichia coli | CTX-M, mcr-1 | AR-BANK #0495 | 3 |
| | NDM-1 | ATCC BAA-2452 | 3 |
| | IMP-4 | Individual clinical isolate | 3 |
| | IMP-3 | Individual clinical isolate | 3 |
| | IMP-9 | Individual clinical isolate | 3 |
| | VIM-7 | Individual clinical isolate | 3 |
| | KPC | Individual clinical isolate | 4 |
| Escherichia coli total | | | 44 |
| | --- | 10 Individual clinical isolates | 3 each (30) |
| | --- | 2 Individual clinical isolates | 1 each (2) |
| Klebsiella aerogenes | OXA-48 | AR-BANK #0074 | 3 |
| | IMP-4 | AR-BANK #0161 | 4 |
| | CTX-M | Individual clinical isolate | 3 |
| Klebsiella aerogenes total | | | 42 |
| | KPC-3 | AR-BANK #0147 | 3 |
| Klebsiella oxytoca | CTX-M | Individual clinical isolate | 3 |
| Klebsiella oxytoca total | | | 6 |
| | --- | 2 Individual clinical isolates | 5 each (10) |
| | IMP-4 | AR-BANK #0034 | 3 |
| | OXA-181; CTX-M-15 | AR-BANK #0039 | 3 |
| | VIM-27; CTX-M-15 | AR-BANK #0040 | 3 |
| | VIM-27; CTX-M-15 | AR-BANK #0046 | 3 |
| | OXA-181, CTX-M-15 | AR-BANK #0051 | 3 |
| | OXA232; CTX-M-15 | AR-BANK #0066 | 3 |
| | OXA-232; CTX-M-15 | AR-BANK #0075 | 3 |
| | IMP-4 | AR-BANK #0080 | 3 |
| Klebsiella pneumoniae | VIM-1 | AR-BANK #0135 | 3 |
| | NDM-7; CTX-M-15 | AR-BANK #0138 | 3 |
| | OXA-181; CTX-M-15 | AR-BANK #0140 | 3 |
| | OXA-181; CTX-M-15 | AR-BANK #0141 | 3 |
| | OXA-181; CTX-M-15 | AR-BANK #0142 | 3 |
| | NDM-1; OXA-232; CTX-M-15 | AR-BANK #0153 | 3 |
| | OXA-48 | AR-BANK #0160 | 3 |
| | mcr-1 | AR-BANK #0497 | 4 |
| | NDM-1; CTX-M | ATCC BAA-2146 | 3 |
| Organism | AMR Gene(s) | Strain | Independent Specimens<br>Tested |
| Klebsiella pneumoniae | KPC | Individual clinical isolate | 8 |
| | KPC | 22 Individual clinical isolates | 1 each (22) |
| Klebsiella pneumoniae total | | | 92 |
| | --- | ATCC 19115 | 8 |
| | --- | ATCC 35152 | 1 |
| | --- | ATCC 43248 | 5 |
| Listeria monocytogenes | --- | ATCC 51779 | 5 |
| | --- | Individual clinical isolate | 2 |
| | --- | 7 Individual clinical isolates | 1 each (7) |
| | --- | NCTC 10890 | 8 |
| Listeria monocytogenes total | | | 36 |
| | --- | ATCC 13077 | 10 |
| | --- | ATCC 13090 | 10 |
| | --- | ATCC 13102 | 4 |
| Neisseria meningitidis | --- | ATCC 13103 | 1 |
| | --- | ATCC 35561 | 4 |
| | --- | 6 Individual clinical isolates | 1 each (6) |
| Neisseria meningitidis total | | | 35 |
| | KPC-6 | AR-BANK #0155 | 3 |
| Proteus mirabilis | NDM-1 | AR-BANK #0159 | 3 |
| | CTX-M | Individual clinical isolate | 3 |
| Proteus mirabilis total | 9 | | |
| | VIM-4 | AR-BANK #0054 | 3 |
| | KPC-5 | AR-BANK #0090 | 3 |
| | IMP-14 | AR-BANK #0092 | 4 |
| | VIM-2 | AR-BANK #0100 | 3 |
| Pseudomonas aeruginosa | IMP-1 | AR-BANK #0103 | 4 |
| | VIM-2 | AR-BANK #0108 | 3 |
| | VIM-2 | AR-BANK #0110 | 3 |
| | VIM-2 | AR-BANK #0111 | 3 |
| Pseudomonas aeruginosa total | | | 26 |
| Salmonella sp. | --- | 3 Individual clinical isolates | 3 each (9) |
| Salmonella enterica serogroup C | --- | Individual clinical isolate | 3 |
| Salmonella enterica ser. Berta | --- | Individual clinical isolate | 3 |
| Salmonella enterica ser. Enteritidis | --- | Individual clinical isolate | 3 |
| | mcr-1 | AR-BANK #0496 | 4 |
| Salmonella enterica ser. Javiana | --- | Individual clinical isolate | 3 |
| Salmonella enterica ser. Newport | --- | Individual clinical isolate | 3 |
| Salmonella enterica ser. Senftenberg | NDM-1 | AR-BANK #0127 | 3 |
| Salmonella enterica ser.Typhi | --- | Individual clinical isolate | 3 |
| Salmonella enterica ser. Typhimurium | --- | Individual clinical isolate | 3 |
| Salmonella sp. total | | | 37 |
| Staphylococcus aureus | --- | Individual clinical isolate | 5 |
| Organism | AMR Gene(s) | Strain | Independent Specimens<br>Tested |
| | mecA & MREJ | Individual clinical isolate | 5 |
| Staphylococcus aureus total | | | 10 |
| | --- | 5 Individual clinical isolates | 3 each (15) |
| | --- | ATCC 43809 | 3 |
| Staphylococcus lugdunensis | --- | ATCC 49576 | 3 |
| | --- | ATCC 700328 | 3 |
| | --- | ATCC 700582 | 3 |
| | --- | NCTC 7990 | 3 |
| Staphylococcus lugdunensis total | | | 30 |
| Stenotrophomonas maltophilia | --- | 10 Individual clinical isolates | 3 each (30) |
| Stenotrophomonas maltophilia total | | | 30 |
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
{14}------------------------------------------------
Table 8. Carbapenem AST Results for Strains with Relevant AMR Gene(s) Used in Seeded Specimens
| | | | | Carbapenem AST | | | | |
|----------------------------------------------------------------|----------------|------------------------------------------|----------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--|
| Strain | AMR Gene(s) | Organism | oripene | rtapene | mipene | leropene | ug Not Speci | |
| | | CLSI M100 ED30:2020 Used for Breakpoints | | | | | | |
| Individual clinical isolate | IMP-4 | Acinetobacter baumannii | - | - | S | S | - | |
| Individual clinical isolate | IMP-4 | Escherichia coli | - | R | R | R | - | |
| | | CLSI 2018 M100 S28 Used for Breakpoints | | | | | | |
| AR-BANK #0103 | IMP-1 | Pseudomonas aeruginosa | R | - | R | R | - | |
| AR-BANK #0161 | IMP-4 | Klebsiella aerogenes | R | R | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | - | |
| AR-BANK #0034 | IMP-4 | Klebsiella pneumoniae | l | R | S | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | - | |
| AR-BANK #0080 | IMP-4 | Klebsiella pneumoniae | R | R | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | R | - | |
| AR-BANK #0092 | IMP-14 | Pseudomonas aeruginosa | R | - | R | R | - | |
| AR-BANK #0147 | КРС-3 | Klebsiella oxytoca | -- | R | R | -----------------------------------------------------------…
