Who is the manufacturer of Acuitas AMR Gene Panel?

Opgen, Inc. filed the 510(k) submission for Acuitas AMR Gene Panel (K191288).

What is the FDA product code for Acuitas AMR Gene Panel?

PMY. It is classified under 21 CFR 866.1640 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for Acuitas AMR Gene Panel?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Acuitas AMR Gene Panel?

Cepheid Xpert® Carba-R (K152614).

Who can help prepare an FDA 510(k) submission like Acuitas AMR Gene Panel?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Acuitas AMR Gene Panel

K191288 · Opgen, Inc. · PMY · Sep 30, 2021 · Microbiology

Device Facts

Record ID	K191288
Device Name	Acuitas AMR Gene Panel
Applicant	Opgen, Inc.
Product Code	PMY · Microbiology
Decision Date	Sep 30, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.1640
Device Class	Class 2

Indications for Use

The Acuitas® AMR Gene Panel, performed on the QIAGEN® EZ1® Advanced XL System and the OpGen Qualified QuantStudio™ 5 Real-Time PCR System, is a qualitative nucleic acid-based multiplex in vitro diagnostic test for detection and differentiation of antibiotic resistance markers to one or more antimicrobial agents. The test utilizes real-time polymerase chain reaction (PCR) and is performed on isolated colonies of Pseudomonas aeruginosa, Enterococcus faecalis, or members of Enterobacterales grown in pure culture on blood agar or MacConkey agar. Organism identification results must be available prior to reporting results for the Acuitas AMR Gene Panel. Antimicrobial resistance gene results are reported by the Acuitas AMR Gene Panel for the combinations of bacterial pathogens and associated genetic resistance markers indicated in Table 1 below.

Device Story

Device performs qualitative multiplex real-time PCR to detect 28 genetic resistance markers in isolated bacterial colonies (Enterobacterales, P. aeruginosa, E. faecalis). Workflow: 0.5 McFarland suspension prepared from pure culture; automated DNA extraction on QIAGEN EZ1 Advanced XL; real-time PCR on OpGen Qualified QuantStudio 5. Data exported to Acuitas AMR Gene Analysis Software for report generation. Used in clinical labs by technicians/microbiologists. Output (Detected/Not Detected) aids clinicians in managing resistant infections; results are not prescriptive for specific drugs and do not replace phenotypic susceptibility testing.

Clinical Evidence

Multi-site clinical study (1,307 isolates: 1,224 stock, 83 prospective) compared Acuitas AMR Gene Panel to WGS, MALDI-TOF MS, and broth microdilution AST. PPA for AMR genes ranged from 94.4% to 100%; NPA ranged from 96.5% to 100%.

Technological Characteristics

Nucleic acid-based multiplex real-time PCR. Automated DNA extraction (QIAGEN EZ1 DSP Virus Kit). 96-well PCR plates with dried primers/probes. Connectivity: PC-based analysis software. Software: Rule-based analysis of PCR amplification data.

Indications for Use

Indicated for detection/differentiation of antibiotic resistance markers in isolated colonies of Pseudomonas aeruginosa, Enterococcus faecalis, or Enterobacterales (grown on blood/MacConkey agar) in patients with known/suspected antibiotic-resistant bacterial infections. Requires prior organism identification. Not for use as a substitute for phenotypic antimicrobial susceptibility testing.

Regulatory Classification

Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Predicate Devices

Cepheid Xpert® Carba-R (K152614)

Related Devices

K173263 — Xpert Carba-R · Cepheid · Jan 9, 2018
K152614 — Xpert Carba-R · Cepheid · Mar 7, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. September 30, 2021 OpGen, Inc. % Randy Prebula Partner; Hogan Lovells Hogan Lovells, US LLP Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004 Re: K191288 Trade/Device Name: Acuitas AMR Gene Panel Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: PMY, OOI Dated: October 13, 2020 Received: October 13, 2020 Dear Randy Prebula: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-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, Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility 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) K191288 Device Name Acuitas AMR Gene Panel ### Indications for Use (Describe) The Acuitas® AMR Gene Panel, performed on the QIAGEN® EZ1® Advanced XL System and the OpGen Qualified QuantStudio™ 5 Real-Time PCR System, is a qualitative nucleic acid-based multiplex in vitro diagnostic test for detection and differentiation of antibiotic resistance markers to one or more antimicrobial agents. The test utilizes realtime polymerase chain reaction (PCR) and is performed on isolated colonies of Pseudomonas aeruginosa. Enteroooccus faecalis, or members of Enterobacterales grown in pure culture on blood agar or MacConkey agar. Organism identification results must be available prior to reporting results for the Acuitas AMR Gene Panel. Antimicrobial resistance gene results are reported by the Acuitas AMR Gene Panel for the combinations of bacterial pathogens and associated genetic resistance markers indicated in Table 1 below. [continued on page 2] | 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." {3}------------------------------------------------ # [continued from Form FDA 3881, page 1] | Organism | Reported AMR Gene Marker | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Citrobacter freundii complex a | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Citrobacter koseri | KPC, OXA-48 | | Enterobacter cloacae complex b | CTX-M-1, CTX-M-9, KPC, TEM d | | Enterococcus faecalis | vanA | | Escherichia coli | AAC, ANT, CMY, CTX-M-1, CTX-M-2, CTX-M-9, DFR, gyrA Mutant c, KPC, MCR-1 e, OXA-1, OXA-9, SHV d, Sul1, Sul2, TEM d | | Klebsiella aerogenes | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Klebsiella michiganensis | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Klebsiella oxytoca | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Klebsiella pneumoniae | AAC, AAD, APH, CMY, CTX-M-1, CTX-M-9, DFR, DHA, IMP, KPC, NDM, OXA-1, OXA-9, OXA-48, RMT, Sul1, Sul2, TEM d | | Klebsiella quasipneumoniae | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Klebsiella variicola | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Morganella morganii | CTX-M-1, KPC, NDM, OXA-48 | | Proteus mirabilis | AAC, ANT, APH, armA, CMY, CTX-M-1, CTX-M-2, CTX-M-9, DFR, KPC, NDM, OXA-1, OXA-9, OXA- 48, Sul2, TEM d, VEB, VIM | | Providencia rettgeri | NDM | | Providencia stuartii | NDM | | Pseudomonas aeruginosa | AAC, ANT, CTX-M-1, CTX-M-2, gyrA Mutant c, KPC, NDM, OXA-1, PER, SHV d, TEM d, VEB, VIM | | Raoultella ornithinolytica | KPC, NDM, OXA-48 | | Raoultella planticola | KPC | | Serratia marcescens | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | Table 1 - Antimicrobial Resistance Gene Markers (Genetic Determinants) Associated with Bacterial Species a Citrobacter freundii complex = C. freundii, C. werkmanii and C. youngae. Bnterobacter cloacae complex = E. asburiae, E. cloacae, E. hormaechei, E. kobei and E. ludwigii. ^ PCR assays associated with fluoroquinolone resistance detect and differentiate wild type and mutants of gyraseA at amino acid position 87 for E. coli and position 83 for P. aeruginosa. d PCR assays for SHV and TEM detect sequence variants for the two genes, respectively, at amino acid positions 156 and 104 associated with wild type penicillin resistance and mutations associated with ESBL phenotypes. e The panel includes an assay for the detection of the mobilized colistin genetic determinant MCR-1 in E. coli. The Acuitas AMR Gene Panel includes assays for the detection and reporting of genetic resistance markers associated with resistance to select drugs in the following antibiotic groups: aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, suffonamides, trimethoprim, and vancomycin, to aid in the identification of potentially antimicrobial-resistant organisms. The panel includes an assay for the detection of the mobilized colistin genetic determinant MCR-1, a marker of public health importance associated with reduced inhibitory activity of polymyxins. [continued on page 3] {4}------------------------------------------------ # [continued from page 2] The results of the Acuitas AMR Gene Panel for detection and identification of genetic determinants associated with antimicrobial resistance are used along with the Acuitas AMR Gene Panel Electronic User Guide (EUG). In certain cases, this information may be used as an aid to clinicians in the management of patients with known or suspected antibiotic non-susceptible or resistant bacterial infections. The EUG contains information on the appropriateness of reporting resistance markers detected by the Acuitas AMR Gene Panel for claimed organisms based on the strength of the collective, totality of scientific evidence delineating the level of association between molecular marker detection with phenotypic, clinical resistance. Test results are not conclusive or prescriptive for labeled use of any specific antimicrobial drug product, and therefore, this test cannot be used in place of or to postpone or delay phenotypic antimicrobial susceptibility testing. A "Detected" or "Not Detected" result does not rule out the presence of other antimicrobial resistance markers not detected by the Acuitas AMR Gene Panel. A "Not Detected" result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes, as multiple mechanisms of resistance may exist. {5}------------------------------------------------ # 510(K) SUMMARY # OpGen, Inc. # Acuitas® AMR Gene Panel #### INTRODUCTION l. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. 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. The assigned 510(k) number is K191288. #### A. SUBMITTER OpGen, Inc. 9717 Key West Avenue, Suite 100 Rockville, MD 20850 Phone: 301-869-9683 Fax: 301-869-9684 Email: regulatory@opgen.com Contact Information: Johannes Bacher, Chief Operating Officer OpGen, Inc. 9717 Key West Avenue, Suite 100 Rockville, MD 20850 US Phone: 301-869-9683 Fax: 301-869-9684 Date Prepared: September 29, 2021 #### B. NAME OF DEVICE Acuitas® AMR Gene Panel #### C. COMMON OR USUAL NAME Acuitas AMR Gene Panel {6}------------------------------------------------ #### D. REGULATORY INFORMATION #### 1. Regulation Section: 21 CFR 866.1640 (Antimicrobial susceptibility test powder) #### 2. Classification: Class II #### 3. Product Code: PMY - System, Nucleic Acid Amplification Test, DNA, Carbapenem Non-Susceptible Gram Negative Organism, Colony OOI - Real-time nucleic acid amplification system #### PREDICATE DEVICE ய் The Acuitas AMR Gene Panel is substantially equivalent to the Cepheid Xpert® Carba-R [510(k) # K152614]. #### DEVICE DESCRIPTION ட் The Acuitas® AMR Gene Panel is a qualitative nucleic acid-based in vitro diagnostic test capable of simultaneous detection and identification of select genetic determinants of antimicrobial resistance (AMR) in isolated bacterial colonies grown on blood agar or MacConkey agar. The test detects twenty-eight (28) genetic determinants of resistance to the following nine (9) antibiotic classes: aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, polymyxins, sulfonamides, trimethoprim and vancomycin. The assay is performed on pure colonies of Enterobacterales and Pseudomonas aeruginosa grown on blood agar or MacConkey agar along with Enterococcus faecalis grown on blood agar. The Acuitas AMR Gene Panel kit contains all of the necessary reagents for PCR and detection in order to amplify and detect DNA from pure colonies of Enterobacterales (Citrobacter freundii complex (Citrobacter braakii, Citrobacter freundii, Citrobacter werkmanii, Citrobacter youngae), Citrobacter koseri, Enterobacter cloacae complex (Enterobacter asburiae, Enterobacter cloacae, Enterobacter hormaechei, Enterobacter kobei, Enterobacter ludwigiì), Escherichia coli, Klebsiella pneumoniae, Klebsiella quasipneumoniae, Klebsiella aerogenes, Klebsiella michiganensis, Klebsiella oxytoca, Klebsiella variicola, Morganii, Proteus mirabilis, Providencia rettgeri, Providencia stuartii, Raoultella ornithinolytica, Raoultella planticola, Serratia marcescens) and Pseudomonas aeruginosa grown on blood agar or MacConkey agar, as well as Enterococcus faecalis grown on blood agar from clinical specimens. The test kit includes PCR plates (96-well) with dried primers and probes for analysis of four (4) isolates (24 wells per isolate). The Acuitas AMR Gene Panel assay employs automated deoxyribonucleic acid (DNA) extraction on the QIAGEN® EZ1® Advanced XL System and multiplex real-time PCR on an OpGen Qualified Applied Biosystems™ QuantStudio™ 5 Real-Time PCR System ("OpGen Qualified QuantStudio 5") {7}------------------------------------------------ for use with the Acuitas AMR Gene Panel. The QIAGEN EZ1 DSP Virus Kit has been selected for use as the sample preparation method for the Acuitas AMR Gene Panel test. After colony isolation, the user prepares a 0.5 McFarland suspension for each bacterial isolate and performs DNA extraction. DNA is extracted on the QIAGEN EZ1 Advanced XL System according to manufacturer instructions incorporating the Assay Control within the extraction process. A sample of extracted DNA eluate is transferred to a Reagent Reservoir trough to which Acuitas AMR Gene Panel Master Mix is added. Extracted DNA/Master Mix is transferred to each of 24 wells on the Acuitas AMR Gene Panel PCR plate per test sample. The contents of each well are mixed, and the plate is sealed and transferred to the OpGen Qualified QuantStudio 5 for use with the Acuitas AMR Gene Panel for real-time multiplex reaction and detection using the Acuitas AMR Gene Panel PCR Template File. Data are exported from the OpGen Qualified QuantStudio 5 and imported into the Acuitas AMR Gene Analysis Software, a spreadsheet application that analyzes the data and generates a report for viewing and printing. Each test report indicates detection of applicable antimicrobial resistance gene variants as "Detected", "Not Detected" or "NA/NR". The Applied Biosystems QuantStudio 5 Real-Time PCR System is not intended for clinical diagnostic purposes. The OpGen Qualified QuantStudio 5 for use with the Acuitas AMR Gene Panel is a component of the Acuitas AMR Gene Panel assay and is cleared for in vitro diagnostic use only with the Acuitas AMR Gene Panel and not for any other application. The OpGen Qualified QuantStudio 5 for use with the Acuitas AMR Gene Panel may only be used with the Acuitas AMR Gene Panel after the instrument has been qualified for use by OpGen, Inc. #### G. INTENDED USE / INDICATIONS FOR USE The Acuitas® AMR Gene Panel, performed on the QIAGEN® EZ1® Advanced XL System and the OpGen Qualified QuantStudio™ 5 Real-Time PCR System, is a qualitative nucleic acid-based multiplex in vitro diagnostic test for detection and differentiation of antibiotic resistance markers to one or more antimicrobial agents. The test utilizes real-time polymerase chain reaction (PCR) and is performed on isolated colonies of Pseudomonas aeruginosa, Enterocccus faecalis, or members of Enterobacterales grown in pure culture on blood agar or MacConkey agar. Organism identification results must be available prior to reporting results for the Acuitas AMR Gene Panel. Antimicrobial resistance gene results are reported by the Acuitas AMR Gene Panel for the combinations of bacterial pathogens and associated genetic resistance markers indicated in Table 1 below. | Organism | Reported AMR Gene Marker | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Citrobacter freundii complexa | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Citrobacter koseri | KPC, OXA-48 | | Enterobacter cloacae complexb | CTX-M-1, CTX-M-9, KPC, TEMd | | Enterococcus faecalis | vanA | | Escherichia coli | AAC, ANT, CMY, CTX-M-1, CTX-M-2, CTX-M-9, DFR, gyrA Mutantc, KPC, MCR-1e, OXA-1, OXA-9, SHVd, Sul1, Sul2, TEMd | | Klebsiella aerogenes | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Klebsiella michiganensis | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | Table 1 - Antimicrobial Resistance Gene Markers (Genetic Determinants) Associated with Bacterial Species {8}------------------------------------------------ | Organism | Reported AMR Gene Marker | |----------------------------|----------------------------------------------------------------------------------------------------------------| | Klebsiella oxytoca | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Klebsiella pneumoniae | AAC, AAD, APH, CMY, CTX-M-1, CTX-M-9, DFR, DHA, IMP, KPC, NDM, OXA-1, OXA-9, OXA-48, RMT, Sul1, Sul2, TEMd | | Klebsiella quasipneumoniae | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Klebsiella variicola | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | | Morganella morganii | CTX-M-1, KPC, NDM, OXA-48 | | Proteus mirabilis | AAC, ANT, APH, armA, CMY, CTX-M-1, CTX-M-2, CTX-M-9, DFR, KPC, NDM, OXA-1, OXA-9, OXA-48, Sul2, TEMd, VEB, VIM | | Providencia rettgeri | NDM | | Providencia stuartii | NDM | | Pseudomonas aeruginosa | AAC, ANT, CTX-M-1, CTX-M-2, gyrA Mutantc, KPC, NDM, OXA-1, PER, SHVd, TEMd, VEB, VIM | | Raoultella ornithinolytica | KPC, NDM, OXA-48 | | Raoultella planticola | KPC | | Serratia marcescens | CTX-M-1, CTX-M-9, KPC, NDM, OXA-48 | Citrobacter freundii complex = C. freundii, C. braakii, C. werkmanii and C. youngae. b Enterobacter cloacae complex = E. asburiae, E. cloacae, E. hormaechei, E. kobei and E. ludwigii. & PCR assays associated with fluoroquinolone resistance detect and differentiate wild type and mutants of gyraseA at amino acid position 87 for E. coli and position 83 for P. aeruginosa. d PCR assays for SHV and TEM detect sequence variants for the two genes, respectively, at amino acid positions 156 and 104 associated with wild type penicillin resistance and mutations associated with ESBL phenotypes. ® The panel includes an assay for the detection of the mobilized colistin genetic determinant MCR-1 in E. coli. The Acuitas AMR Gene Panel includes assays for the detection and reporting of genetic resistance markers associated with resistance to select drugs in the following antibiotic groups: aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, sulfonamides, trimethoprim, and vancomycin, to aid in the identification of potentially antimicrobial-resistant organisms. The panel includes an assay for the detection of the mobilized colistin genetic determinant MCR-1, a marker of public health importance associated with reduced inhibitory activity of polymyxins. The results of the Acuitas AMR Gene Panel for detection and identification of genetic determinants associated with antimicrobial resistance are used along with the Acuitas AMR Gene Panel Electronic User Guide (EUG). In certain cases, this information may be used as an aid to clinicians in the management of patients with known or suspected antibiotic non-susceptible or resistant bacterial infections. The EUG contains information on the appropriateness of reporting resistance markers detected by the Acuitas AMR Gene Panel for claimed organisms based on the strength of the collective, totality of scientific evidence delineating the level of association between molecular marker detection with phenotypic, clinical resistance. Test results are not conclusive or prescriptive for labeled use of any specific antimicrobial drug product, and therefore, this test cannot be used in place of or to postpone or delay phenotypic antimicrobial susceptibility testing. A "Detected" or "Not Detected" result does not rule out the presence of other antimicrobial resistance markers not detected by the Acuitas AMR Gene Panel. A "Not Detected" result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes, as multiple mechanisms of resistance may exist. #### H. PREDICATE DEVICE Acuitas AMR Gene Panel assay is substantially equivalent to Cepheid Xpert® Carba-R, [510(k) K152614]. The Acuitas AMR Gene Panel assay and the Xpert Carba-R Assay both detect target gene sequences from antibiotic-resistant bacteria and use real-time PCR amplification and fluorogenic target-specific hybridization detection. {9}------------------------------------------------ The performance characteristics of the Acuitas AMR Gene Panel with bacterial isolates were determined in a multi-site investigational clinical study by comparing the Acuitas AMR Gene Panel to the results of Whole Genome Sequencing (WGS) and Antimicrobial Susceptibility Testing (AST). Table 2 compares the Acuitas AMR Gene Panel to the Cepheid Xpert® Carba-R and outlines the similarities and differences between the two systems. | Item | Proposed Device | Predicate Device | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Sample Types | Acuitas® AMR Gene Panel Bacterial Isolates | Xpert® Carba-R Assay (K152614) Bacterial Isolates | | Organisms Indicated | Enterobacterales, Pseudomonas aeruginosa, and Enterococcus faecalis | Enterobacteriaceae, Acinetobacter baumannii, Pseudomonas aeruginosa | | Assay Targets | AAC, AAD, ANT, APH, armA, CMY, CTX-M-1, CTX-M-2, CTX-M-9, DFR, DHA, E. coli gyrA mutant, IMP, KPC, MCR-1, NDM, OXA-1, OXA-9, OXA-48, P. aeruginosa gyrA mutant, PER, RMT, SHV, Sul1, Sul2, TEM, vanA, VEB and VIM | blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP | | Similarities | | | | Result Types | Qualitative | Same | | Analyte | DNA | Same | | Technological Principles | Automated Nucleic acid amplification (DNA); real-time PCR | Fully automated nucleic acid amplification (DNA); real-time PCR | | Interpretation of Results | Diagnostic software on a Personal Computer (PC) | Same | | Differences | | | | Organism Detected | Enterobacterales, Pseudomonas aeruginosa and Enterococcus faecalis | Enterobacteriaceae, Acinetobacter baumannii, Pseudomonas aeruginosa | | Target Antibiotic Classes | Aminoglycosides, Carbapenems, Cephalosporins, Fluoroquinolones, Penicillins, Polymyxins, Sulfonamides, Trimethoprim, and Vancomycin | Carbapenems | | ltem | Proposed Device | Predicate Device | | | Acuitas® AMR Gene Panel | Xpert® Carba-R Assay (K152614) | | Gene Sequence | AAC, AAD, ANT, APH, armA, CMY, CTX-M-1, CTX-M-2, CTX-M-9, DFR, DHA, E. coli gyrA mutant, IMP, KPC, MCR-1, NDM, OXA-1, OXA-9, OXA-48, P. aeruginosa gyrA mutant, PER, RMT, SHV, Sul1, Sul2, TEM, vanA, VEB and VIM | blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP | | Extraction Method | QIAGEN® EZ1® Advanced XL DNA Extraction | Integrated with GeneXpert® System | | Instrument | OpGen Qualified QuantStudio™ 5 Real-Time PCR System1 | Cepheid GeneXpert® System | | Controls | One Assay Control, External Controls Available | Internal Sample Processing Control (SPC) and Probe Check Control (PCC); External Controls available | | Software | Spreadsheet application which takes output from the OpGen Qualified QuantStudio 5 and generates report on the gene sequence | Automated test report using diagnostic software | | Time to obtain results from start of test | Approximately 2.5 hours | Approximately 50 minutes to results | Table 2 - Comparison of Similarities and Differences of the Acuitas AMR Gene Panel with the Predicate Device {10}------------------------------------------------ ' The Applied Biosystems QuantStudio 5 Real-Time PCR System is not intended for clinical diagnostic purposes. The OpGen Qualified QuantStudio 5 for use with the Acuitas AMR Gene Panel is a component of the Acuitas AMR Gene Panel assay and is cleared for in vitro diagnostic use only with the Acuitas AMR Gene Panel and not for any other application. The OpGen Qualified QuantStudio 5 for use with the Acuitas AMR Gene Panel may only be used with the Acuitas AMR Gene Panel after the instrument has been qualified for use by OpGen, Inc. #### ll. PERFORMANCE DATA #### A. SELECTED NON-CLINICAL STUDIES #### 1. Reproducibility Reproducibility of the Acuitas AMR Gene Panel was evaluated using a panel of 300 uniquely labeled samples composed of ten (10) unique isolates. The panel was provided to three (3) testing sites, one (1) of which was OpGen. The panel was rotated across two (2) operators, two (2) OpGen Qualified QuantStudio 5 instruments and one (1) EZ1 Instrument per site over 20 days. Three (3) unique lots of all materials were used and rotated at each testing site. Overall results for each sample tested in the reproducibility study are summarized in Table 3 - Acuitas AMR Gene Panel Reproducibility of Study Panel – by Isolate. Total agreement per sample (All Sites) ranged from 96% to 100%. {11}------------------------------------------------ | | Site 1 | | | Site 2 | | | | Site 3 | | | | All Sites | |----------------------------------|---------------|---------------|---------------|---------------|----------------|---------------|---------------|---------------|---------------|--|---------------|-----------| | Isolate | Op1 | Op2 | Site 1 | Op1 | Op2 | Site 2 | Op1 | Op2 | Site 3 | | | | | L00000068-001 (E. coli) | 14/15 93% | 15/15 100% | 29/30 97% | 14/15 93% | 14/15 93% | 28/30 93% | 15/15 100% | 14/15 93% | 29/30 97% | | 86/90 96% | | | L00015886-001 (E. coli) | 13/14b 93% | 15/15 100% | 28/29 97% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | | 88/89 99% | | | L00009154-001 (E. coli) | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 14/15 93% | 29/30 97% | 15/15 100% | 15/15 100% | 30/30 100% | | 89/90 99% | | | L00009721-001 (K. pneumoniae) | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 14/15 93% | 29/30 97% | 14/15 93% | 15/15 100% | 29/30 97% | | 88/90 98% | | | L00007800-001 (K. pneumoniae) | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 14/15 93% | 29/30 97% | 15/15 100% | 14/15 93% | 29/30 97% | | 88/90 98% | | | L00008624-001 (P. aeruginosa) | 15/15 100% | 14/15 93% | 29/30 97% | 15/15 100% | 15/15 100% | 30/30 100% | 14/15 93% | 14/15c 93% | 28/30 93% | | 87/90 97% | | | L00013504-001 (P. mirabilis) | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 14/15 93% | 29/30 97% | 15/15 100% | 14/15 93% | 29/30 97% | | 88/90 98% | | | L00013200-001d (P. mirabilis) | 15/15 100% | 15/15 100% | 30/30 100% | 14/15 93% | 14/14e 100% | 28/29 97% | 15/15 100% | 15/15 100% | 30/30 100% | | 88/89 99% | | | L00022926-001 (E. faecalis) | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | | 90/90 100% | | | L00006246-001f (S. aureus) | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 14/15f 93% | 29/30 97% | | 89/90 99% | | Table 3 - Acuitas AMR Gene Panel Reproducibility of Study Panel - by Isolate ª 3 Table includes reported AMR gene results per organism as described in Table 1 along with species ID results for E. coll and P. aeruginosa as used in conjunction with mutant gyrase results for these two organisms. b One replicate of L00015886-001 had invalid results due to an Assay Control Failure. The replicate was repeated using the same lot, instrument, and operator as the original testing event. The repeat data agreed results. Neither initial nor repeat results are reported for this replicate. & Amplification present for P. aeruginosa gyraseA assay called negative P. aeruginosa ID result in one sample. 4 CTX-M-14 (AF252622) was reported by WGS for L00013200-001-300187, which are the correct WGS results for L00013200-001. & One replicate of L00013200-001 had invalid results due to an Assay Control Failure. The replicate was repeated using the same lot, instrument, and operator as the original testing event. The repeat data had 100% agreement with the expected results. Neither initial nor repeat results are reported for this replicate. f The Acuitas AMR Gene Panel is not intended for S. aureus, which served as a negative control in this study. S. aureus was evaluated for all AMR genes in Table 1 except for gyrase gene targets. One replicate sample of L00006246-001 was false positive for the AAC assay. Overall results for each assay target in the reproducibility test panel are summarized in Table 4 -Acuitas AMR Gene Panel Reproducibility of Study Panel - by Gene Target. Total agreement ranged from 97.8% to 100% for detected results and 99.4% to 100% for not detected results across the individual assay targets. {12}------------------------------------------------ | Acuitas AMR Gene Target | Expected Results | Site 1 | | | Site 2 | | | Site 3 | | | Total % Agreement by Target | |---------------------------------------------------------|---------------------|-----------------|-----------------|------------------|-----------------|-----------------|------------------|-----------------|------------------|------------------|-----------------------------------| | AAC | Detected | 60/60 100% | 60/60 100% | 120/120 100% | 60/60 100% | 59/59 100% | 119/119 100% | 60/60 100% | 60/60 100% | 120/120 100% | 359/359 100% | | AAC | Not Detected | 74/74 100% | 75/75 100% | 149/149 100% | 75/75 100% | 75/75 100% | 150/150 100% | 75/75 100% | 74/75 d 98.7% | 149/150 99.3% | 448/449 99.80% | | AAD | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | AAD | Not Detected | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 180/180 100% | | ANT | Detected | 30/30 100% | 30/30 100% | 60/60 100% | 29/30 96.7% | 30/30 100% | 59/60 98.30% | 30/30 100% | 28/30 93.3% | 58/60 96.7% | 177/180 98.30% | | ANT | Not Detected | 74/74 100% | 75/75 100% | 149/149 100% | 75/75 100% | 73/74 98.6% | 148/149 99.3% | 74/75 98.7% | 75/75 100% | 149/150 99.3% | 446/448 99.60% | | APH | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 14/14 100% | 29/29 100% | 15/15 100% | 15/15 100% | 30/30 100% | 89/89 100% | | APH | Not Detected | 60/60 100% | 60/60 100% | 120/120 100% | 60/60 100% | 60/60 100% | 120/120 100% | 60/60 100% | 60/60 100% | 120/120 100% | 360/360 100% | | armA | Detected e | - | - | - | - | - | - | - | - | - | | | armA | Not Detected | 45/45 100% | 45/45 100% | 90/90 100% | 45/45 100% | 44/44 100% | 89/89 100% | 45/45 100% | 45/45 100% | 90/90 100% | 269/269 100% | | CMY | Detected | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 180/180 100% | | CMY | Not Detected | 88/89 98.9% | 90/90 100% | 178/179 99.4% | 90/90 100% | 89/89 100% | 179/179 100% | 90/90 100% | 90/90 100% | 180/180 100% | 537/538 99.80% | | CTX-M-1 | Detected | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 180/180 100% | | CTX-M-1 | Not Detected | 104/104 100% | 105/105 100% | 209/209 100% | 105/105 100% | 104/104 100% | 209/209 100% | 105/105 100% | 105/105 100% | 210/210 100% | 628/628 100% | | CTX-M-2 | Detected e | - | - | - | - | - | - | - | - | - | | | CTX-M-2 | Not Detected | 104/104 100% | 105/105 100% | 209/209 100% | 105/105 100% | 104/104 100% | 209/209 100% | 105/105 100% | 105/105 100% | 210/210 100% | 628/628 100% | | CTX-M-9 | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 14/14 100% | 29/29 100% | 15/15 100% | 15/15 100% | 30/30 100% | 89/89 100% | | CTX-M-9 | Not Detected | 104/104 100% | 105/105 100% | 209/209 100% | 105/105 100% | 104/105 99% | 209/210 99.5% | 105/105 100% | 105/105 100% | 210/210 100% | 628/629 99.80% | | DFR | Detected | 45/45 100% | 45/45 100% | 90/90 100% | 45/45 100% | 44/44 100% | 89/89 100% | 45/45 100% | 45/45 100% | 90/90 100% | 269/269 100% | | DFR | Not Detected | 74/74 100% | 75/75 100% | 149/149 100% | 75/75 100% | 75/75 100% | 150/150 100% | 75/75 100% | 75/75 100% | 150/150 100% | 449/449 100% | | DHA | Detected e | - | - | - | - | - | - | - | - | - | | | Acuitas AMR | Expected | Site 1 | | | Site 2 | | | Site 3 | | | Total % | | Gene Target | Results | Op 1 a | Op 2 | Site | Op 1 | Op 2 b | Site | Op 1 | Op 2 | Site | Agreement by Target | | | Not Detected | 45/45 100% | 45/45 100% | 90/90 100% | 45/45 100% | 45/45 100% | 90/90 100% | 45/45 100% | 45/45 100% | 90/90 100% | 270/270 100% | | E. coli gyrA Mutant | Detected | 14/15 93.3% | 15/15 100% | 29/30 96.7% | 15/15 100% | 14/15 93.3% | 29/30 96.70% | 15/15 100% | 15/15 100% | 30/30 100% | 88/90 97.80% | | | Not Detected | 29/29 100% | 30/30 100% | 59/59 100% | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 179/179 100% | | E. coli ID | Detected | 44/44 100% | 45/45 100% | 89/89 100% | 45/45 100% | 44/45 97.8% | 89/90 98.9% | 45/45 100% | 45/45 100% | 90/90 100% | 268/269 99.6% | | | Not Detected e | - | - | - | - | - | - | - | - | - | - | | IMP | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | | Not Detected | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 29/30 96.7% | 30/30 100% | 59/60 98.3% | 179/180 99.40% | | KPC | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | | Not Detected | 119/119 100% | 120/120 100% | 239/239 100% | 120/120 100% | 119/119 100% | 239/239 100% | 120/120 100% | 120/120 100% | 240/240 100% | 718/718 100% | | | Detected e | - | - | - | - | - | - | - | - | - | - | | MCR-1 | Not Detected | 59/59 100% | 60/60 100% | 119/119 100% | 60/60 100% | 60/60 100% | 120/120 100% | 60/60 100% | 60/60 100% | 120/120 100% | 359/359 100% | | | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | NDM | Not Detected | 75/75 100% | 75/75 100% | 150/150 100% | 75/75 100% | 74/74 100% | 149/149 100% | 75/75 100% | 75/75 100% | 150/150 100% | 449/449 100% | | | Detected | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 29/29 100% | 59/59 100% | 30/30 100% | 30/30 100% | 60/60 100% | 179/179 100% | | OXA-1 | Not Detected | 104/104 100% | 105/105 100% | 209/209 100% | 105/105 100% | 105/105 100% | 210/210 100% | 105/105 100% | 105/105 100% | 210/210 100% | 629/629 100% | | | Detected e | - | - | - | - | - | - | - | - | - | - | | OXA-9 | Not Detected | 119/119 100% | 120/120 100% | 239/239 100% | 120/120 100% | 119/119 100% | 239/239 100% | 120/120 100% | 120/120 100% | 240/240 100% | 718/718 100% | | | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | OXA-48 | Not Detected | 60/60 100% | 60/60 100% | 120/120 100% | 59/60 98.3% | 59/59 100% | 118/119 99.2% | 60/60 100% | 60/60 100% | 120/120 100% | 358/359 99.70% | | P. aeruginosa gyrA Mutant | Detected | 15/15 100% | 14/15 93.3% | 29/30 96.7% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 14/15 93.3% | 29/30 96.7% | 88/90 97.80% | | | Not Detected e | - | - | - | - | - | - | - | - | - | - | | Acuitas AMR Gene Target | Expected Results | Site 1 | | | Site 2 | | | Site 3 | | | Total % Agreement by Target | | | | Op 1 a | Op 2 | Site | Op 1 | Op 2 b | Site | Op 1 | Op 2 | Site | | | P. aeruginosa ID | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 14/15 93.3% | 29/30 96.7% | 89/90 98.9% | | | Not Detected e | - | - | - | - | - | - | - | - | - | - | | PER | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | | Not Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | | Detected e | - | - | - | - | - | - | - | - | - | - | | RMT | Not Detected | 45/45 100% | 45/45 100% | 90/90 100% | 45/45 100% | 45/45 100% | 90/90 100% | 45/45 100% | 45/45 100% | 90/90 100% | 270/270 100% | | | Detected e | - | - | - | - | - | - | - | - | - | - | | SHV | Not Detected | 74/74 100% | 75/75 100% | 149/149 100% | 75/75 100% | 75/75 100% | 150/150 100% | 75/75 100% | 75/75 100% | 150/150 100% | 449/449 100% | | | Detected | 60/60 100% | 60/60 100% | 120/120 100% | 60/60 100% | 60/60 100% | 120/120 100% | 60/60 100% | 60/60 100% | 120/120 100% | 360/360 100% | | Sul1 | Not Detected | 29/29 100% | 30/30 100% | 59/59 100% | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 179/179 100% | | | Detected | 104/104 100% | 105/105 100% | 209/209 100% | 105/105 100% | 103/104 99% | 208/209 99.5% | 105/105 100% | 105/105 100% | 210/210 100% | 627/628 99.80% | | Sul2 | Not Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | | Detected | 104/104 100% | 105/105 100% | 209/209 100% | 105/105 100% | 103/104 99% | 208/209 99.5% | 105/105 100% | 105/105 100% | 210/210 100% | 627/628 99.80% | | TEM | Not Detected | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 30/30 100% | 30/30 100% | 60/60 100% | 180/180 100% | | | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | vanA | Not Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | VEB | Not Detected | 45/45 100% | 45/45 100% | 90/90 100% | 45/45 100% | 44/44 100% | 89/89 100% | 45/45 100% | 45/45 100% | 90/90 100% | 269/269 100% | | | Detected | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 15/15 100% | 15/15 100% | 30/30 100% | 90/90 100% | | VIM | Not Detected | 45/45 100% | 45/45 100% | 90/90 100% | 45/45 100% | 44/44 100% | 89/89 100% | 45/45 100% | 45/45 100% | 90/90 100% | 269/269 100% | Table 4 - Acuitas AMR Gene Panel Reproducibility of Study Panel - by Gene Target • {13}------------------------------------------------ {14}------------------------------------------------ 3 One replicate of L00015886-001 had invalid results due to an Assay Control Failure. The replicate was repeated using the same lot, instrument, and operator as the original testing event. The repeat data had 100% agreement with the initial nor repeat results are reported for this replicate. * One replicate of L00013200-001 had invalid results due to an Assay Control Failure. The replicate was repeated using the same lot, instrument, and operator as the original testing event. The repeat data had 100% agreement with the initial nor repeat results are reported for this replicate. · Amplification present for P. aeruginosa gyraseA assay called negative P. aeruginosa ID result in one sample. {15}------------------------------------------------ f Organism ID only utilized in the context of gyrA mutant detection. #### 2. Analytical Reactivity (Inclusivity) The analytical sensitivity of the Acuitas AMR Gene Panel was evaluated by testing a panel of two hundred and ninety-eight (298) isolates covering all antimicrobial resistance genes detected by the Acuitas AMR Gene Panel test. Each isolate in the test panel was tested once, except for isolates harboring rare resistance genes, which were replicated to achieve at least 18 positive data points per gene target assessed. The Acuitas AMR Gene Panel results were compared with species identification by well-established automated species identification methods and AMR gene detection by Whole Genome Sequencing (WGS). Table 5 - Analytical Reactivity (Inclusivity) Results summarizes AMR genes detected or not detected by Acuitas AMR Gene Panel. Table 5 also indicates AMR gene variants predicted to be detected by in silico analysis but not tested in this study. | | | | Acuitas AMR Gene Panel | | | | |----------|--------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | AMR Gene | Number of Samples Positive for Gene by WGS | Number of Unique Isolates Positive for Gene by WGS | AMR Gene(s) Detected | AMR Gene(s) Not Detected | Other AMR Gene Variants Predicted to be Detected by Acuitas AMR Gene Panel Based on In Silico Analysisd | | | AAC | 198 | 162 | aac(3)-Ila, aac(3)-Ild, aac(3)-IVa, aac(6')-lb, aac(6')Ib-cr, aacA4-8, aacA4 | | Detectable: aac(3)-IIc, aac(3)-Ile, aac(3)-Ib-aac(6')-Ib, ant(3")-Ih-aac(6')-Ild | | | AAD | 70 | 62 | aadA1, aadA2 | | Detectable: aadA13, aadA3, aadA8, aadA8b, aadA7b, aadA17 Likely Detectable: aadA12, aadA21, aadA22, aadA23 | | | ANT | 63 | 40 | aadB | | - | | | APH | 15 | 14 | aph(4)-la | aph(4)- la V01499 | - | | | armA | 1 | 1 | armA | | - | | | CMY | 26 | 25 | blaCMY-16, blaCMY-2, blaCMY-4, blaCMY-42, blaCMY-6, blaCMY-60 | blaCMY- 16_FJ855437 | Detectable: blaBIL-1, blaCMY-0, blaCMY-102, blaCMY- 108, blaCMY-110, blaCMY-111, blaCMY-112, blaCMY- 113, blaCMY-114, blaCMY-115, blaCMY-118, blaCMY- 12, blaCMY-14, blaCMY-15, blaCMY-17, blaCMY-18, blaCMY-20, blaCMY-21, blaCMY-22, blaCMY-23, blaCMY-24, blaCMY-25, blaCMY-27, blaCMY-28, blaCMY-29, blaCMY-3, blaCMY-30, blaCMY-31, blaCMY-32, blaCMY-33, blaCMY-34, blaCMY-35, blaCMY-36, blaCMY-38, blaCMY-39, blaCMY-41, blaCMY-43, blaCMY-44, blaCMY-45, blaCMY-47, blaCMY-48, blaCMY-5, blaCMY-50, blaCMY-51, blaCMY-54, blaCMY-55, blaCMY-56, blaCMY-57, blaCMY-58, blaCMY-59, blaCMY-61, blaCMY-62, blaCMY-63, blaCMY-65, blaCMY-66, blaCMY-67, blaCMY-68, blaCMY-69, blaCMY-7, blaCMY-71, blaCMY-72, blaCMY-75, blaCMY-76, blaCMY-77, blaCMY-78, blaCMY-80, blaCMY-81, blaCMY-84, blaCMY-87, blaCMY-90, blaCMY-94,…

Acuitas AMR Gene Panel

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Acuitas AMR Gene Panel

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!