(451 days)
Not Found
No
The description focuses on automated physical processes (lysis, centrifugation, optical density measurements) and software for workflow guidance and data management. There is no mention of AI or ML being used for analysis, interpretation, or decision-making within the device's core function.
No
The device is an automated inoculum preparation system used for in vitro antimicrobial susceptibility testing, which is a diagnostic purpose, not a therapeutic one.
Yes
The device prepares a McFarland-equivalent suspension for quantitative in vitro antimicrobial susceptibility testing, which provides information on how effective antimicrobials are against specific bacteria. This process is used to diagnose susceptibility or resistance to antimicrobial agents.
No
The device description explicitly states that the PBC Separator with Selux AST System is an "automated sample preparation instrument with associated consumables" and includes components like a "sample prep station (i.e., AST Workbench), an Inoculator, an Analyzer, Workbench Computer". This indicates the presence of significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is used for "quantitative in vitro antimicrobial susceptibility testing." The term "in vitro" is a key indicator of an IVD.
- Sample Type: The device processes "positive blood culture samples," which are biological specimens taken from a patient.
- Purpose: The purpose is to prepare an inoculum for antimicrobial susceptibility testing, which is a diagnostic test performed outside the body to determine how effective different antibiotics are against a specific microorganism. This information is used to guide patient treatment.
- Device Description: The description details an automated sample preparation instrument and associated consumables used to prepare a sample for AST testing.
- Performance Studies: The document describes clinical performance testing comparing the device's results to a reference method (broth microdilution), which is standard practice for evaluating IVDs. The metrics used (Essential Agreement, Category Agreement, Errors) are also typical for evaluating the performance of diagnostic tests.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K231536; eQUANT System) strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
In summary, the device's intended use, the type of sample it processes, its purpose in preparing a sample for a diagnostic test, and the nature of the performance studies all point to it being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PBC Separator with Selux AST System is an automated inoculum preparation system that uses lysis, centrifygation and sequential optical density measurements to generate a McFarland-equivalent suspension from positive blood culture samples that can be used for quantitative in vitro antimicrobial susceptibility testing by the Selux AST System. Samples are processed directly from blood culture samples identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial, gram negative rods by Gram stain. Organism identification is required for AST result interpretation and reporting, per the Selux AST System instructions for use.
Inoculum preparation by the PBC Separator was evaluated for use with the Selux AST System. Performance was demonstrated for the antimicrobial agents and organisms identified below:
Amikacin: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa Amoxicillin-Clavulanate: Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Proteus mirabilis, Proteus vulgaris
Ampicillin: Escherichia coli, Proteus mirabilis
Ampicillin-Sulbactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis
Cefazolin: Escherichia coli, Klebsiella pneumoniae
Cefepime: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Ceftazidime: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa
Ceftazidime-Avibactam: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Ceftriaxone: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens
Ciprofloxacin: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Ertapenem: Citrobacter freundii complex, Cirobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens
Gentamicin: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Imipenem: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae
Meropenem: Acinetobacter baumannii complex, Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Minocycline: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae
Piperacillin-Tazobactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Tobramycin: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa
Susceptibility test results are intended to be used in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing as needed. Additionally, subculture of positive is necessary for the susceptibility testing of organisms present in polymicrobial samples, for testing antimicrobial agents and species not indicated for testing with the device, for epidemiologic testing, and for recovery of organisms present in microbial samples.
Product codes (comma separated list FDA assigned to the subject device)
QZX, LON, LTT, LTW
Device Description
The Positive Blood Culture (PBC) Separator with Selux AST System is an automated sample preparation instrument with associated consumables that uses lysis, centrifugation, and sequential optical density measurements to prepare a tuned McFarland-equivalent inoculum from positive blood culture bottles that have rung positive on a continuous monitoring blood culture system. Inoculums containing monomicrobial, gram negative bacteria are used for AST processing with the Selux AST System. The Selux AST System includes a sample prep station (i.e., AST Workbench), an Inoculator, an Analyzer, Workbench Computer, and the reagents and consumables required to perform AST testing. The PBC Separator and all Selux AST System components are connected to a site workstation, which coordinates sample processing on all instruments. The PBC Separator contains embedded software and a graphical user interface that guides users through the PBC Separator workflow. Once processing of the PBC sample is complete, the user transfers the tuned McFarland inoculum to the Selux AST System for further AST processing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical performance testing with the PBC Separator with Selux AST System was performed at four test sites using fresh positive blood culture samples left over from routine clinical care and seeded samples. Seeded samples were prepared using banked frozen isolates seeded at 10-10,000 CFU into blood culture bottles together with approximately 10 mL of fresh human blood from a healthy donor and then loaded into an FDA-cleared continuous monitoring blood culture system until positive growth was detected. Positive blood bottles were tested with the PBC Separator and Selux AST System. Fresh positive blood culture samples were collected from two clinical sites serving all boroughs of New York City and seeded samples were chosen to represent geographic diversity across the continental U.S. A total of 469 clinical (162 fresh and 307 seeded) and 87 challenge isolates from 12 Enterobacterales species, Acinetobacter baumannii complex, and Pseudomonas aeruginosa were tested to evaluate the PBC Separator performance for 17 antimicrobials with the Selux AST System. Depending on the spectrum of activity, breakpoints, and the claimed organisms (species/group) for each antimicrobial on the panel, the number of datapoints for the various antimicrobial-organisms tested varied and ranged from 38 (e.g. A. baumannii/Amikacin) to 469 (e.g. Enterobacterales/Ciprofloxacin).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reproducibility Study:
Intra- and inter-site reproducibility was evaluated.
Intra-site N: 45 to 63 samples per antimicrobial.
Inter-site N: 135 to 189 samples per antimicrobial.
Key results:
Intra-Site Reproducibility: Best-Case and Worst-Case reproducibility was ≥ 95%.
Inter-Site Reproducibility: Best-Case and Worst-Case reproducibility was > 95%.
Other Analytical Studies:
-
Post-Positivity Sample Stability Study:
Comparison of MIC results from samples processed at t=0 hr and t=16 hr post-positivity.
Key results: Essential agreement (EA) >95% for every antimicrobial agent at the 16-hour timepoint compared with the 0-hour timepoint. Total EA for all results was 99.6% (264/265 results in EA). -
Blood Culture Bottle Compatibility Study:
Evaluated 11 types of blood culture bottles (BD BACTEC, bioMerieux BacT/ALERT systems).
Bacterial samples seeded at clinically relevant concentrations.
Key results:
Across all aerobic bottle types, there was 99.3% EA (1629/1640 results in EA), and each aerobic bottle type had EA ≥ 98.5%.
Across all anaerobic bottle types, there was 99.5% EA (974/979 results in EA), and each anaerobic bottle type had EA ≥ 98.5%.
Note: Ciprofloxacin tested with Enterobacterales from bioMérieux BacT/ALERT SA bottles demonstrated an EA 89.9% EA for every interferent tested compared with control conditions.
Note: An essential agreement
§ 866.1650 A cellular analysis system for multiplexed antimicrobial susceptibility testing.
(a)
Identification. A cellular analysis system for multiplexed antimicrobial susceptibility testing is a multiplex qualitative and/or quantitative in vitro diagnostic device intended for the identification and determination of the antimicrobial susceptibility results of organisms detected in samples from patients with suspected microbial infections. This device is intended to aid in the determination of antimicrobial susceptibility or resistance when used in conjunction with other laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) Detailed device description documentation, including the device components, ancillary reagents required but not provided, a detailed explanation of the methodology, including primer/probe sequence, design, rationale for sequence selection, and details of the antimicrobial agents, as applicable.
(ii) Detailed documentation from the following analytical and clinical performance studies: limit of detection, inclusivity, precision, reproducibility, interference, cross-reactivity, carryover, and cross-contamination, quality control and additional studies, as applicable to specimen type and assay intended use.
(iii) Detailed documentation from an appropriate clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods.
(iv) Detailed documentation for device software, including software applications and hardware-based devices that incorporate software.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) Limitations and protocols regarding the need for correlation of results by standard laboratory procedures, as applicable.
(ii) A detailed explanation of the interpretation of results and acceptance criteria.
(iii) A detailed explanation of the principles of operation and procedures for assay performance and troubleshooting.
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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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 8, 2024
Selux Diagnostics, Inc Carrene Plummer VP, Regulatory and Quality 56 Roland Street, Suite 206 Charlestown, MA, 02129
Re: K223493
Trade/Device Name: PBC Separator with Selux AST System Regulation Number: 21 CFR 866.1650 Regulation Name: A cellular analysis system for multiplexed antimicrobial susceptibility Regulatory Class: Class II Product Code: QZX, LON, LTT, LTW
Dear Carrene Plummer:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 15, 2024. Specifically, FDA is updating this SE Letter as an administrative correction to include all cleared drugorganism combinations in your Indications for Use.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Patrick Axtell, Ph.D., ORP: Office of Regulatory Programs, 301-796-6462, patrick.axtell(@fda.hhs.gov.
Sincerely.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief, General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/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, "U.S. Food & Drug Administration," written out next to it.
February 15, 2024
Selux Diagnostics, Inc % Carrene Plummer Senior Director, Regulatory Affairs PBO Consulting 2212 East Pratt Street Baltimore, Maryland 21231
Re: K223493
Trade/Device Name: PBC Separator Regulation Number: 21 CFR 866.1650 Regulation Name: A Cellular Analysis System For Multiplexed Antimicrobial Susceptibility Regulatory Class: Class II Product Code: OZX, LON, LTT, LTW Dated: January 23, 2024 Received: January 23, 2024
Dear Carrene Plummer:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief, General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K223493
Device Name PBC Separator with Selux AST System
Indications for Use (Describe)
The PBC Separator with Selux AST System is an automated inoculum preparation system that uses lysis, centrifygation and sequential optical density measurements to generate a McFarland-equivalent suspension from positive blood culture samples that can be used for quantitative in vitro antimicrobial susceptibility testing by the Selux AST System. Samples are processed directly from blood culture samples identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial, gram negative rods by Gram stain. Organism identification is required for AST result interpretation and reporting, per the Selux AST System instructions for use.
Inoculum preparation by the PBC Separator was evaluated for use with the Selux AST System. Performance was demonstrated for the antimicrobial agents and organisms identified below:
Amikacin: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa Amoxicillin-Clavulanate: Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Proteus mirabilis, Proteus vulgaris
Ampicillin: Escherichia coli, Proteus mirabilis
Ampicillin-Sulbactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis
Cefazolin: Escherichia coli, Klebsiella pneumoniae
Cefepime: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Ceftazidime: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa
Ceftazidime-Avibactam: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Ceftriaxone: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens
Ciprofloxacin: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Ertapenem: Citrobacter freundii complex, Cirobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens
Gentamicin: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Imipenem: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae
Meropenem: Acinetobacter baumannii complex, Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Minocycline: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae
Piperacillin-Tazobactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Tobramycin: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa
4
Susceptibility test results are intended to be used in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing as needed. Additionally, subculture of positive is necessary for the susceptibility testing of organisms present in polymicrobial samples, for testing antimicrobial agents and species not indicated for testing with the device, for epidemiologic testing, and for recovery of organisms present in microbial samples.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for the PBC Separator with Selux AST System
Date prepared: June 28, 2024
Submitter:
Selux Diagnostics, Inc. 56 Roland St Suite 106 Charlestown, MA 02129 Tel. 617-945-9383
Contact:
Carrene Plummer Tel. 520-405-1462
Subject Device
| Trade Name: | PBC Separator with Selux AST System |
|---|---|
| Common Name: | Antimicrobial Susceptibility Test System |
| Regulation Number: | 21 CFR 866.1650 |
| Regulation Name: | Positive Blood Culture Processor For Inoculum Preparation Used for |
| Antimicrobial Susceptibility Testing | |
| Regulatory Class: | Class II |
| Product Code: | QZX, LON, LTT, LTW |
| Classification Panel: | 83 (Microbiology) |
Predicate Device
| Trade Name: | eQUANT System |
|---|---|
| Manufacturer: | Avails Medical, Inc. |
| 510(k) Reference: | K231536 |
| Common Name: | eQUANT System |
| Regulation Number: | 21 CFR 866.1650 |
| Regulation Name: | Positive Blood Culture Identification and AST Kit |
| Regulatory Class: | Class II |
| Product Code: | QZX, JTN |
| Classification Panel: | 83 (Microbiology) |
Device Description
The Positive Blood Culture (PBC) Separator with Selux AST System is an automated sample preparation instrument with associated consumables that uses lysis, centrifugation, and sequential optical density measurements to prepare a tuned McFarland-equivalent inoculum from positive blood culture bottles that have rung positive on a continuous monitoring blood culture system. Inoculums containing monomicrobial, gram negative bacteria are used for AST processing with the Selux AST System. The Selux AST System includes a sample prep station (i.e., AST Workbench), an Inoculator, an Analyzer, Workbench Computer, and the reagents and consumables required to perform AST testing. The PBC Separator and all Selux AST System components are connected to a site workstation, which coordinates sample processing on all instruments. The PBC Separator contains embedded software and a graphical user interface that guides users through the
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PBC Separator workflow. Once processing of the PBC sample is complete, the user transfers the tuned McFarland inoculum to the Selux AST System for further AST processing.
The PBC Separator with Selux AST System can only provide AST results for monomicrobial samples. Since the PBC Separator with Selux AST System do not perform identification (ID), the monomicrobial nature of the sample under test must be confirmed by an FDA-cleared direct-frompositive blood culture ID system.
While PBC Separator processing can be performed without species-level ID, this information is required for the Selux AST System to interpret and report susceptibility results. Species ID can be performed by any appropriate method and this information can be either manually input to the Selux AST System or automatically downloaded from the laboratory information system (LIS) at any time, once the sample ID is entered into the LIS.
The PBC Separator with the Selux AST System utilizes the Selux Gram Negative Panel, a 384well panel that provides parallel results for the antimicrobials indicated for each sample type. The Selux AST System software masks non-indicated results. The average time-to-result for positive blood culture processed with the PBC Separator and Selux AST System is under 7 hours.
Principle of Operation
The PBC Separator automatically prepares a tuned bacterial inoculum directly from a blood culture bottle sample that "rang" positive on an FDA-cleared continuous monitoring blood culture system, including the Becton Dickinson BACTEC, the bioMerieux BacT/Alert 3D, and the bioMerieux Virtuo. The PBC Separator removes contaminants through repeated centrifugation-wash cycles and specific chemical lysis of mammalian cells and cell fragments. The PBC Separator utilizes an on-board spectrometer to tune the inoculum for the right cell density to perform AST.
Tuned inoculums are used with the Selux AST System. The Selux AST System performs AST similarly to the reference broth microdilution method by first incubating samples, then quantifying microbial growth in each well of an antimicrobial dilution series after a growth period, and finally determining the minimum inhibitory concentration (MIC) by comparing growth data in each well.
AST testing of PBC samples requires that the Gram type (classification) of the organism be known prior to testing on the Selux AST System as the information is necessary to select the proper AST panel to use. Organism identification (ID) is not needed to initiate testing with the Selux AST System. However, the organism ID is necessary for a result to be interpreted and reported because the MIC-determining algorithm is species-specific as is the interpretative Susceptible, Intermediate, or Resistant (SIR) determination. Any FDA-cleared method may be used to provide an ID including biochemical techniques, matrix-assisted laser desorption/isotherm mass spectrometry, and multiplex genetic assays.
Intended Use and Indications for Use
The Selux AST System is intended to be used for the automated quantitative or qualitative susceptibility testing for most clinically significant aerobic microorganisms. The Selux AST System does not provide organism identification.
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Indications for Use
The PBC Separator with the Selux AST System is an automated inoculum preparation system that uses lysis, centrifugation and sequential optical density measurements to generate a McFarlandequivalent suspension from positive blood culture samples that can be used for quantitative in vitro antimicrobial susceptibility testing by the Selux AST System. Samples are processed directly from blood culture samples identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial, gram negative rods by Gram stain. Organism identification is required for AST result interpretation and reporting, per the Selux AST System instructions for use.
Inoculum preparation by the PBC Separator was evaluated for use with the Selux AST System and the Selux Gram Negative Panel. Performance was demonstrated for the antimicrobial agents and organisms identified below:
Amikacin: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa
Amoxicillin-Clavulanate: Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Proteus mirabilis, Proteus vulgaris
Ampicillin: Escherichia coli, Proteus mirabilis
Ampicillin-Sulbactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis
Cefazolin: Escherichia coli, Klebsiella pneumoniae
Cefepime: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Ceftazidime: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa
Ceftazidime-Avibactam: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Ceftriaxone: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens
Ciprofloxacin: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Ertapenem: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens
Gentamicin: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Imipenem: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae
Meropenem: Acinetobacter baumannii complex, Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella
8
pneumoniae, Morganella morganii. Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Minocycline: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae
Piperacillin-Tazobactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa
Tobramycin: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa
Susceptibility test results are intended to be used in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing as needed. Additionally, subculture of positive blood culture is necessary for the susceptibility testing of organisms present in polymicrobial samples, for testing antimicrobial agents and species not indicated for testing with the device, for epidemiologic testing, and for recovery of organisms present in microbial samples.
Comparison of Technological Characteristics with the Predicate and Reference Devices
The technological characteristics of the PBC Separator are substantially equivalent to the primary predicate device, the eQUANT System (K231536) in terms of intended use, application, user population, basic design, performance, and labeling.
| Device & Predicate
Devices: | K223494
Device | K231536
Predicate |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | PBC Separator with Selux AST
System | eQUANT System |
| Device Characteristics | The PBC Separator with the Selux
AST System is an automated
inoculum preparation system that uses
lysis, centrifugation and sequential
optical density measurements to
generate a McFarland-equivalent
suspension from positive blood
culture samples that can be used for
quantitative in vitro antimicrobial
susceptibility testing by the Selux
AST System. Samples are processed
directly from blood culture samples
identified as positive by a continuous
monitoring blood culture system.
Samples should be confirmed as
monomicrobial, gram negative rods
by Gram stain. Organism
identification is required for AST
result interpretation and reporting, per
the Selux AST System instructions for
use. | The eQUANT™ System is an
automated inoculum preparation system
that uses potentiometric sensing of
oxidation-reduction potential changes
due to pathogen metabolism to generate
a 0.5 McFarland equivalent suspension
(the eMcFarland or eMcF) from positive
blood culture samples that can be used
for direct, qualitative in vitro
susceptibility testing by the agar disk
diffusion test method (Kirby-Bauer).
Samples are processed directly from
blood culture samples identified as
positive by a continuous monitoring
blood culture system and confirmed as
Gram-negative rods by Gram stain.
Organism identification must be
confirmed by an FDA cleared device for
direct testing from positive blood
culture before processing samples on
the eQUANT™ System. |
| Indication for Use | | |
| Device & Predicate
Devices: | K223494
Device | K231536
Predicate |
| Source of
Microorganisms | bacteria from positive blood cultures | Same |
| Indicated
Antimicrobial/Organism
Combinations | Amikacin: Acinetobacter baumannii
complex, Escherichia coli, Klebsiella
pneumoniae, Pseudomonas
aeruginosa
Amoxicillin-Clavulanate:
Escherichia coli, Klebsiella species
(including K. oxytoca, K.
pneumoniae), Proteus mirabilis,
Proteus vulgaris
Ampicillin: Escherichia coli, Proteus
mirabilis
Ampicillin-Sulbactam:
Acinetobacter baumannii complex,
Citrobacter koseri, Escherichia coli,
Klebsiella pneumoniae, Proteus
mirabilis
Cefazolin: Escherichia coli,
Klebsiella pneumoniae
Cefepime: Citrobacter freundii
complex, Citrobacter koseri,
Enterobacter cloacae complex,
Escherichia coli, Klebsiella
aerogenes, Klebsiella oxytoca,
Klebsiella pneumoniae, Morganella
morganii, Proteus mirabilis, Proteus
vulgaris, Serratia marcescens,
Pseudomonas aeruginosa
Ceftazidime: Escherichia coli,
Klebsiella pneumoniae, Pseudomonas
aeruginosa
Ceftazidime-Avibactam: Citrobacter
freundii complex, Citrobacter koseri,
Enterobacter cloacae complex,
Escherichia coli, Klebsiella
aerogenes, Klebsiella oxytoca,
Klebsiella pneumoniae, Morganella
morganii, Proteus mirabilis, Proteus
vulgaris, Serratia marcescens,
Pseudomonas aeruginosa
Ceftriaxone: Citrobacter freundii
complex, Citrobacter koseri,
Enterobacter cloacae complex,
Escherichia coli, Klebsiella
aerogenes, Klebsiella oxytoca,
Klebsiella pneumoniae, Proteus
mirabilis | Amoxicillin/clavulanate: Escherichia
coli, Klebsiella oxytoca, Klebsiella
pneumoniae, Proteus mirabilis
Ampicillin: Escherichia coli
Aztreonam: Citrobacter freundii,
Enterobacter cloacae, Escherichia coli,
Klebsiella aerogenes, Klebsiella
oxytoca, Klebsiella pneumoniae,
Proteus mirabilis, Proteus vulgaris,
Serratia marcescens and Pseudomonas
aeruginosa
Cefazolin: Klebsiella pneumoniae
Cefepime: Enterobacter cloacae,
Escherichia coli, Klebsiella oxytoca,
Klebsiella pneumoniae, Proteus
mirabilis, Proteus vulgaris, Serratia
marcescens and Pseudomonas
aeruginosa
Ceftriaxone: Citrobacter freundii,
Enterobacter cloacae, Escherichia coli,
Klebsiella aerogenes, Klebsiella
oxytoca, Klebsiella pneumoniae,
Proteus mirabilis, Proteus vulgaris,
Serratia marcescens
Ertapenem: Citrobacter freundii,
Enterobacter cloacae, Escherichia coli,
Klebsiella aerogenes, Klebsiella
oxytoca, Klebsiella pneumoniae,
Proteus mirabilis, Proteus vulgaris,
Serratia marcescens
Gentamicin: Citrobacter freundii,
Enterobacter cloacae, Escherichia coli,
Klebsiella aerogenes, Klebsiella
oxytoca, Klebsiella pneumoniae,
Proteus mirabilis, Proteus vulgaris,
Serratia marcescens and Pseudomonas
aeruginosa
Levofloxacin: Citrobacter freundii,
Enterobacter cloacae, Escherichia coli,
Klebsiella aerogenes, Klebsiella
oxytoca, Klebsiella pneumoniae,
Proteus mirabilis, Proteus vulgaris,
Serratia marcescens, and Pseudomonas
aeruginosa
Meropenem: Acinetobacter spp.,
Citrobacter freundii, Enterobacter |
| Device & Predicate
Devices: | K223494
Device | K231536
Predicate |
| | Ciprofloxacin: Citrobacter freundii
complex, Citrobacter koseri,
Enterobacter cloacae complex,
Escherichia coli, Klebsiella
aerogenes, Klebsiella oxytoca,
Klebsiella pneumoniae, Morganella
morganii, Proteus mirabilis, Proteus
vulgaris, Serratia marcescens,
Pseudomonas aeruginosa | oxytoca, Klebsiella pneumoniae,
Proteus mirabilis, Proteus vulgaris,
Serratia marcescens, and Pseudomonas
aeruginosa |
| | Piperacillin-Tazobactam:
Acinetobacter baumannii complex,
Citrobacter koseri, Escherichia coli,
Klebsiella pneumoniae, Morganella
morganii, Proteus mirabilis, Proteus
vulgaris, Serratia marcescens,
Pseudomonas aeruginosa | |
| | Ertapenem: Citrobacter freundii
complex, Citrobacter koseri,
Enterobacter cloacae complex,
Escherichia coli, Klebsiella
aerogenes, Klebsiella oxytoca,
Klebsiella pneumoniae, Morganella
morganii, Proteus mirabilis, Proteus
vulgaris, Serratia marcescens | |
| | Gentamicin: Citrobacter freundii
complex, Citrobacter koseri,
Enterobacter cloacae complex,
Escherichia coli, Klebsiella
aerogenes, Klebsiella oxytoca,
Klebsiella pneumoniae, Morganella
morganii, Proteus mirabilis, Proteus
vulgaris, Serratia marcescens,
Pseudomonas aeruginosa | |
| | Imipenem: Acinetobacter baumannii
complex, Escherichia coli, Klebsiella
pneumoniae | |
| | Meropenem: Acinetobacter
baumannii complex, Citrobacter
freundii complex, Citrobacter koseri,
Enterobacter cloacae complex,
Escherichia coli, Klebsiella oxytoca,
Klebsiella pneumoniae, Morganella
morganii, Proteus mirabilis, Proteus
vulgaris, Serratia marcescens,
Pseudomonas aeruginosa | |
| | Minocycline: Acinetobacter
baumannii complex, Escherichia coli,
Klebsiella pneumoniae | |
| | Piperacillin-Tazobactam:
Acinetobacter baumannii complex,
Citrobacter koseri, Escherichia coli,
Klebsiella pneumoniae, Morganella
morganii, Proteus mirabilis, Proteus
vulgaris, Serratia marcescens,
Pseudomonas aeruginosa | |
| | | Piperacillin/tazobactam:
Acinetobacter spp., Escherichia coli,
Klebsiella pneumoniae, Proteus
mirabilis, Proteus vulgaris, Serratia
marcescens, and Pseudomonas
aeruginosa |
| | | Tobramycin: Citrobacter freundii,
Enterobacter cloacae, Escherichia coli,
Klebsiella aerogenes, Klebsiella
oxytoca, Klebsiella pneumoniae,
Proteus mirabilis, Proteus vulgaris,
Serratia marcescens, and Pseudomonas
aeruginosa |
| Device & Predicate
Devices: | K223494
Device | K231536
Predicate |
| | Tobramycin: Escherichia coli,
Klebsiella pneumoniae, Pseudomonas
aeruginosa | |
| Technology | Uses lysis, centrifugation and
sequential optical density
measurements to generate a
McFarland-equivalent suspension. | Measure pathogen concentration via
potentiometric sensing of changes in
oxidation-reduction potential (ORP)
during pathogen metabolism. Uses
species-specific and blood culture bottle
specific algorithms to determine when a
0.5 McFarland equivalent concentration
is reached. |
| Output/Results
Reported | Liquid suspension of bacteria
(McFarland equivalent) suitable for
susceptibility testing. | Same |
| AST | Selux AST System | Kirby-Bauer disc diffusion |
9
10
11
Despite the differences between the PBC Separator with Selux AST System and the predicate device, the overall risk and safety of system use is not affected.
Reproducibility
PBC Separator with Selux AST System Intra- and inter-site reproducibility was evaluated by testing a minimum of 5 samples for each of 9 representative antimicrobials at each of three sites (2 external, 1 internal). Each sample comprised an isolate that was seeded at approximately 10-10,000 CFU into a blood culture bottle with approximately 10 mL of fresh human blood from a healthy donor and then loaded into an FDA-cleared continuous monitoring blood culture system (BD BACTEC, bioMerieux BacT/ALERT 3D, or bioMerieux BacT/ALERT VIRTUO) until positive growth was detected. The positive blood culture bottle was then removed and processed using the PBC Separator and Selux AST System. Each sample was tested in triplicate using three different inoculums prepared by the PBC Separator on each of three days it was tested at each site. There is thus a minimum of 3 × 3 = 9 results per sample and 9 × 5 = 45 results per antimicrobial at a single site. The intra-site reproducibility is given in the following table. In each case, the bestand worst-case intra-site reproducibility was ≥ 95%.
| Intra-Site Reproducibility | |||
|---|---|---|---|
| Antimicrobial | N | Best-Case | Worst-Case |
| Ampicillin | 45 | 100% | 100% |
| Ampicillin-sulbactam | 54 | 100% | 100% |
| Amoxicillin-clavulanate | 45 | 100% | 100% |
| Cefazolin | 45 | 100% | 100% |
| Ceftazidime-avibactam | 45 | 100% | 100% |
| Ciprofloxacin | 54 | 100% | 100% |
12
| Intra-Site Reproducibility | |||
|---|---|---|---|
| Antimicrobial | N | Best-Case | Worst-Case |
| Gentamicin | 54 | 100% | 100% |
| Meropenem | 63 | 98.4% | 98.4% |
| Minocycline | 54 | 98.1% | 98.1% |
For inter-site reproducibility, there are a minimum of 3 × 3 × 3 = 27 results per sample and 27 × 5 = 135 results per antimicrobial. The inter-site reproducibility is given in the following table. In each case, the best- and worst-case intra-site reproducibility was > 95%.
| Inter-Site Reproducibility | |||
|---|---|---|---|
| Antimicrobial | N | Best-Case | Worst-Case |
| Ampicillin | 135 | 99.30% | 99.30% |
| Ampicillin-sulbactam | 162 | 100% | 100% |
| Amoxicillin-clavulanate | 135 | 100% | 100% |
| Cefazolin | 135 | 100% | 100% |
| Ceftazidime-avibactam | 135 | 100% | 100% |
| Ciprofloxacin | 162 | 100% | 100% |
| Gentamicin | 162 | 98.5% | 98.5% |
| Meropenem | 189 | 95.8% | 95.8% |
| Minocycline | 162 | 96.3% | 96.3% |
Other Analytical Studies:
Post-Positivity Sample Stability Study
The amount of time between the registration of positive growth for a sample and the initiation of processing with the PBC Separator was evaluated. Selux AST System MIC results from samples processed with the PBC Separator 16 hours after registering positive growth in a continuous monitoring blood culture system were compared with t = 0 hr control MIC results from samples processed on the PBC Separator immediately after registering positive growth. At least two replicates of one species from each indicated antimicrobial/organism reporting group was tested per drug per timepoint. Every antimicrobial agent at the 16-hour timepoint had essential agreement (EA) > 95%compared with the 0-hour timepoint. The total EA for all results at the 16-hour timepoint compared with the 0-hour timepoint was 99.6% (264/265 results in EA). Positive blood bottles should be processed promptly after ringing positive on a continuous blood culture monitoring system. In the case of unavoidable delays or if the need for sample re-testing arises, bottles must be processed within 16 hours post ring.
13
Blood Culture Bottle Compatibility Study
Eleven types of blood culture bottles listed below were evaluated with the PBC Separator with Selux AST System.
| Bottle Type | Blood Culture System Compatibility |
|---|---|
| BACTEC Plus Aerobic | BD BACTEC |
| BACTEC Plus Anaerobic | BD BACTEC |
| BACTEC Standard Aerobic | BD BACTEC |
| BACTEC Standard Anaerobic | BD BACTEC |
| BACTEC Lytic Anaerobic | BD BACTEC |
| BACTEC Peds Plus | BD BACTEC |
| BacT/ALERT FA Plus | BacT/ALERT 3D, VIRTUO |
| BacT/ALERT FN Plus | BacT/ALERT 3D, VIRTUO |
| BacT/ALERT SA | BacT/ALERT 3D, VIRTUO |
| BacT/ALERT SN | BacT/ALERT 3D, VIRTUO |
| BacT/ALERT PF Plus | BacT/ALERT 3D, VIRTUO |
Bacterial samples were seeded at clinically relevant concentrations into the blood culture bottles with the manufacturer recommended volume of healthy donor human blood. Seeded bottles were loaded into either a BD BACTEC or bioMérieux BacT/ALERT continuous monitoring blood culture system and incubated until positivity. Positive blood culture samples were then processed with the PBC Separator with Selux AST System. At least two replicates of one species from each indicated drug/organism reporting group was tested per bottle type and evaluated with all claimed antimicrobials. Aerobic bottles were seeded with A. baumannii (complex), E. coli, K. pneumoniae, and P. aeruginosa, and anaerobic bottles were seeded with E. coli, K. pneumoniae, P. mirabilis, and M. morganii.
Selux AST System MIC results from all tested bottle types showed >89.9% essential agreement (EA) to the reference method. Across all aerobic bottle types there was 99.3% EA (1629/1640 results in EA) and each aerobic bottle type had EA ≥ 98.5%. Across all anaerobic bottle types there was 99.5% EA (974/979 results in EA) and each anaerobic bottle type had EA ≥ 98.5%.
PBC Separator with Selux AST System performance with bioMérieux aerobic bottles is provided in the table below.
| Antimicrobial | Indicated
Organism(s) | bioMérieux
BacT/ALERT SA | | bioMérieux
BacT/ALERT FA
Plus | | bioMérieux
BacT/ALERT
PF Plus | | |
|-----------------------------|--------------------------------|-----------------------------|-----------------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------------------------|--|
| | | # EA /
Total | % EA | # EA /
Total | % EA | # EA /
Total | % EA | |
| Amikacin | A. baumannii
complex | 9/9 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | P. aeruginosa | 6/6 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Combined | 43/43 | 100.0% | 15/15 | 100.0% | 14/14 | 100.0% | |
| Antimicrobial | Indicated
Organism(s) | | bioMérieux
BacT/ALERT SA | | bioMérieux
BacT/ALERT FA
Plus | | bioMérieux
BacT/ALERT
PF Plus | |
| | | # EA /
Total | % EA | # EA /
Total | % EA | # EA /
Total | % EA | |
| Amoxicillin-
Clavulanate | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| Ampicillin | Enterobacterales | 22/22 | 100.0% | 7/7 | 100.0% | 6/6 | 100.0% | |
| Ampicillin-
Sulbactam | A. baumannii
complex | 9/9 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | Combined | 37/37 | 100.0% | 12/12 | 100.0% | 11/11 | 100.0% | |
| Cefazolin | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| Cefepime | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | P. aeruginosa | 6/6 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Combined | 34/34 | 100.0% | 12/12 | 100.0% | 11/11 | 100.0% | |
| Ceftazidime | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | P. aeruginosa | 3/3 | 100.0% | 2/2 | 100.0% | 3/3 | 100.0% | |
| | Combined | 31/31 | 100.0% | 11/11 | 100.0% | 11/11 | 100.0% | |
| Ceftazidime-
Avibactam | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | P. aeruginosa | 6/6 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Combined | 34/34 | 100.0% | 12/12 | 100.0% | 11/11 | 100.0% | |
| Ceftriaxone | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| Ciprofloxacin | Enterobacterales | 25/28 | 89.3%¹ | 9/9 | 100.0% | 8/8 | 100.0% | |
| | P. aeruginosa | 6/6 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Combined | 31/34 | 91.2% | 12/12 | 100.0% | 11/11 | 100.0% | |
| Ertapenem | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| Gentamicin | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | P. aeruginosa | 6/6 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Combined | 34/34 | 100.0% | 12/12 | 100.0% | 11/11 | 100.0% | |
| Imipenem | A. baumannii
complex | 9/9 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | Combined | 37/37 | 100.0% | 12/12 | 100.0% | 11/11 | 100.0% | |
| Meropenem | A. baumannii
complex | 9/9 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | P. aeruginosa | 6/6 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| Antimicrobial | Indicated
Organism(s) | bioMérieux
BacT/ALERT SA | | bioMérieux
BacT/ALERT FA Plus | | bioMérieux
BacT/ALERT PF Plus | | |
| | | # EA /
Total | % EA | # EA /
Total | % EA | # EA /
Total | % EA | |
| | Combined | 43/43 | 100.0% | 15/15 | 100.0% | 14/14 | 100.0% | |
| Minocycline | A. baumannii
complex | 9/9 | 100.0% | 2/3 | 66.7% | 2/3 | 66.7% | |
| | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | Combined | 37/37 | 100.0% | 11/12 | 91.7% | 10/11 | 90.9% | |
| Piperacillin-
Tazobactam | A. baumannii
complex | 9/9 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Enterobacterales | 26/28 | 92.9% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | P. aeruginosa | 6/6 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Combined | 41/43 | 95.3% | 15/15 | 100.0% | 14/14 | 100.0% | |
| Tobramycin | Enterobacterales | 28/28 | 100.0% | 9/9 | 100.0% | 8/8 | 100.0% | |
| | P. aeruginosa | 6/6 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% | |
| | Combined | 34/34 | 100.0% | 12/12 | 100.0% | 11/11 | 100.0% | |
14
15
1 Ciprofloxacin tested with Enterobacterales derived from bioMérieux BacT/ALERT SA bottles demonstrated an EA 89.9% EA for every interferent tested when compared with PBC Separator with Selux AST System results for the same organism run in a control condition (no interferent).
| | | Red Blood Cells
(20 g/dL) | | White Blood Cells
(12,000 cells/µL) | | Platelets
(450,000/μL) | | Gamma Globulins
(50 g/L) | |
|-------------------------------|-----------------------------|------------------------------|--------|----------------------------------------|----------------------------------------|---------------------------|---------------------------|-----------------------------|--------|
| Antimicrobial | Indicated Organism(s) | # EA /
Total | % EA | # EA /
Total | % EA | # EA /
Total | % EA | # EA /
Total | % EA |
| Amikacin | A. baumannii complex | 2/2 | 100.0% | 4/4 | 100.0% | 3/3 | 100.0% | 3/3 | 100.0% |
| | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| | P. aeruginosa | 2/2 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% | 4/4 | 100.0% |
| | Combined | 15/15 | 100.0% | 14/14 | 100.0% | 12/12 | 100.0% | 17/17 | 100.0% |
| | | Red Blood Cells
(20 g/dL) | | White Blood Cells
(12,000 cells/μL) | | Platelets
(450,000/μL) | | Gamma Globulins
(50 g/L) | |
| Antimicrobial | Indicated Organism(s) | # EA / Total | % EA | # EA / Total | % EA | # EA / Total | % EA | # EA / Total | % EA |
| Amoxicillin-Clavulanate | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| Ampicillin | Enterobacterales | 9/9 | 100.0% | 4/4 | 100.0% | 4/4 | 100.0% | 8/8 | 100.0% |
| | A. baumannii complex | /2/ | 100.0% | 4/4 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% |
| Ampicillin-Sulbactam | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| | Combined | 13/13 | 100.0% | 9/9 | 100.0% | 10/10 | 100.0% | 14/14 | 100.0% |
| Cefazolin | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| Cefepime | P. aeruginosa | 2/2 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% | 4/4 | 100.0% |
| | Combined | 13/13 | 100.0% | 10/10 | 100.0% | 9/9 | 100.0% | 14/14 | 100.0% |
| | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| Ceftazidime | P. aeruginosa | 1/1 | 100.0% | 4/4 | 100.0% | 4/4 | 100.0% | 2/2 | 100.0% |
| | Combined | 12/12 | 100.0% | 9/9 | 100.0% | 9/9 | 100.0% | 12/12 | 100.0% |
| | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| Ceftazidime-Avibactam | P. aeruginosa | 2/2 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% | 4/4 | 100.0% |
| | Combined | 13/13 | 100.0% | 10/10 | 100.0% | 9/9 | 100.0% | 14/14 | 100.0% |
| Ceftriaxone | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| Ciprofloxacin | P. aeruginosa | 2/2 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% | 4/4 | 100.0% |
| | Combined | 13/13 | 100.0% | 10/10 | 100.0% | 9/9 | 100.0% | 14/14 | 100.0% |
| Ertapenem | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| Gentamicin | P. aeruginosa | 2/2 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% | 4/4 | 100.0% |
| | Combined | 13/13 | 100.0% | 10/10 | 100.0% | 9/9 | 100.0% | 14/14 | 100.0% |
| | A. baumannii complex | 2/2 | 100.0% | 4/4 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% |
| Imipenem | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| | Combined | 13/13 | 100.0% | 9/9 | 100.0% | 10/10 | 100.0% | 14/14 | 100.0% |
| | A. baumannii complex | 2/2 | 100.0% | 4/4 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% |
| Meropenem | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| | P. aeruginosa | 2/2 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% | 4/4 | 100.0% |
| | | Red Blood Cells
(20 g/dL) | | | White Blood Cells
(12,000 cells/μL) | | Platelets
(450,000/μL) | Gamma Globulins
(50 g/L) | |
| Antimicrobial | Indicated Organism(s) | # EA /
Total | % EA | # EA /
Total | % EA | # EA /
Total | % EA | # EA /
Total | % EA |
| | Combined | 15/15 | 100.0% | 14/14 | 100.0% | 14/14 | 100.0% | 18/18 | 100.0% |
| | A. baumannii complex | 2/2 | 100.0% | 4/4 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% |
| Minocycline | Enterobacterales | 11/11 | 100.0% | 5/5 | 100.0% | 5/5 | 100.0% | 10/10 | 100.0% |
| | Combined | 13/13 | 100.0% | 9/9 | 100.0% | 10/10 | 100.0% | 14/14 | 100.0% |
| | A. baumannii complex | 2/2 | 100.0% | 4/4 | 100.0% | 3/6 | 60.0% | 4/4 | 100.0% |
| Piperacillin-
Tazobactam 1 | Enterobacterales | 2/11 | 18.2% | 1/5 | 20.0% | 1/5 | 20.0% | 2/10 | 20.0% |
| | P. aeruginosa | 2/2 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% | 4/4 | 100.0% |
| | Combined | 6/15 | 40.0% | 10/14 | 71.4% | 8/14 | 57.1% | 10/18 | 55.6% |
| Tobramycin | Enterobacterales | 10/11 | 90.9% | 4/5 | 80.0% | 5/5 | 100.0% | 9/10 | 90.0% |
| | P. aeruginosa | 2/2 | 100.0% | 5/5 | 100.0% | 4/4 | 100.0% | 4/4 | 100.0% |
| | Combined | 12/13 | 92.3% | 9/10 | 90.0% | 9/9 | 100.0% | 13/14 | 92.9% |
19
20
1 An essential agreement A. baumannii complex | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| Amikacin | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 10/11 | 90.9% |
| | P. aeruginosa | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Combined | 13/13 | 100.0% | 14/14 | 100.0% | 14/14 | 100.0% | 14/15 | 93.3% |
| Amoxicillin-
Clavulanate | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 10/11 | 90.9% |
| Ampicillin | Enterobacterales | 7/7 | 100.0% | 8/8 | 100.0% | 8/8 | 100.0% | 9/9 | 100.0% |
| Ampicillin-
Sulbactam | A. baumannii complex | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| | Combined | 11/11 | 100.0% | 12/12 | 100.0% | 12/12 | 100.0% | 13/13 | 100.0% |
| Cefazolin | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| | Enterobacterales | 7/9 | 77.8% | 9/10 | 90.0% | 8/10 | 80.0% | 11/11 | 100.0% |
| Cefepime | P. aeruginosa | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Combined | 9/11 | 81.8% | 11/12 | 91.7% | 10/12 | 83.3% | 13/13 | 100.0% |
| | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| Ceftazidime | P. aeruginosa | 0/0 | N/A 1 | 0/0 | N/A 1 | 1/1 | 100.0% | 1/1 | 100.0% |
| | Combined | 9/9 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% | 12/12 | 100.0% |
| | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 10/11 | 90.9% |
| Ceftazidime-
Avibactam | P. aeruginosa | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Combined | 11/11 | 100.0% | 12/12 | 100.0% | 12/12 | 100.0% | 12/13 | 92.3% |
| Ceftriaxone | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| | | | Cefpodoxime
(2.3 µg/mL) | Ciprofloxacin
(3.6 µg/mL) | | Gentamicin
(24 µg/mL) | | Penicillin
(6.0 µg/mL) | |
| Antimicrobial | Indicated Organism(s) | # EA /
Total | % EA | # EA /
Total | % EA | # EA /
Total | % EA | # EA /
Total | % EA |
| Ciprofloxacin | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| | P. aeruginosa | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Combined | 11/11 | 100.0% | 12/12 | 100.0% | 12/12 | 100.0% | 13/13 | 100.0% |
| Ertapenem | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| Gentamicin | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| | P. aeruginosa | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Combined | 11/11 | 100.0% | 12/12 | 100.0% | 12/12 | 100.0% | 13/13 | 100.0% |
| Imipenem | A. baumannii complex | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Enterobacterales | 5/9 | 55.6% | 9/10 | 90.0% | 7/10 | 70.0% | 11/11 | 100.0% |
| | Combined | 7/11 | 63.6% | 11/12 | 91.7% | 9/12 | 75.0% | 13/13 | 100.0% |
| Meropenem | A. baumannii complex | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Enterobacterales | 9/9 | 100.0% | 10/10 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| | P. aeruginosa | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Combined | 13/13 | 100.0% | 14/14 | 100.0% | 14/14 | 100.0% | 15/15 | 100.0% |
| Minocycline | A. baumannii complex | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Enterobacterales | 8/9 | 88.9% | 10/10 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| | Combined | 11/11 | 100.0% | 12/12 | 100.0% | 12/12 | 100.0% | 13/13 | 100.0% |
| Piperacillin-
Tazobactam | A. baumannii complex | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Enterobacterales | 9/9 | 100.0% | 10/10 | 90.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| | P. aeruginosa | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Combined | 13/13 | 100.0% | 14/14 | 91.7% | 14/14 | 100.0% | 15/15 | 100.0% |
| Tobramycin | Enterobacterales 1 | 7/9 | 77.8% | 10/10 | 100.0% | 10/10 | 100.0% | 11/11 | 100.0% |
| | P. aeruginosa | 2/2 | 100.0% | 2/2 | 97.0% | 2/2 | 100.0% | 2/2 | 100.0% |
| | Combined | 9/11 | 81.8% | 12/12 | 100.0% | 12/12 | 100.0% | 13/13 | 100.0% |
23
1 An essential agreement 89.9% EA to the broth microdilution reference method result. The EA for E. coli was 100% (60/60 results in EA) and the EA for K. pneumoniae was 98.2% (54/55 results in EA). Additionally, there was no contamination observed on purity plates.
Clinical Studies
The following table gives the antimicrobial-organism combinations tested and includes the reporting range and breakpoints of each combination.
| Antimicrobial | Abbreviation | Targeted
Organism | Selux
System
Reporting
Range | AST Breakpoints |
|-----------------------------|--------------|----------------------------------------------------------------|----------------------------------------------|----------------------------------------------------|
| Amikacin | AMK | A. baumannii
(complex)
Enterobacterales
P. aeruginosa | ≤0.12 to ≥256
≤2 to ≥256
≤0.12 to ≥256 | ≤16 / 32 / ≥64
≤16 / 32 / ≥64
≤16 / 32 / ≥64 |
| Amoxicillin-
Clavulanate | AMC | Enterobacterales | ≤2 to ≥128 | ≤8 / 16 / ≥32 |
| Ampicillin | AMP | Enterobacterales | ≤2 to ≥128 | ≤8 / 16 / ≥32 |
| Ampicillin-
Sulbactam | SAM | A. baumannii
(complex)
Enterobacterales | ≤2 to ≥128
≤0.5 to ≥128 | ≤8 / 16 / ≥32
≤8 / 16 / ≥32 |
| Cefazolin | CFZ | Enterobacterales | ≤0.12 to ≥128 | ≤2 / 4 / ≥8 |
| Cefepime | FEP | Enterobacterales
P. aeruginosa | ≤0.5 to ≥32
≤0.25 to ≥128 | ≤2 / 4-8 / ≥16
≤8 / ≥16 |
| Ceftazidime | CAZ | Enterobacterales
P. aeruginosa | ≤0.25 to ≥64
≤0.25 to ≥256 | ≤4 / 8 / ≥16
≤8 / ≥16 |
| Ceftazidime-
Avibactam | CZA | Enterobacterales
P. aeruginosa | ≤0.12 to ≥64
≤0.12 to ≥64 | ≤8 / ≥16
≤8 / ≥16 |
| Ceftriaxone | CRO | Enterobacterales | ≤0.25 to ≥32 | ≤1 / 2 / ≥4 |
| Ciprofloxacin | CIP | Enterobacterales
P. aeruginosa | ≤0.03 to ≥16
≤0.03 to ≥16 | ≤0.25 / 0.5 / ≥1
≤0.5 / 1 / ≥2 |
| Ertapenem | ETP | Enterobacterales | ≤0.03 to ≥16 | ≤0.5 / 1 / ≥2 |
| Gentamicin | GEN | Enterobacterales
P. aeruginosa | ≤1 to ≥64
≤0.5 to ≥64 | ≤4 / 8 / ≥16
≤4 / 8 / ≥16 |
| Imipenem | IMP | A. baumannii
(complex)
Enterobacterales | ≤0.5 to ≥64
≤0.25 to ≥16 | ≤2 / 4 / ≥8
≤1 / 2 / ≥4 |
| Meropenem | MEM | A. baumannii
(complex)
Enterobacterales
P. aeruginosa | ≤0.12 to ≥64
≤0.12 to ≥64
≤0.12 to ≥64 | ≤2 / 4 / ≥8
≤1 / 2 / ≥4
≤2 / 4 / ≥8 |
25
| Antimicrobial | Abbreviation | Targeted
Organism | Selux
System
Reporting
Range | AST Breakpoints |
|-----------------------------|--------------|------------------------------------------------------------------------------|---------------------------------------|--------------------|
| Minocycline | MIN | A. baumannii
(complex)
Enterobacterales | ≤0.25 to ≥64 | ≤4 / 8 / ≥16 |
| Piperacillin-
Tazobactam | TZP | A. baumannii
(complex)
Enterobacterales
P. aeruginosa | ≤4 to ≥512 | ≤16 / 32-64 / ≥128 |
| Tobramycin | TOB | Enterobacterales
P. aeruginosa | ≤0.12 to ≥128 | ≤4 / 8 / ≥16 |
Clinical performance testing with the PBC Separator with Selux AST System was performed at four test sites using fresh positive blood culture samples left over from routine clinical care and seeded samples. Seeded samples were prepared using banked frozen isolates seeded at 10-10,000 CFU into blood culture bottles together with approximately 10 mL of fresh human blood from a healthy donor and then loaded into an FDA-cleared continuous monitoring blood culture system until positive growth was detected. Positive blood bottles were tested with the PBC Separator and Selux AST System. Fresh positive blood culture samples were collected from two clinical sites serving all boroughs of New York City and seeded samples were chosen to represent geographic diversity across the continental U.S. A total of 469 clinical (162 fresh and 307 seeded) and 87 challenge isolates from 12 Enterobacterales species, Acinetobacter baumannii complex, and Pseudomonas aeruginosa were tested to evaluate the PBC Separator performance for 17 antimicrobials with the Selux AST System. Depending on the spectrum of activity, breakpoints, and the claimed organisms (species/group) for each antimicrobial on the panel, the number of datapoints for the various antimicrobial-organisms tested varied and ranged from 38 (e.g. A. baumannii/Amikacin) to 469 (e.g. Enterobacterales/Ciprofloxacin).
PBC Separator with Selux AST System performance was determined by comparing Selux AST System results from PBC Separator-prepared inoculums to triplicate broth microdilution results performed at an independent reference laboratory. The PBC Separator with the Selux AST System meets performance criteria for each indication and is given in the following table, where performance is summarized by drug and reporting group. Additionally, QC testing was performed every day testing was performed at each site and met the 95% performance criteria for all antimicrobials.
26
| Antimicrobial | Organism Group | Total
Tested | # in EA | % EA | Total Eval | # Eval in
EA | % EA of
Eval | # in CA | % CA | # R | # VMJ | # MAJ | # MIN |
|-------------------------|------------------------|-----------------|---------|------|------------|-----------------|-----------------|---------|------|-----|-------|-------|-------|
| Amikican | A. baumannii (complex) | 38 | 35 | 92.1 | 23 | 20 | 87 | 36 | 94.7 | 17 | 0 | 0 | 2 |
| | Enterobacterales | 216 | 208 | 96.3 | 24 | 16 | 66.7 | 213 | 98.6 | 8 | 0 | 0 | 3 |
| | P. aeruginosa | 44 | 42 | 95.5 | 43 | 41 | 95.3 | 40 | 90.9 | 6 | 0 | 0 | 4 |
| Amoxicillin-Clavulanate | Enterobacterales | 330 | 328 | 99.4 | 222 | 220 | 99.1 | 295 | 89.4 | 39 | 0 | 0 | 35 |
| Ampicillin | Enterobacterales | 149 | 148 | 99.3 | 4 | 3 | 75 | 148 | 99.3 | 96 | 0 | 0 | 1 |
| Ampicillin-Sulbactam | A. baumannii (complex) | 40 | 37 | 92.5 | 21 | 18 | 85.7 | 38 | 95 | 25 | 0 | 0 | 2 |
| | Enterobacterales | 352 | 347 | 98.6 | 303 | 298 | 98.3 | 306 | 86.9 | 135 | 0 | 0 | 46 |
| Cefazolin | Enterobacterales | 207 | 197 | 95.2 | 118 | 108 | 91.5 | 187 | 90.3 | 99 | 1 | 0 | 19 |
| Cefepime | Enterobacterales | 406 | 396 | 97.5 | 35 | 25 | 71.4 | 390 | 96.1 | 61 | 0 | 0 | 16 |
| | P. aeruginosa | 43 | 42 | 97.7 | 37 | 36 | 97.3 | 42 | 97.7 | 11 | 0 | 0 | 0 |
| Ceftazidime | Enterobacterales | 217 | 215 | 99.1 | 66 | 64 | 97 | 204 | 94 | 70 | 0 | 0 | 13 |
| | P. aeruginosa | 40 | 40 | 100 | 35 | 35 | 100 | 40 | 100 | 9 | 0 | 0 | 0 |
| Ceftazidime-Avibactam | Enterobacterales | 418 | 409 | 97.8 | 96 | 87 | 90.6 | 418 | 100 | 4 | 0 | 0 | 0 |
| | P. aeruginosa | 43 | 43 | 100 | 39 | 39 | 100 | 42 | 97.7 | 9 | 0 | 0 | 0 |
| Ceftriaxone | Enterobacterales | 373 | 370 | 99.2 | 18 | 15 | 83.3 | 370 | 99.2 | 111 | 0 | 1 | 2 |
| Ciprofloxacin | Enterobacterales | 469 | 461 | 98.3 | 82 | 74 | 90.2 | 457 | 97.4 | 117 | 0 | 1 | 11 |
| | P. aeruginosa | 43 | 43 | 100 | 32 | 32 | 100 | 42 | 97.7 | 13 | 0 | 0 | 1 |
| Ertapenem | Enterobacterales | 412 | 405 | 98.3 | 62 | 55 | 88.7 | 408 | 99 | 28 | 0 | 0 | 4 |
| Gentamicin | Enterobacterales | 466 | 459 | 98.5 | 33 | 26 | 78.8 | 459 | 98.5 | 64 | 0 | 1 | 6 |
| | P. aeruginosa | 43 | 42 | 97.7 | 31 | 30 | 96.8 | 42 | 97.7 | 8 | 0 | 0 | 1 |
| Imipenem | A. baumannii (complex) | 39 | 38 | 97.4 | 4 | 3 | 75 | 39 | 100 | 26 | 0 | 0 | 0 |
| | Enterobacterales | 213 | 205 | 96.2 | 14 | 6 | 42.9 | 209 | 98.1 | 20 | 0 | 1 | 3 |
| Meropenem | A. baumannii (complex) | 39 | 37 | 94.9 | 14 | 12 | 85.7 | 39 | 100 | 27 | 0 | 0 | 0 |
| | Enterobacterales | 394 | 388 | 98.5 | 19 | 13 | 68.4 | 390 | 99 | 19 | 0 | 0 | 4 |
| | P. aeruginosa | 43 | 40 | 93 | 28 | 25 | 89.3 | 39 | 90.7 | 13 | 0 | 0 | 4 |
| Minocycline | A. baumannii (complex) | 39 | 38 | 97.4 | 24 | 23 | 95.8 | 33 | 84.6 | 12 | 0 | 0 | 6 |
| | Enterobacterales | 218 | 209 | 95.9 | 193 | 184 | 95.3 | 195 | 89.4 | 32 | 0 | 2 | 21 |
| Piperacillin-Tazobactam | A. baumannii (complex) | 39 | 37 | 94.9 | 5 | 3 | 60 | 38 | 97.4 | 27 | 0 | 0 | 1 |
| | Enterobacterales | 320 | 313 | 97.8 | 36 | 29 | 80.6 | 312 | 97.5 | 37 | 0 | 1 | 7 |
| | P. aeruginosa | 43 | 42 | 97.7 | 40 | 39 | 97.5 | 42 | 97.7 | 9 | 0 | 0 | 1 |
| Tobramycin | Enterobacterales | 216 | 207 | 95.8 | 200 | 191 | 95.5 | 200 | 92.6 | 49 | 0 | 0 | 16 |
| | P. aeruginosa | 43 | 41 | 95.3 | 37 | 35 | 94.6 | 41 | 95.3 | 10 | 0 | 0 | 2 |
*Selux MIC values for the following antimicrobial/organism combinations tended to be one doubling dilution lower than the reference MIC value:
- Amikacin: A. baumannii (complex), E. coli, K. pneumoniae
- . Amoxicillin-clavulanate: K. pneumoniae
- Ampicillin: E. coli ●
- Cefazolin: E. coli, K. pneumoniae .
- Cefepime: P. aeruginosa, C. freundii complex, K. oxytoca ●
- Ceftazidime: P. aeruginosa ●
- Ciprofloxacin: E. coli .
- . Gentamicin: E. coli, K. pneumoniae
- Piperacillin-tazobactam: A. baumannii (complex), E. coli, S. marcescens, C. koseri
**Selux MIC values for the following antimicrobial/organism combinations tended to be one doubling dilution higher than the reference MIC value:
- Cefepime: E. cloacae (complex), E. coli, K. pneumoniae
- Ceftazidime: E. coli, K. pneumoniae ●
- Ceftazidime-avibactam: C. freundii (complex), C. koseri, E. coli, K. aerogenes, K. oxytoca, K. pneumoniae, M. ● morganii, P. mirabilis, P. vulgaris
- Ceftriaxone: C. freundii (complex), C. koseri, K. aerogenes, K. oxytoca, P. mirabilis, S. marcescens
- . Ciprofloxacin: C. freundii (complex), C. koseri, E. cloacae (complex), K. aerogenes, K. oxytoca, M. morganii, P. mirabilis, P. vulgaris, S. marcescens
- . Ertapenem: C. freundii (complex), C. koseri, E. cloacae (complex), K. oxytoca, P. mirabilis, P. vulgaris, S. marcescens
- . Gentamicin: P. mirabilis
- . Imipenem: K. pneumoniae
- Meropenem: C. freundii (complex), C. koseri, E. cloacae (complex), K. pneumonia, M. morganii, P. mirabilis, P. vulgaris, S. marcescens
- . Minocycline: A. baumannii (complex)
***Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combination: Ampicillin-Sulbactam: K. oxytoca, M. morganii
***Perform an alternative method of testing prior to results for the following antibiotic/organism combination: Cefazolin-E. coli when the Selux AST System MIC is 4 ug/mL due to the occurrence of minor errors, that were in essential agreement, resulting in a category agreement below 90%.
27
Conclusion
Based on our studies and testing, the PBC Separator with Selux AST System was determined to be substantially equivalent to the predicate device (K231536).