PBC Separator with Selux AST System

K223493 · Selux Diagnostics, Inc. · QZX · Feb 15, 2024 · Microbiology

Device Facts

• Record ID: K223493
• Device Name: PBC Separator with Selux AST System
• Applicant: Selux Diagnostics, Inc.
• Product Code: QZX · Microbiology
• Decision Date: Feb 15, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1650
• Device Class: Class 2

Intended Use

The PBC Separator with 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.

Device Story

The PBC Separator is an automated instrument that prepares bacterial inocula directly from positive blood culture bottles. It uses lysis, centrifugation, and sequential optical density measurements to generate a McFarland-equivalent suspension. The system is used in clinical laboratories by technicians. The prepared inoculum is transferred to the Selux AST System, which performs antimicrobial susceptibility testing (AST) by incubating samples and quantifying microbial growth in a 384-well panel. The system uses species-specific algorithms to determine minimum inhibitory concentrations (MICs). Results are used by clinicians to guide antibiotic therapy for patients with bloodstream infections. The device benefits patients by providing faster AST results (under 7 hours) compared to traditional methods, enabling timely targeted treatment.

Clinical Evidence

Clinical performance evaluated at four sites using 469 clinical (162 fresh, 307 seeded) and 87 challenge isolates. Performance compared to broth microdilution reference method. Results demonstrated high essential agreement (EA) and category agreement (CA) across 17 antimicrobials and various gram-negative organisms. Reproducibility studies (intra- and inter-site) showed >95% performance. Analytical studies included bottle compatibility, interfering substances, and carry-over/cross-contamination, all meeting performance criteria.

Technological Characteristics

Automated inoculum preparation system using lysis, centrifugation, and optical density sensing. Includes sample prep station (AST Workbench), Inoculator, Analyzer, and Workbench Computer. Uses 384-well Selux Gram Negative Panel. Connectivity via site workstation to LIS. Software-driven workflow with graphical user interface. Embedded firmware and workstation software.

Indications for Use

Indicated for automated inoculum preparation from positive blood culture samples (monomicrobial, gram-negative rods) for quantitative antimicrobial susceptibility testing (AST) using the Selux AST System. Requires prior organism identification for result interpretation. Performance demonstrated for specific antimicrobial agents and organisms including Acinetobacter baumannii complex, Citrobacter species, Enterobacter cloacae complex, Escherichia coli, Klebsiella species, Morganella morganii, Proteus species, Pseudomonas aeruginosa, and Serratia marcescens.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• eQUANT System (K231536)

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 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).

{2}------------------------------------------------

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 [phone] 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

{3}------------------------------------------------

#### 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)

#### 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 [e-mail]

"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."

{5}------------------------------------------------

### 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. [phone]

#### Contact:

Carrene Plummer Tel. [phone]

#### 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

{6}------------------------------------------------

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.

{7}------------------------------------------------

#### 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<br>Devices: | K223494<br>Device | K231536<br>Predicate |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | PBC Separator with Selux AST<br>System | eQUANT System |
| Device Characteristics | The PBC Separator with the Selux<br>AST System is an automated<br>inoculum preparation system that uses<br>lysis, centrifugation and sequential<br>optical density measurements to<br>generate a McFarland-equivalent<br>suspension from positive blood<br>culture samples that can be used for<br>quantitative in vitro antimicrobial<br>susceptibility testing by the Selux<br>AST System. Samples are processed<br>directly from blood culture samples<br>identified as positive by a continuous<br>monitoring blood culture system.<br>Samples should be confirmed as<br>monomicrobial, gram negative rods<br>by Gram stain. Organism<br>identification is required for AST<br>result interpretation and reporting, per<br>the Selux AST System instructions for<br>use. | The eQUANT™ System is an<br>automated inoculum preparation system<br>that uses potentiometric sensing of<br>oxidation-reduction potential changes<br>due to pathogen metabolism to generate<br>a 0.5 McFarland equivalent suspension<br>(the eMcFarland or eMcF) from positive<br>blood culture samples that can be used<br>for direct, qualitative in vitro<br>susceptibility testing by the agar disk<br>diffusion test method (Kirby-Bauer).<br>Samples are processed directly from<br>blood culture samples identified as<br>positive by a continuous monitoring<br>blood culture system and confirmed as<br>Gram-negative rods by Gram stain.<br>Organism identification must be<br>confirmed by an FDA cleared device for<br>direct testing from positive blood<br>culture before processing samples on<br>the eQUANT™ System. |
| Indication for Use | | |
| Device & Predicate<br>Devices: | K223494<br>Device | K231536<br>Predicate |
| Source of<br>Microorganisms | bacteria from positive blood cultures | Same |
| Indicated<br>Antimicrobial/Organism<br>Combinations | Amikacin: Acinetobacter baumannii<br>complex, Escherichia coli, Klebsiella<br>pneumoniae, Pseudomonas<br>aeruginosa<br>Amoxicillin-Clavulanate:<br>Escherichia coli, Klebsiella species<br>(including K. oxytoca, K.<br>pneumoniae), Proteus mirabilis,<br>Proteus vulgaris<br>Ampicillin: Escherichia coli, Proteus<br>mirabilis<br>Ampicillin-Sulbactam:<br>Acinetobacter baumannii complex,<br>Citrobacter koseri, Escherichia coli,<br>Klebsiella pneumoniae, Proteus<br>mirabilis<br>Cefazolin: Escherichia coli,<br>Klebsiella pneumoniae<br>Cefepime: Citrobacter freundii<br>complex, Citrobacter koseri,<br>Enterobacter cloacae complex,<br>Escherichia coli, Klebsiella<br>aerogenes, Klebsiella oxytoca,<br>Klebsiella pneumoniae, Morganella<br>morganii, Proteus mirabilis, Proteus<br>vulgaris, Serratia marcescens,<br>Pseudomonas aeruginosa<br>Ceftazidime: Escherichia coli,<br>Klebsiella pneumoniae, Pseudomonas<br>aeruginosa<br>Ceftazidime-Avibactam: Citrobacter<br>freundii complex, Citrobacter koseri,<br>Enterobacter cloacae complex,<br>Escherichia coli, Klebsiella<br>aerogenes, Klebsiella oxytoca,<br>Klebsiella pneumoniae, Morganella<br>morganii, Proteus mirabilis, Proteus<br>vulgaris, Serratia marcescens,<br>Pseudomonas aeruginosa<br>Ceftriaxone: Citrobacter freundii<br>complex, Citrobacter koseri,<br>Enterobacter cloacae complex,<br>Escherichia coli, Klebsiella<br>aerogenes, Klebsiella oxytoca,<br>Klebsiella pneumoniae, Proteus<br>mirabilis | Amoxicillin/clavulanate: Escherichia<br>coli, Klebsiella oxytoca, Klebsiella<br>pneumoniae, Proteus mirabilis<br>Ampicillin: Escherichia coli<br>Aztreonam: Citrobacter freundii,<br>Enterobacter cloacae, Escherichia coli,<br>Klebsiella aerogenes, Klebsiella<br>oxytoca, Klebsiella pneumoniae,<br>Proteus mirabilis, Proteus vulgaris,<br>Serratia marcescens and Pseudomonas<br>aeruginosa<br>Cefazolin: Klebsiella pneumoniae<br>Cefepime: Enterobacter cloacae,<br>Escherichia coli, Klebsiella oxytoca,<br>Klebsiella pneumoniae, Proteus<br>mirabilis, Proteus vulgaris, Serratia<br>marcescens and Pseudomonas<br>aeruginosa<br>Ceftriaxone: Citrobacter freundii,<br>Enterobacter cloacae, Escherichia coli,<br>Klebsiella aerogenes, Klebsiella<br>oxytoca, Klebsiella pneumoniae,<br>Proteus mirabilis, Proteus vulgaris,<br>Serratia marcescens<br>Ertapenem: Citrobacter freundii,<br>Enterobacter cloacae, Escherichia coli,<br>Klebsiella aerogenes, Klebsiella<br>oxytoca, Klebsiella pneumoniae,<br>Proteus mirabilis, Proteus vulgaris,<br>Serratia marcescens<br>Gentamicin: Citrobacter freundii,<br>Enterobacter cloacae, Escherichia coli,<br>Klebsiella aerogenes, Klebsiella<br>oxytoca, Klebsiella pneumoniae,<br>Proteus mirabilis, Proteus vulgaris,<br>Serratia marcescens and Pseudomonas<br>aeruginosa<br>Levofloxacin: Citrobacter freundii,<br>Enterobacter cloacae, Escherichia coli,<br>Klebsiella aerogenes, Klebsiella<br>oxytoca, Klebsiella pneumoniae,<br>Proteus mirabilis, Proteus vulgaris,<br>Serratia marcescens, and Pseudomonas<br>aeruginosa<br>Meropenem: Acinetobacter spp.,<br>Citrobacter freundii, Enterobacter |
| Device & Predicate<br>Devices: | K223494<br>Device | K231536<br>Predicate |
| | <b>Ciprofloxacin:</b> Citrobacter freundii<br>complex, Citrobacter koseri,<br>Enterobacter cloacae complex,<br>Escherichia coli, Klebsiella<br>aerogenes, Klebsiella oxytoca,<br>Klebsiella pneumoniae, Morganella<br>morganii, Proteus mirabilis, Proteus<br>vulgaris, Serratia marcescens,<br>Pseudomonas aeruginosa | oxytoca, Klebsiella pneumoniae,<br>Proteus mirabilis, Proteus vulgaris,<br>Serratia marcescens, and Pseudomonas<br>aeruginosa |
| | <b>Piperacillin-Tazobactam:</b><br>Acinetobacter baumannii complex,<br>Citrobacter koseri, Escherichia coli,<br>Klebsiella pneumoniae, Morganella<br>morganii, Proteus mirabilis, Proteus<br>vulgaris, Serratia marcescens,<br>Pseudomonas aeruginosa | |
| | <b>Ertapenem:</b> Citrobacter freundii<br>complex, Citrobacter koseri,<br>Enterobacter cloacae complex,<br>Escherichia coli, Klebsiella<br>aerogenes, Klebsiella oxytoca,<br>Klebsiella pneumoniae, Morganella<br>morganii, Proteus mirabilis, Proteus<br>vulgaris, Serratia marcescens | |
| | <b>Gentamicin:</b> Citrobacter freundii<br>complex, Citrobacter koseri,<br>Enterobacter cloacae complex,<br>Escherichia coli, Klebsiella<br>aerogenes, Klebsiella oxytoca,<br>Klebsiella pneumoniae, Morganella<br>morganii, Proteus mirabilis, Proteus<br>vulgaris, Serratia marcescens,<br>Pseudomonas aeruginosa | |
| | <b>Imipenem:</b> Acinetobacter baumannii<br>complex, Escherichia coli, Klebsiella<br>pneumoniae | |
| | <b>Meropenem:</b> Acinetobacter<br>baumannii complex, Citrobacter<br>freundii complex, Citrobacter koseri,<br>Enterobacter cloacae complex,<br>Escherichia coli, Klebsiella oxytoca,<br>Klebsiella pneumoniae, Morganella<br>morganii, Proteus mirabilis, Proteus<br>vulgaris, Serratia marcescens,<br>Pseudomonas aeruginosa | |
| | <b>Minocycline:</b> Acinetobacter<br>baumannii complex, Escherichia coli,<br>Klebsiella pneumoniae | |
| | <b>Piperacillin-Tazobactam:</b><br>Acinetobacter baumannii complex,<br>Citrobacter koseri, Escherichia coli,<br>Klebsiella pneumoniae, Morganella<br>morganii, Proteus mirabilis, Proteus<br>vulgaris, Serratia marcescens,<br>Pseudomonas aeruginosa | |
| | | <b>Piperacillin/tazobactam:</b><br>Acinetobacter spp., Escherichia coli,<br>Klebsiella pneumoniae, Proteus<br>mirabilis, Proteus vulgaris, Serratia<br>marcescens, and Pseudomonas<br>aeruginosa…