(590 days)
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No
The document mentions an "algorithm" for determining susceptibility, but there is no mention of AI, ML, deep learning, or any related terms or concepts. The description of performance studies focuses on traditional statistical metrics and comparisons to a reference method, not on training or validation of an AI/ML model.
No
The device is an in vitro diagnostic (IVD) system used for automated quantitative susceptibility testing of microorganisms to determine their susceptibility to antimicrobial agents. It does not directly provide therapy.
Yes
The device is intended for "automated quantitative susceptibility testing for most clinically significant aerobic microorganisms," and the "Indications for Use" specify its use "as an in vitro test to determine the susceptibility of isolated colonies of specific Staphylococcus species to specific antimicrobial agents." This directly relates to diagnosing antimicrobial resistance, which is a key aspect of diagnosis.
No
The device description explicitly states that the Selux AST System consists of hardware components including a Sample Prep Station, an Inoculator, an Analyzer, and a computer workstation, in addition to software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The Intended Use explicitly states that the system is for "automated quantitative susceptibility testing for most clinically significant aerobic microorganisms." This is a diagnostic test performed on biological samples (microorganisms).
- Indications for Use: The Indications for Use further clarifies that the Selux Gram-Positive Panel is intended for use "as an in vitro test to determine the susceptibility of isolated colonies of specific Staphylococcus species to species to specific antimicrobial agents." The phrase "in vitro test" is a key indicator of an IVD.
- Device Description: The description details a system that processes samples and reagents to determine the susceptibility of microorganisms to antimicrobial agents. This process is performed outside of the body (in vitro) on biological samples.
- Performance Studies: The performance studies describe testing performed on "clinical isolates" and "stock challenge isolates" to evaluate the system's performance in determining susceptibility. This is consistent with the evaluation of a diagnostic device.
- Predicate Device: The mention of a "Predicate Device" with a K number (K131331; BD Phoenix Automated Microbiology System) is a strong indicator that this device is being submitted for regulatory review as a medical device, specifically an IVD, as predicate devices are used for comparison in submissions like 510(k) applications for IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
The Selux Gram-Positive Panel is intended for use with the Selux AST System as an in vitro test to determine the susceptibility of isolated colonies of specific Staphylococcus species and Enterococcus species to specific antimicrobial agents when used as instructed.
The Selux Gram-Positive Panel is a quantitative test for the following antimicrobial agents with the specific organisms identified below:
- Ampicillin: Enterococcus faecium, Enterococcus faecalis O
- Clindamycin: Staphylococcus aureus, Staphylococcus epidermidis O
- Ceftaroline: Staphylococcus aureus o
- Daptomycin: Staphylococcus aureus, Enterococcus faecalis O
- Delafloxacin: Staphylococcus aureus, Staphylococcus haemolyticus, Enterococcus o faecalis
- Eravacycline: Staphylococcus aureus, Enterococcus faecalis O
- Erythromycin: Staphylococcus aureus O
- Linezolid: Staphylococcus aureus, Staphylococcus epidermidis, Staphvlococcus o haemolyticus, Enterococcus faecium, Enterococcus faecalis
- Levofloxacin: Enterococcus faecium, Enterococcus faecalis, methicillin-susceptible o Staphylococcus aureus
- Minocycline: Staphylococcus aureus O
- Oxacillin: Staphylococcus aureus, Staphylococcus lugdunensis O
- Penicillin: Enterococcus faecium. Enterococcus faecalis. Staphylococcus aureus o
- Trimethoprim: Staphylococcus aureus, Coagulase-Negative Staphylococci (CoNS) O (including S. capitis, S. haemolyticus, S. saprophyticus, S. simulans)
- Vancomycin: Staphylococcus aureus, Coagulase-Negative Staphylococci (CoNS) O (including S. capitis, S. cohnii. S. epidermidis, S. hamolyticus, S. intermedius group, S. lugdunensis, S. saprophyticus, S. schleiferi, S. simulans) Enterococcus faecium, Enterococcus faecalis
The Selux Gram-Positive Panel is a qualitative test for the following antimicrobial agents with the specific target organisms identified below:
- Cefoxitin Screen to predict mecA-mediated oxacillin resistance: Staphylococcus aureus, o Staphylococcus lugdunensis
Product codes (comma separated list FDA assigned to the subject device)
LON, LTT, LTW
Device Description
The Selux AST System for antimicrobial susceptibility testing (AST) consists of a Sample Prep Station, an Inoculator, an Analyzer, a computer workstation, and the reagents and consumables required to perform AST testing. The system is operated via software that guides users through the manual sample preparation process and operates the automated Inoculator and Analyzer. The software includes an algorithm that enables the system to determine the susceptibilities of an organism to the variety of antimicrobials under test.
The system is designed so that only Gram stain information is required to initiate testing (to select the proper antimicrobial panel, gram-negative or gram-positive). While complete system testing can be performed without species-level identification (ID), this information is required for the system to report susceptibility results. Species ID can be performed by any appropriate method and this information can be either manually input to the Selux system or automatically downloaded from the laboratory information system (LIS) at any time, once the sample ID is entered into the LIS.
The system utilizes 384-well panels to provide parallel results for a large number of antimicrobials. Its average time-to-result is under 6 hours, as demonstrated in various studies.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
Clinical performance testing on the Selux AST System was performed at three test sites. Contemporary and frozen clinical isolates from diverse geographic locations across the US were evaluated for performance as well as stock (frozen/banked) challenge isolates, which were selected for their rare resistance profiles. A total of 706 clinical (193 contemporary and 513 stock) and 159 challenge samples from 11 Staphylococci and 2 Enterococci species were tested to evaluate the Selux AST System performance for 14 antimicrobials and one screening test, the Cefoxitin Screen. 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 39 (e.g. S. lugdunensis/Oxacillin) to 311 (e.g. Staphylococcus/Clindamycin).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reproducibility:
Intra-site reproducibility: Evaluated at a single site from the inter-site reproducibility testing and clinical study. A minimum of 5 isolates for each antimicrobial were tested in triplicate from three separate inoculums on three separate days for a total of 45 results per antimicrobial. Best-case intra-site reproducibility was ≥95% and worst-case intra-site reproducibility was ≥89%.
Inter-site reproducibility: Evaluated by testing a minimum of 25 isolates for each of the 14 antimicrobials plus one screening test at each of three test sites that participated in the clinical study. Each isolate was tested once at each site for a total of three results per isolate (minimum 75 results per antimicrobial). Best-case inter-site reproducibility was ≥95% and worst-case inter-site reproducibility was ≥89%.
Clinical Studies:
Selux AST System performance was determined by comparing Selux AST System results with triplicate broth microdilution results performed at an independent reference laboratory. The Selux AST System meets performance criteria for each indication. Total samples tested were 706 clinical (193 contemporary and 513 stock) and 159 challenge samples from 11 Staphylococci and 2 Enterococci species. The number of datapoints for the various antimicrobial-organisms tested varied and ranged from 39 (e.g. S. lugdunensis/Oxacillin) to 311 (e.g. Staphylococcus/Clindamycin).
QC testing was performed every day testing was performed at each site and met the 95% performance criteria for all antimicrobials.
Key Results are provided in the table under "Clinical Studies" in the original document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics for clinical studies include:
% EA (Essential Agreement)
% CA (Category Agreement)
R (Resistant)
VMJ (Very Major Errors)
MAJ (Major Errors)
MIN (Minor Errors)
Specific values for these metrics are provided in the table under "Clinical Studies" in the original document for various antimicrobial-organism combinations.
For example:
Ampicillin / Enterococcus spp.: % EA = 98.3, % CA = 100, # VMJ = 0, # MAJ = 0, # MIN = 0.
Clindamycin / Staphylococcus spp.: % EA = 95.8, % CA = 97.1, # VMJ = 1, # MAJ = 3, # MIN = 5.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 18, 2023
Selux Diagnostics, Inc. % Patricia Shrader Regulatory Consultant PBO Consulting 2212 East Pratt Street Baltimore, Maryland 21231
Re: K211759
Trade/Device Name: Selux AST System; Model AST Gen 1.0 Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTT, LTW Dated: June 4, 2021 Received: June 7, 2021
Dear Patricia Shrader:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -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
Enclosure
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Indications for Use
510(k) Number (if known) K211759
Device Name Selux AST System
Indications for Use (Describe)
Intended Use:
The Selux AST System is intended to be used for the automated quantitative susceptibility testing for most clinically significant aerobic microorganisms. The Selux AST System does not provide organism identification.
Indications for Use:
The Selux Gram-Positive Panel is intended for use with the Selux AST System as an in vitro test to determine the susceptibility of isolated colonies of specific Staphylococcus species to species to specific antimicrobial agents when used as instructed.
The Selux Gram-Positive Panel is a quantitative test for the following antimicrobial agents with the specific organisms identified below:
- Ampicillin: Enterococcus faecium, Enterococcus faecalis
- Clindamycin: Staphylococcus aureus, Staphylococcus epidermidis
- Ceftaroline: Staphylococcus aureus ●
- Daptomycin: Staphylococcus aureus, Enterococcus faecalis
- Delafloxacin: Staphylococcus aureus, Staphylococcus haemolyticus, Enterococcus faecalis
- . Eravacycline: Staphylococcus aureus, Enterococcus faecalis
- Erythromycin: Staphylococcus aureus
- . Linezolid: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Enterococcus faecium, Enterococcus faecalis
- Levofloxacin: Enterococcus faccium, Enterococcus faecalis, methicillin-susceptible Staphylococcus aureus .
- Minocycline: Staphylococcus aureus ●
- Oxacillin: Staphylococcus aureus, Staphylococcus lugdunensis ●
- Penicillin: Enterococcus faecium, Enterococcus faecalis, Staphylococcus aureus ●
- Trimethoprim: Staphylococcus aureus, Coagulase-Negative Staphylococci (including S. capitus, S. . haemolyticus, S. saprophyticus, S. simulans)
- Vancomycin: Staphylococcus aureus, Coagulase-Negative Staphylococci (CoNS) (including S. capitus, S. cohnii, ● S. epidermidis, S. haemolyticus, S. internedius group, S. lugdunensis, S. saprophyticus, S. schleiferi, S. simulans) Enterococcus faecium, Enterococcus faecalis
The Selux Gram-Positive Panel is a qualitative test for the following antimicrobial agents with the specific target organisms identified below:
- Cefoxitin Screen to predict mecA-mediated oxacillin resistance: Staphylococcus aureus, Staphylococcus ● lugdunensis
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for the Selux AST System, Antimicrobial Susceptibility Test System
Date prepared: December 10, 2022
Submitter:
Selux Diagnostics, Inc. 56 Roland St Suite 106 Charlestown, MA 02129 Tel. 617-945-9383
Contact:
Eric Stern, Ph.D. Tel. 617-945-9383
Subject Device
| Trade Name: | Selux AST System |
|---|---|
| Common Name: | Antimicrobial Susceptibility Test System |
| Regulation Number: | 21 CFR 866.1645 |
| Regulation Name: | Fully automated short-term incubation cycle antimicrobial susceptibility system |
| Regulatory Class: | Class II |
| Product Code: | LON, LTT, LTW |
| Classification Panel: | 83 (Microbiology) |
Primary Predicate Device(s)
| Trade Name: | BD Phoenix Automated Microbiology System- Vancomycin 0.5-32 µg/mL |
|---|---|
| Manufacturer: | Becton, Dickinson and Company |
| 510(k) Reference: | K131331 |
| Common Name: | Antimicrobial Susceptibility Test System |
| Regulation Number: | 21 CFR 866.1645 |
| Regulation Name: | Fully automated short-term incubation cycle antimicrobial susceptibility system |
| Regulatory Class: | Class II |
| Product Code: | LON |
| Classification Panel: | 83 (Microbiology) |
Device Description
The Selux AST System for antimicrobial susceptibility testing (AST) consists of a Sample Prep Station, an Inoculator, an Analyzer, a computer workstation, and the reagents and consumables required to perform AST testing. The system is operated via software that guides users through the manual sample preparation process and operates the automated Inoculator and Analyzer. The software includes an algorithm that enables the system to determine the susceptibilities of an organism to the variety of antimicrobials under test.
5
The system is designed so that only Gram stain information is required to initiate testing (to select the proper antimicrobial panel, gram-negative or gram-positive). While complete system testing can be performed without species-level identification (ID), this information is required for the system to report susceptibility results. Species ID can be performed by any appropriate method and this information can be either manually input to the Selux system or automatically downloaded from the laboratory information system (LIS) at any time, once the sample ID is entered into the LIS.
The system utilizes 384-well panels to provide parallel results for a large number of antimicrobials. Its average time-to-result is under 6 hours, as demonstrated in various studies.
Principle of Operation
The Selux platform 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 MIC by comparing growth data in each well. The Selux AST test requires that the Gram type (Classification) of the organism be known prior to testing as the information is necessary to select the proper AST panel to use. The organism identification (ID) need not be known for Selux AST processing to be performed. However, the organism ID is necessary for a result to be obtained 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, matrixassisted laser desorption/isotherm mass spectrometry, and multiplex genetic assays.
To ensure accurate results, the Selux method initiates antimicrobial susceptibility assays only after sufficient microorganism replication has occurred. Following determination of sufficient growth, two complementary metabolic assays are performed that quantify microbial growth, namely an indicator assay to estimate the number of bacteria present and a surface binding assay. These data are input to an MIC-determining algorithm that provides results when organism IDs are available. The sufficient growth assay ensures that the metabolic reagents used for the high-sensitivity organism quantification assays are not added until after sufficient microbial growth has occurred. To get an accurate reading of microbial replication, the sufficient growth assay monitors growth in dedicated AST panel wells that contain organisms and cation-adjusted Mueller-Hinton Broth but no antimicrobials or probes. Sufficient growth assay wells are monitored by fluorescence to those wells which the standard viability assay pair resazurin/methylene blue have been added and/or bv optical absorbance.
Two probe-based assays, a viability assay and a surface area assay, commence across all wells in the panel after the sufficient growth threshold has been met. Both of these assays are performed in each AST panel well, providing two complementary datasets for each well.
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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The Selux Gram-Positive Panel is intended for use with the Selux AST System as an in vitro test to determine the susceptibility of isolated colonies of specific Staphylococcus species and Enterococcus species to specific antimicrobial agents when used as instructed.
The Selux Gram-Positive Panel is a quantitative test for the following antimicrobial agents with the specific organisms identified below:
- Ampicillin: Enterococcus faecium, Enterococcus faecalis O
- Clindamycin: Staphylococcus aureus, Staphylococcus epidermidis O
- Ceftaroline: Staphylococcus aureus o
- Daptomycin: Staphylococcus aureus, Enterococcus faecalis O
- Delafloxacin: Staphylococcus aureus, Staphylococcus haemolyticus, Enterococcus o faecalis
- Eravacycline: Staphylococcus aureus, Enterococcus faecalis O
- Erythromycin: Staphylococcus aureus O
- Linezolid: Staphylococcus aureus, Staphylococcus epidermidis, Staphvlococcus o haemolyticus, Enterococcus faecium, Enterococcus faecalis
- Levofloxacin: Enterococcus faecium, Enterococcus faecalis, methicillin-susceptible o Staphylococcus aureus
- Minocycline: Staphylococcus aureus O
- Oxacillin: Staphylococcus aureus, Staphylococcus lugdunensis O
- Penicillin: Enterococcus faecium. Enterococcus faecalis. Staphylococcus aureus o
- Trimethoprim: Staphylococcus aureus, Coagulase-Negative Staphylococci (CoNS) O (including S. capitis, S. haemolyticus, S. saprophyticus, S. simulans)
- Vancomycin: Staphylococcus aureus, Coagulase-Negative Staphylococci (CoNS) O (including S. capitis, S. cohnii. S. epidermidis, S. hamolyticus, S. intermedius group, S. lugdunensis, S. saprophyticus, S. schleiferi, S. simulans) Enterococcus faecium, Enterococcus faecalis
The Selux Gram-Positive Panel is a qualitative test for the following antimicrobial agents with the specific target organisms identified below:
- Cefoxitin Screen to predict mecA-mediated oxacillin resistance: Staphylococcus aureus, o Staphylococcus lugdunensis
Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the Selux AST System are substantially equivalent to the predicate, the BD Phoenix Automated Microbiology System- Vancomycin 0.5-32 ug/mL (K131331) in terms of intended use, application, user population, basic design, performance, and labeling.
| Specification | Selux AST System | K131331 |
|---|---|---|
| Device Trade Name | Selux AST System | BD Phoenix Automated |
| Microbiology System- | ||
| Vancomycin 0.5-32 µg/mL | ||
| Specification | Selux AST System | K131331 |
| Indication 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. |
The Selux Gram-Positive Panel is intended for use with the Selux AST System as an in vitro test to determine the susceptibility of isolated colonies of specific Staphylococcus species and Enterococcus species to specific antimicrobial agents when used as instructed. | The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) of gram positive bacteria from pure culture belonging to the genera Staphylococcus , Enterococcus , other gram positive cocci and gram positive bacilli. The BD Phoenix Automated Microbiology System is also intended for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus . |
| Sources of Microorganisms | Bacterial colonies isolated from culture | Same |
| Technology | Automated growth-based detection | Same |
| Methodology | Determinations of MIC using serial two-fold dilution format | Same |
| Read Method | Automated | Same |
| Inoculation Method | Automated | Same |
| Result Reported | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (S, I, R, NS) | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (S, I, R) |
| General Device Characteristic Differences | | |
| Antimicrobial Agent and
Reporting Range | Ampicillin - ≤0.25 to ≥128 µg/mL
Clindamycin - ≤0.03 to ≥16 µg/mL
Ceftaroline - ≤0.06 to ≥32 µg/mL
Daptomycin - ≤0.06 to ≥32 µg/mL
Delafloxacin - ≤0.008 to ≥8 µg/mL
Eravacycline - ≤0.002 to ≥0.5 µg/mL
Erythromycin - ≤0.06 to ≥32 µg/mL
Levofloxacin - ≤0.06 to ≥32 µg/mL
Linezolid - ≤0.25 to ≥32 µg/mL
Minocycline - ≤0.12 to ≥64 µg/mL
Oxacillin - ≤0.03 to ≥32 µg/mL
Penicillin - ≤0.03 to ≥64 µg/mL
Trimethoprim – ≤0.25 to ≥64 µg/mL
Vancomycin - ≤0.12 to ≥128 µg/mL | Vancomycin ≤0.5 to ≥64 µg/mL |
| IVD Functions | AST | ID and AST |
| Instrument | Selux AST System | BD Phoenix Automated Microbiology System |
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Despite the differences between the Selux AST System and the predicate, the overall risk and safety of system use is not affected.
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Reproducibility
Intra-site reproducibility was evaluated at a single site that participated in the inter-site reproducibility testing and the clinical study. A minimum of 5 isolates for each antimicrobial were tested in triplicate from three separate inoculums on three separate days for a total of 45 results per antimicrobial. Best-case intra-site reproducibility was ≥95% and worst-case intra-site reproducibility was ≥89% (see following table). Please note the best-case intra-site reproducibility for erythromycin is 93.6%, which is Staphylococcus aureus ,
Staphylococcus lugdunensis | 175 | 172 | 98.3 | 81 | 1 | 2 |
Conclusion
Based on our studies and testing, the Selux AST System was determined to be substantially equivalent to the predicate device (K131331).
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1 EA performance (