← Product Code [PAM](/submissions/MI/subpart-d%E2%80%94serological-reagents/PAM) · K243490

# LIAISON PLEX Gram-Positive Blood Culture Assay (K243490)

_Luminex Corporation · PAM · Jun 6, 2025 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PAM/K243490

## Device Facts

- **Applicant:** Luminex Corporation
- **Product Code:** [PAM](/submissions/MI/subpart-d%E2%80%94serological-reagents/PAM.md)
- **Decision Date:** Jun 6, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3365
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Intended Use

The LIAISON PLEX® Gram-Positive Blood Culture (BCP) Assay, performed using the automated, sample-to-result LIAISON PLEX® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-positive pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles. The LIAISON PLEX BCP Assay is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria as determined by Gram stain. The LIAISON PLEX® BCP Assay contains targets for the detection of genetic determinants associated with resistance to methicillin (mecA/mecC) and vancomycin (vanA and vanB) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In mixed growth, the LIAISON PLEX BCP Assay does not specifically attribute vanA/vanB-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA/mecC-mediated methicillin resistance to either Staphylococcus spp., S. aureus, S. epidermidis or S. lugdunensis. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of methicillin and vancomycin resistance exist. The LIAISON PLEX® BCP Assay is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections (BSI). The LIAISON PLEX® BCP Assay is not intended to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by the LIAISON PLEX BCP Assay, to detect mixed infections that may not be detected by the LIAISON PLEX BCP Assay, for association of antimicrobial resistance genes to a specific organism, or for epidemiological typing.

## Device Story

Automated, sample-to-answer, bench-top diagnostic system; processes positive blood culture bottles containing gram-positive bacteria. Workflow: user loads sample into disposable cartridge; system performs mechanical/chemical cell lysis and magnetic bead-based nucleic acid isolation; no PCR amplification. Extracted nucleic acids hybridize to target-specific capture DNA on a microarray; gold nanoparticle probes bind to targets; silver enhancement enables light-scatter measurement. Output: qualitative detection/identification of gram-positive pathogens and resistance markers. Used in clinical laboratories by trained personnel. Results aid clinicians in diagnosing bacterial bloodstream infections; sub-culturing remains necessary for AST and epidemiological typing.

## Clinical Evidence

Multi-site clinical study (4 US sites) evaluated 562 prospective specimens, supplemented by 162 pre-selected and 225 contrived specimens. Comparator: culture followed by VITEK 2 or PCR/BDS. Overall testing success rate 99.9%. Sensitivity/PPA and specificity/NPA were high across targets (e.g., S. aureus sensitivity 99.4%, specificity 99.8%; Enterococcus faecalis sensitivity 100%, specificity 100%).

## Technological Characteristics

Automated bench-top system; disposable test cartridge. Nucleic acid extraction via mechanical/chemical lysis and magnetic beads. Detection via microarray-based hybridization with gold nanoparticle probes and silver enhancement. Non-amplified (no PCR). Connectivity: barcode scanning for sample/cartridge ID. Standards: ISO 14971, IEC 62366-1, ISO 62304, IEC 61010-1, IEC 60601-1-2.

## Regulatory Identification

A multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood cultures that test positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences for microorganism identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when used in conjunction with other clinical and laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.

## Special Controls

In combination with the general controls of the FD&C Act, the Verigene® Gram Positive Blood Culture Nucleic Acid Test is subject to the following special controls: The special controls for the BC-GP Assay are contained in the guideline document entitled "Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures."

*Classification.* Class II (special controls). The special control for this device is FDA's guideline document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures.” For availability of the guideline document, see § 866.1(e).

## Predicate Devices

- Verigene Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test ([K122514](/device/K122514.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number
K243490

B Applicant
Luminex Corporation

C Proprietary and Established Names
LIAISON PLEX Gram-Positive Blood Culture Assay

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  PAM | Class II | 21 CFR 866.3365 - Multiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures | MI - Microbiology  |

## II Submission/Device Overview:

A Purpose for Submission:
The purpose of this submission is to obtain a substantial equivalence determination for the LIAISON PLEX Gram Positive Blood Culture Assay

B Measurand:
Nucleic acids from Bacillus spp., Enterococcus faecalis, Enterococcus faecium, Listeria spp., Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococcus anginosus group, Streptococcus pneumoniae and Streptococcus pyogenes organisms, and mecA/mecC, vanA, and vanB resistance markers.

C Type of Test:
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

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A qualitative multiplexed nucleic acid test intended for use with the automated LIAISON PLEX instrument for the qualitative in vitro detection and identification of gram-positive bacteria in a positive blood culture media sample that demonstrates the presence of gram-positive bacteria as determined by Gram stain.

## Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) for Use:
The LIAISON PLEX Gram-Positive Blood Culture (BCP) Assay, performed using the automated, sample-to-result LIAISON PLEX System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-positive pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles. The LIAISON PLEX BCP Assay is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria as determined by Gram stain.

The LIAISON PLEX BCP Assay detects and identifies the following:

**Gram Positive Resistance Markers (a):**

- mecA/mecC
- vanA
- vanB

**Genera and Species:**

- Bacillus spp.
- Enterococcus faecalis
- Enterococcus faecium
- Listeria spp.
- Staphylococcus spp.
- Staphylococcus aureus
- Staphylococcus epidermidis
- Staphylococcus lugdunensis
- Streptococcus spp.
- Streptococcus agalactiae
- Streptococcus anginosus group
- Streptococcus pneumoniae
- Streptococcus pyogenes

**(a)** Negative results for antimicrobial resistance genes do not indicate bacterial susceptibility as there are multiple mechanisms that can contribute to resistance

K243490 - Page 2 of 40

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The LIAISON PLEX BCP contains targets for the detection of genetic determinants associated with resistance to methicillin (mecA/mecC) and vancomycin (vanA and vanB) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In mixed growth, the LIAISON PLEX BCP Assay does not specifically attribute vanA/vanB-mediated vancomycin resistance to either *E. faecalis* or *E. faecium*, or mecA/mecC-mediated methicillin resistance to either *Staphylococcus* spp., *S. aureus*, *S. epidermidis* or *S. lugdunensis*.

The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of methicillin and vancomycin resistance exist.

The LIAISON PLEX BCP Assay is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections (BSI). The LIAISON PLEX BCP Assay is not intended to monitor treatment of these infections. Subculturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by LIAISON PLEX BCP Assay, to detect mixed infections that may not be detected by the LIAISON PLEX BCP Assay, for association of antimicrobial resistance genes to a specific organism, or for epidemiological typing.

## C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

For in vitro diagnostic use only

## D Special Instrument Requirements:

LIAISON PLEX Instrument and LIAISON PLEX BCP Assay Software version 1.3

## IV Device/System Characteristics:

## A Device Description:

The LIAISON PLEX Gram-Positive Blood Culture Assay (BCP Assay) is an automated test for the detection and identification of nucleic acid from gram-positive bacteria in a positive blood culture media sample. The BCP Assay is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system, and which contain gram-positive bacteria, as determined by a Gram stain.

The LIAISON PLEX System is a fully automated, bench-top "sample-to-answer" device that performs sample preparation, polymerase chain reaction (PCR) and microarray-based hybridization for the detection of target-specific nucleic acids. The test reagents are supplied as a single, disposable test cartridge, including disposable Assay Transfer Pipette Tips.

The LIAISON PLEX BCP Assay has 16 different reportable targets. Reporting of these targets is based on detection of one or more of the nucleic acid targets. Results can be:

- reviewed by the user on the touch-screen;
- exported to as USB flash drive; and,

K243490 - Page 3 of 40

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- printed or submitted to a Laboratory Information System (LIS) for reporting.

## B Principle of Operation:

The LIAISON PLEX Gram-Positive Blood Culture Assay (BCP Assay) is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system, and which contain gram-positive bacteria, as determined by a Gram stain. The system consists of an instrument and a single-use, disposable test cartridge. The user loads an aliquot of the sample into the sample port of the LIAISON PLEX Gram-Positive Blood Culture Assay Cartridge. Next, the user sets up the sample order on the LIAISON PLEX System by first entering the sample information or scanning the barcode ID located on the sample tube, then scanning the barcode ID located on the test cartridge. Last, the user inserts the test cartridge into the processing module to initiate the test. The LIAISON PLEX System identifies the assay being run and automatically initiates the proper testing protocol to process the sample, analyze the data, and generate test results.

The LIAISON PLEX System automates the BCP Assay sample analysis through the following steps:

a) Sample Preparation: Nucleic acid extraction via mechanical and chemical cell lysis and magnetic bead-based nucleic acid isolation; PCR amplification is not used in this assay. By performing direct detection, the assay specifically detects the viable bacteria and minimizes interference from trace nucleic acids or non-viable bacteria that may be present at much lower levels and potentially lead to false positive results.

b) Hybridization: Extracted nucleic acid hybridize to target-specific capture DNA on a microarray format, and target-specific mediator and gold nanoparticle probe hybridize to captured nucleic acids; c) Signal Analysis: Gold nanoparticle probes bound specifically to target-containing spots in the microarray are silver-enhanced, and light scatter from the spots is measured and further analyzed to determine the presence (Detected) or absence (Not Detected) of a target.

The system completes all necessary steps for the assay. No user intervention is necessary once the run is initiated. Once the run is complete, the user removes the cartridge(s) and disposes of them in the appropriate waste container. Following a series of quality control checks a final call is made for the Target: Detected if the Target signal is above threshold and Not Detected otherwise. Failure of any quality control checks results in a "No Call" result.

## C Instrument Description Information:

1. Instrument Name:

LIAISON Plex Systems

2. Specimen Identification:

Specimen identification information is entered either manually or via barcode.

K243490 - Page 4 of 40

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K243490 - Page 5 of 40

3. Specimen Sampling and Handling:

Blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria as determined by a Gram stain.

4. Calibration:

LIAISON PLEX modules are calibrated during the manufacturing process; calibration is not performed by the user.

5. Quality Control:

**Internal Controls:** LIAISON PLEX BCP Assay cartridge incorporates multiple controls to confirm proper test performance, including two internal processing controls (extraction and hybridization controls) that are designed to monitor effectiveness of the specimen processing and hybridization steps. The extraction control is present in the lysis tube of the assay cartridge and functions to assess extraction, nucleic acid isolation, and fragmentation steps of the assay workflow on the cartridge. The hybridization control is present in the sample buffer and added after nucleic acid extraction step and serves as an indicator of successful hybridization step.

A “No Call” is reported based on the BCP Assay specific call logic for internal controls implemented in the assay file. Internal processing controls must generate a signal above the predetermined threshold in each internal reaction for the system to report a valid test result. It is recommended to repeat the test associated with a “No Call” result per the instructions for use.

**External Controls:** External controls are not provided with the LIAISON Plex BCP Assay. However, six external control mixes were provided to the clinical study sites for daily testing during the prospective clinical study. External controls were tested on each day of testing, utilizing one external negative control and one of five external positive controls (tested on a rotating basis) representing all of the LIAISON Plex BCP targets.

V Substantial Equivalence Information:

A Predicate Device Name(s):

Verigene Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test

B Predicate 510(k) Number(s):

K122514

C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K243490 | K122514  |
| --- | --- | --- |
|  Device Trade Name | LIAISON PLEX Gram Positive Blood Culture (BCP) Assay | Verigene Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test  |

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K243490 - Page 6 of 40
|  General Device Characteristic Similarities |  |   |
| --- | --- | --- |
|  Intended Use/Indications For Use | The LIAISON PLEX Gram-Positive Blood Culture (BCP) Assay, performed using the automated, sample-to-result LIAISON PLEX System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-positive pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles. The LIAISON PLEX BCP Assay is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria as determined by Gram stain.

The LIAISON PLEX BCP Assay detects and identifies the following:
Resistance Markers^{a}
mecA/mecC
vanA
vanB
Genera and Species
Bacillus spp.
Enterococcus faecalis
Enterococcus faecium
Listeria spp.
Staphylococcus spp.
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus lugdunensis
Streptococcus spp.
Streptococcus agalactiae
Streptococcus anginosus group
Streptococcus pneumoniae
Streptococcus pyogenes | The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.

BC-GP detects and identifies the following:
Bacterial Genera and Species
Staphylococcus spp.
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus lugdunensis
Streptococcus spp.
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus agalactiae
Streptococcus anginosus group
Enterococcus faecalis
Enterococcus faecium
Listeria spp.
Resistance Markers1
mecA
vanA
vanB
1In mixed growth, BC-GP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis.

BC-GP is indicated for use in conjunction with other  |

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K243490 - Page 7 of 40

|   | *Negative results for antimicrobial resistance genes do not indicate bacterial susceptibility as there are multiple mechanisms that can contribute to resistance. | clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GP, differentiation of mixed growth, for association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.  |
| --- | --- | --- |
|   | The LIAISON PLEX BCP contains targets for the detection of genetic determinants associated with resistance to methicillin (mecA/mecC) and vancomycin (vanA and vanB) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In mixed growth, the LIAISON PLEX BCP Assay does not specifically attribute vanA/vanB-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA/mecC-mediated methicillin resistance to either Staphylococcus spp., S. aureus, S. epidermidis or S. lugdunensis. |   |
|   | The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of methicillin and vancomycin resistance exist. |   |
|   | The LIAISON PLEX BCP Assay is indicated for use in conjunction with other clinical and laboratory findings to aid in the |   |

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K243490 - Page 8 of 40
|   | diagnosis of bacterial bloodstream infections (BSI). The LIAISON PLEX BCP Assay is not intended to monitor treatment of these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by LIAISON PLEX BCP Assay, to detect mixed infections that may not be detected by the LIAISON PLEX BCP Assay, for association of antimicrobial resistance genes to a specific organism, or for epidemiological typing. |   |
| --- | --- | --- |
|  Measurand | Target DNA sequences of gram-positive bacteria and antimicrobial resistance markers | Same  |
|  Specimen Type | Positive blood culture (PBC) samples that contain gram-positive bacteria. | Same  |
|  Sample Extraction | Chemical and mechanical lysis followed by a chaotrope-based nucleic acid isolation procedure | Same  |
|  Quality Controls | Two internal processing controls (extraction and hybridization controls). External controls are recommended to be run | Same  |
|  Test Interpretation Output | Detected/Not Detected | Same  |
|  General Device Characteristic Differences |  |   |
|  Organisms Detected | Bacillus spp.
Enterococcus faecalis
Enterococcus faecium
Listeria spp.
Staphylococcus spp.
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus lugdunensis
Streptococcus spp.
Streptococcus agalactiae
Streptococcus anginosus group | Staphylococcus spp.
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus lugdunensis
Streptococcus spp.
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus agalactiae
Streptococcus anginosus group
Enterococcus faecalis
Enterococcus faecium  |

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VI Standards/Guidance Documents Referenced:

|  Document ID | Title  |
| --- | --- |
|  Class II Special Controls Guideline | Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures (May 2015)  |
|  Guidance document | Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff (October 2, 2023).  |
|  Guidance document | Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff (June 14, 2023).  |
|  Guidance document | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff (September 23, 2023).  |
|  Guidance document | Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff (March 13, 2007).  |
|  CLSI document EP25-A | Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline  |
|  ISO 14971:2019 | Medical devices -Application of risk management to medical devices  |
|  IEC 62366-1:2015 +A1:2020 | Medical devices -Part 1: Application of usability engineering to medical devices  |
|  ISO 62304:2006 | Medical device software -Software life-cycle processes  |
|  ISO 15223-1:2021: | Medical Devices -Symbols to be used with medical device labels, labeling and information to be supplied -Part 1: General requirements  |
|  IEC 61010-1 Ed. 3.1 2017-01 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements  |
|  EN 61010-2-101:2002/IEC 61010-2-101:2015 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment  |
|  IEC 60601-1-2:2014 (Edition 4.0) | Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests  |
|  ISO 13485:2016/EN ISO 13485:2016 | Medical devices -Quality Management System -Requirements for regulatory purposes  |
|  ISO 20916:2019 | In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice  |
|  EN ISO 18113-1:2011 | In vitro diagnostic medical devices -Information supplied by the manufacturer (labeling). Terms, definition and general requirements  |
|  EN ISO 18113-2:2011 | In vitro diagnostic medical devices -Information supplied by the manufacturer (labeling) - Part 2: In vitro diagnostic reagents for professional use  |
|  EN ISO 18113-3:2011 | In vitro diagnostic medical devices -Information supplied by the manufacturer (labeling) - Part 3: In vitro diagnostic instruments for professional use  |
|  EN ISO 23640:2015 | In vitro diagnostic medical devices -Evaluation of stability of in vitro diagnostic reagents  |
|  IEC 61326-1:2012 | Electrical equipment for measurement control and laboratory use -EMC requirements -Part 1: General requirements  |
|  EN 61326-2-6:2006/IEC 61326-2-6:2012 | Electrical equipment for measurement control and laboratory use -EMC requirements -Part 2-6: Particular requirements -In vitro diagnostic (IVD) medical equipment  |

VII Performance Characteristics (if/when applicable):

K243490 - Page 9 of 40

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# A Analytical Performance:

1. Precision/Reproducibility: A sample panel was prepared containing seven representative on-panel organisms prepared at ring-positive (RP) and ring-positive + 8 hours concentrations. Additionally, one negative sample contrived with an off-panel organism (Escherichia coli), and one negative blood culture matrix were also prepared. Assay reproducibility was evaluated in a study conducted across three different sites, for five days, with two runs and three replicates per run. A total of 90 replicates were evaluated for each tested analyte in each panel member.

Results from the reproducibility study are summarized below (Table 1).

Table 1 Reproducibility Study Results

|  Organism ID | Reportable Targets | Sample Type | Agreement (%) with Expected results |   |   | % Agreement All sites [95% CI]  |
| --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  Site1 | Site 2 | Site 3  |   |
|  Staphylococcus aureus | Staphylococcus spp. | Panel 1 - RP | 100% (30/30) | 100% (30/30) | 100% (30/30) | (90/90) 100% [95.9%-100%]  |
|   |   |  Panel 1 - RP+8 Hours | 100% (30/30) | 96.7% (29/30)a | 100% (30/30) | (89/90) 98.9% [94.0%-99.8%]  |
|  Staphylococcus aureus | Staphylococcus aureus | Panel 1 - RP | 100% (30/30) | 100% (30/30) | 100% (30/30) | (90/90) 100% [95.9%-100%]  |
|   |   |  Panel 1 - RP+8 Hours | 100% (30/30) | 96.7% (29/30)a | 100% (30/30) | (89/90) 98.9% [94.0%-99.8%]  |
|  Enterococcus faecalis | Enterococcus faecalis | Panel 2 - RP | 100% (30/30) | 100% (30/30) | 100% (30/30) | (90/90) 100% [95.9%-100%]  |
|   |   |  Panel 2 - RP+8 Hours | 100% (30/30) | 100% (30/30) | 100% (30/30) | (90/90) 100% [95.9%-100%]  |
|  Bacillus subtilis | Bacillus spp. | Panel 3 - RP | 100% (30/30) | 100% (30/30) | 100% (30/30) | (90/90) 100% [95.9%-100%]  |
|   |   |  Panel 3 - RP+8 Hours | 100% (30/30) | 100% (30/30) | 100% (30/30) | (90/90) 100% [95.9%-100%]  |
|  Listeria monocytogenes | Listeria spp. | Panel 4 - RP | 100% (30/30) | 100% (30/30) | 96.7% (29/30)c | (89/90) 98.9% [94.0%-99.8%]  |
|   |   |  Panel 4 - RP+8 Hours | 100% (30/30) | 100% (30/30) | 100% (30/30) | (90/90) 100% [95.9%-100%]  |
|  Staphylococcus epidermidis | Staphylococcus spp. | Panel 5 - RP | 100% (30/30) | 100% (30/30) | 100% (30/30) | (90/90) 100% [95.9%-100%]  |

K243490 - Page 10 of 40

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K243490 - Page 11 of 40
|   |  | Panel 5
– RP+8
Hours | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
| --- | --- | --- | --- | --- | --- | --- |
|  Staphylococcus
epidermidis | Staphylococcus
epidermidis | Panel 5
– RP | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
|   |   |  Panel 5
– RP+8
Hours | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
|  Streptococcus
pneumoniae | Streptococcus spp. | Panel 6
– RP | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
|   |   |  Panel 6
– RP+8
Hours | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
|  Streptococcus
pneumoniae | Streptococcus
pneumoniae. | Panel 6
– RP | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
|   |   |  Panel 6
– RP+8
Hours | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
|  Streptococcus
pyogenes | Streptococcus spp. | Panel 7
– RP | 100%
(30/30) | 100%
(30/30) | 96.7%
(29/30)^{d} | (89/90)
98.9%
[94.0%-99.8%]  |
|   |   |  Panel 7
– RP+8
Hours | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
|  Streptococcus
pyogenes | Streptococcus
pyogenes | Panel 7
– RP | 100%
(30/30) | 100%
(30/30) | 96.7%
(29/30)^{d} | (89/90)
98.9%
[94.0%-99.8%]  |
|   |   |  Panel 7
– RP+8
Hours | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
|  Escherichia
coli | None | Contrived
Negative | 100%
(60/60) | 100%
(60/60) | 100%
(60/60) | (180/180)
100%
[97.9%-100%]  |
|  No Target | None | Negative
Blood
Matrix | 100%
(30/30) | 100%
(30/30) | 96.7%
(29/30)^{b} | (89/90)
98.9%
[94.0%-99.8%]  |
|  Staphylococcus
aureus | mecA/mecC | Panel 1
– RP | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
|   |   |  Panel 1
– RP+8
Hours | 100%
(30/30) | 96.7%
(29
^{a}/30) | 100%
(30/30) | (89/90)
98.9%
[94.0%-99.8%]  |
|  Enterococcus
faecalis | vanB | Panel 2
– RP | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |
|   |   |  Panel 2
– RP+8
Hours | 100%
(30/30) | 100%
(30/30) | 100%
(30/30) | (90/90)
100%
[95.9%- 100%]  |

{11}

|  Staphylococcus epidermidis | mecA/mecC | Panel 5 – RP | 100% (30/30) | 100% (30/30) | 100% (30/30) | (90/90) 100% [95.9%- 100%]  |
| --- | --- | --- | --- | --- | --- | --- |
|   |   |  Panel 5 – RP+8 Hours | 100% (30/30) | 100% (30/30) | 100% (30/30) | (90/90) 100% [95.9%- 100%]  |

a False positive S. lugdunensis, S. anginosus group, and Streptococcus spp. result in 1/30 replicates. Reportable targets were all detected.
b False positive E. faecium and vanA result in 1/30 replicates.
c False positive S. lugdunensis result in 1/30 replicates. Reportable targets were all detected.
d False positive Staphylococcus spp. result in 1/30 replicates. Reportable targets were all detected.

Precision and Repeatability: Within-laboratory precision was evaluated by testing a panel of samples containing two representative on-panel organisms at ring-positive and ring-positive +8 hours concentrations. Additionally, one contrived negative sample containing an off-panel organism and one negative blood culture sample were also evaluated. Samples were tested in one site, using one reagent lot. Percent agreement with expected results was calculated for each analyte at each tested concentration. Results are summarized in Table 2, below.

Table 2. Precision/Repeatability Study Results

|  Organism ID | Reportable Targets | Sample Type | Agreement (%) with Expected results | Overall 95% CI  |
| --- | --- | --- | --- | --- |
|  Staphylococcus aureus | Staphylococcus spp | Panel 1 – RP | 100% (30/30) | 88.6% - 100%  |
|   |   |  Panel 1 – RP+8 Hours | 100% (30/30) | 88.6% - 100%  |
|  Staphylococcus aureus | Staphylococcus aureus | Panel 1 – RP | 100% (30/30) | 88.6% - 100%  |
|   |   |  Panel 1 – RP+8 Hours | 100% (30/30) | 88.6% - 100%  |
|  Enterococcus faecalis | Enterococcus faecalis | Panel 2 – RP | 100% (30/30) | 88.6% - 100%  |
|   |   |  Panel 2 – RP+8 Hours | 100% (30/30) | 88.6% - 100%  |
|  Escherichia coli | None | Contrived Negative | 100% (30/30) | 88.6% - 100%  |
|  No Target | None | Negative Blood Matrix | 100% (30/30) | 88.6% - 100%  |
|  Resistance Marker genes  |   |   |   |   |
|  Staphylococcus aureus | mecA/mecC | Panel 1 – RP | 100% (30/30) | 88.6% - 100%  |
|   |   |  Panel 1 – RP+8 Hours | 100% (30/30) | 88.6% - 100%  |
|  Enterococcus faecalis | vanB | Panel 1 – RP | 100% (30/30) | 88.6% - 100%  |
|   |   |  Panel 1 – RP+8 Hours | 100% (30/30) | 88.6% - 100%  |

Lot-to-Lot variability: Lot-to-Lot reproducibility was evaluated during five non-consecutive days using three lots of cartridges and four LIAISON PLEX Systems. A sample panel of six blood culture samples including two on-panel representative organisms at both ring-positive and ring positive +8 hours concentrations was evaluated. Additionally, one negative contrived sample

K243490 - Page 12 of 40

{12}

containing an off-panel organism and a negative blood culture sample were also tested. Each sample was tested in triplicate per cartridge lot on a given testing day. Between-lot percentage agreement was calculated as seen in Table 3, below.

Table 3 Lot-to-Lot Reproducibility Results

|  Organism ID | Reportable Targets | Sample Type | Reagent Lot | Results (% agreement) | Results (95% CI)  |
| --- | --- | --- | --- | --- | --- |
|  Staphylococcus aureus | Staphylococcus spp | Panel 1 - RP | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |
|   |   |   |  Overall | 100% (45/45) | 92.1% - 100%  |
|   |   |  Panel 1 - RP+8 Hours | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |
|   |   |   |  Overall | 100% (45/45) | 92.1% - 100%  |
|  Staphylococcus aureus | Staphylococcus aureus | Panel 1 - RP | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |
|   |   |   |  Overall | 100% (45/45) | 92.1% - 100%  |
|   |   |  Panel 1 - RP+8 Hours | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |
|   |   |   |  Overall | 100% (45/45) | 92.1% - 100%  |
|  Enterococcus faecalis | Enterococcus faecalis | Panel 2 - RP | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |
|   |   |   |  Overall | 100% (45/45) | 92.1% - 100%  |
|   |   |  Panel 2 - RP+8 Hours | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |
|   |   |   |  Overall | 100% (45/45) | 92.1% - 100%  |
|  Escherichia coli | None | Contrived Negative | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |
|   |   |   |  Overall | 100% (45/45) | 92.1% - 100%  |
|  No Target | None | Negative Blood Matrix | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |
|   |   |   |  Overall | 100% (45/45) | 92.1% - 100%  |
|  Resistance Marker  |   |   |   |   |   |
|  Staphylococcus aureus | mecA/mecC | Panel 1 - RP | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |
|   |   |   |  Overall | 100% (45/45) | 92.1% - 100%  |
|   |   |  Panel 1 - RP+8 Hours | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |
|   |   |   |  Overall | 100% (45/45) | 92.1% - 100%  |
|  Enterococcus faecalis | vanB | Panel 2 - RP | Lot 1 | 100% (15/15) | 79.6% - 100%  |
|   |   |   |  Lot 2 | 100% (15/15)  |   |
|   |   |   |  Lot 3 | 100% (15/15)  |   |

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K243490 - Page 14 of 40

2. Linearity:

Not applicable as the candidate device is a qualitative assay.

3. Analytical Specificity/Interference:

Analytical Specificity/Cross-reactivity: To evaluate potential cross-reactivity of the LIAISON BCP assay, 92 off-panel organisms were evaluated by wet testing. The study included organisms phylogenetically related to the on-panel organisms, and organisms that are likely to be present in typical blood culture samples but are not detected by the candidate assay. All organisms were tested at the highest clinically relevant concentration. The evaluation determined that of the 9 tested organisms, 86 did not cross-react with the candidate assay's targets (Table 4). However, five organisms cross-reacted with target organisms in the candidate panel, and one organism showed positivity in 1/6 replicates tested, as seen in Table 5, below.

Table 4: Cross-Reactivity Study Results

|  Organism | Positivity | Organism | Positivity  |
| --- | --- | --- | --- |
|  Gram Positive  |   |   |   |
|  Abitrophia defectiva | 0% | Erysipelothrix rhusiopathiae | 0%  |
|  Aerococcus viridans | 0% | Kocuria kristinae | 0%  |
|  Arcanobacterium bernardiae | 0% | Kytococcus sedentarius, methicillin resistant | 0%  |
|  Arcanobacterium haemolyticum | 0% | Lactobacillus acidophilus | 0%  |
|  Cutibacterium avidum | 0% | Lactobacillus crispatus | 0%  |
|  Propionibacterium freudenreichii | 0% | Lactobacillus rhamnosus | 0%  |
|  Enterococcus avium | 100% | Leuconostoc carnosum | 100%  |
|  Enterococcus casseliflavis, VRE, vanC | 0% | Leuconostoc mesenteroides | 0%  |
|  Enterococcus dispar | 0% | Pediococcus acidilactici | 0%  |
|  Enterococcus durans | 0% | Pediococcus pentosaceus | 0%  |
|  Enterococcus flavescens | 0% | Peptostreptococcus anaerobius | 0%  |
|  Enterococcus gallinarum, vanC | 0% | Planococcus citreus | 0%  |
|  Enterococcus hirae | 0% | Planococcus kocurii | 0%  |
|  Enterococcus mundtii | 0% | Rothia dentocariosa | 0%  |
|  Enterococcus raffinosus | 0% | Rothia (Stomatococcus) mucilaginosa | 0%  |
|  Gram Negative  |   |   |   |
|  Acinetobacter calcoaceticus | 0% | Haemophilus influenzae | 0%  |
|  Acinetobacter pittii | 0% | Herbaspirillum huttiense | 0%  |
|  Aggregatibacter aphrophilus | 100% | Kingella kingae | 0%  |
|  Bacteroides fragilis | 0% | Klebsiella oxytoca | 0%  |
|  Brevundimonas diminuta | 0% | Klebsiella pneumoniae | 0%  |
|  Burkholderia cepacia | 0% | Klebsiella variicola | 0%  |
|  Cardiobacterium hominis | 0% | Leclercia adecarboxylata | 0%  |
|  Cedecea lapagei | 0% | Moraxella catarrhalis | 0%  |

{14}

Table 5. Cross-reactive Organisms Observed in Wet-testing.

|  Panel Target Organism | Predicted potential Cross-Reacting Organisms (false positive for the target organism)  |
| --- | --- |
|  Streptococcus spp. | - Leuconostoc carnosum - Aggregatibacter aphrophilus - Proteus penneri - Proteus vulgaris  |
|  Enterococcus faecium | - Enterococcus avium  |

In Silico Exclusivity (Cross-Reactivity): In silico analysis was conducted to predict potential cross-reactivity of the LIAISON BCP assay oligos through a BLAST comparison of the oligo sequences to the GenBank nucleotide sequence database. The analysis was performed with all capture and mediator probes in the assay, including the internal control oligos, for organisms that could not be wet tested. In silico exclusivity assessment of the oligo sequences incorporated in the assay were compared to on-panel and off-panel organisms listed in Table 6 Organisms identified as potentially cross-reactive as the in-silico analysis are summarized in Table 7, below.

Table 6. Organisms Evaluated for Cross-reactivity by in silico Analysis.

|   | Off-Panel Organisms  |
| --- | --- |

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K243490 - Page 16 of 40
|  On Panel Organisms | Gram-Positive Bacteria | Gram-Negative Bacteria | Resistance Markers | Yeast/Virus/Parasites  |
| --- | --- | --- | --- | --- |
|  Bacillus spp. | Abiotrophia defectiva | Acinetobacter spp. | AmpC | Aspergillus flavus  |
|  Enterococcus faecalis | Actinomyces israelii | Actinobacillus hominis | CMY | Aspergillus fumigatus  |
|  Enterococcus faecium | Actinomyces naeslundii | Actinobacillus ureae | CTX-M | Aspergillus niger  |
|  Listeria spp. | Actinomyces odontolyticus | Aeromonas caviae | IMP | Aspergillus terreus  |
|  Staphylococcus aureus | Aerococcus sanguinicola | Aeromonas hydrophila | KPC | Blastomyces dermatitidis  |
|  Staphylococcus epidermidis | Aerococcus urinae | Aeromonas sobria | MCR | Candida albicans  |
|  Staphylococcus lugdunensis | Aerococcus viridans | Aggregatibacter actinomycetemcomitans | NDM | Candida auris  |
|  Staphylococcus spp. | Arcanobacterium bernardiae | Aggregatibacter aphrophilus | ompK36 | Candida dubliniensis  |
|  Streptococcus agalactiae | Arcanobacterium haemolyticum | Bacteroides caccae | OXA | Candida famata  |
|  Streptococcus anginosus group | Arthrobacter psychrolactophilus | Bacteroides fragilis | RAHN | Candida glabrata  |
|  Streptococcus pneumoniae | Brochothrix thermosphacta | Bacteroides ovatus | SHV | Candida guilliermondii  |
|  vanB | Carnobacterium divergens | Bacteroides thetaiotaomicron | SME | Candida haemulonii  |
|   | Carnobacterium maltaromaticum | Bacteroides uniformis | SPM | Candida inconspicua  |
|   |  Clostridium perfringens | Brevundimonas diminuta |  | Candida multis-gemmis  |
|   |  Clostridium ramosum (Thomasclavelia ramosa) | Brevundimonas vesicularis |   | Candida nivariensis  |
|   |  Clostridium septicum | Clostridium septicum |   | Candida norvegensis  |
|   |  Clostridium tertium | Burkholderia mallei |   | Candida orthopsilosis  |
|   |  Clostridium tetani | Burkholderia multivorans |   | Candida parapsilosis  |
|   |  Cutibacterium avidum | Burkholderia pseudomallei |   | Candida sojae  |
|   |  Cutibacterium granulosum | Campylobacter hominis |   | Candida tropicalis  |
|   |  Enterococcus avium | Capnocytophaga ochracea |   | Candida duobushaemulonii  |
|   |  Enterococcus casseliflavus | Cardiobacterium hominis |   | Candida viswanathii  |
|   |  Enterococcus cecorum | Chlamydia trachomatis |   | Coccidioides immitis  |
|   |  Enterococcus dispar | Chlamydophila pneumoniae |   | Coccidioides posadasii  |
|   |  Enterococcus durans | Chromobacterium violaceum |   | Cryptococcus amylolentus  |
|   |  Enterococcus flavescens | Citrobacter spp. |   | Cryptococcus gattii  |

{16}

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|   | Enterococcus gallinarum | Comamonas testosteroni |  | Cryptococcus neoformans  |
| --- | --- | --- | --- | --- |
|   | Enterococcus hirae | Delftia acidovorans |  | Cryptococcus uniguttulatus  |
|   | Enterococcus mundtii | Eikenella corrodens |  | Cutaneotrichosporon curvatum  |
|   | Enterococcus raffinosus | Elizabethkingia meningoseptica |  | Cyberlindnera fabianii  |
|   | Erysipelothrix rhusiopathiae | Enterobacter spp. |  | Geotrichum capitatum (Magnusiomyces capitatus)  |
|   | Finegoldia magna | Enterobacteriaceae |  | Histoplasma capsulatum  |
|   | Gemella haemolysans | Escherichia coli |  | Kluyveromyces lactis  |
|   | Gemella morbillorum | Fusobacterium necrophorum |  | Kodamaea ohmeri  |
|   | Gemella morbillorum | Fusobacterium necrophorum |  | Kodamaea ohmeri  |
|   | Globicatella spp. | Fusobacterium nucleatum |  | Lodderomyces elongisporus  |
|   | Granulicatella adiacens | Haemophilus influenzae |  | Magnusiomyces capitatus  |
|   | Granulicatella elegans | Haemophilus aegyptius |  | Millerozyma farinosa  |
|   | Kocuria kristinae | Haemophilus ducreyi |  | Naganishia albida  |
|   | Kocuria rhizophila | Haemophilus haemolyticus |  | Papiliotrema laurentii  |
|   | Kytococcus sedentarius | Haemophilus parahaemolyticus |  | Penicillium chrysogenum  |
|   | Lactobacillus acidophilus | Haemophilus parainfluenzae |  | Rhodotorula mucilaginosa  |
|   | Lactobacillus rhamnosus | Haemophilus quentini |  | Schizosaccharomyces pombe  |
|   | Lactococcus garvieae | Haemophilus sputorum |  | Talaromyces marneffei  |
|   | Lactococcus lactis | Herbaspirillum huttiense |  | Trichosporon asahii  |
|   | Leuconostoc carnosum | Kingella denitrificans |  | Wickerhamomyces anomalus  |
|   | Leuconostoc citreum | Kingella kingae |  | BK Virus  |
|   | Leuconostoc mesenteroides | Kingella negevensis |  | Chikungunya Virus  |
|   | Macrococcus caseolyticus | Kingella oralis |  | Cytomegalovirus  |
|   | Micrococcus luteus | Klebsiella oxytoca |  | Dengue Virus  |
|   | Mycobacterium avium complex (MAC) | Klebsiella pneumoniae |  | Enterovirus  |
|   | Mycobacterium fortuitum | Klebsiella variicola |  | Epstein Barr Virus  |
|   | Mycobacterium mucogenicum | Legionella pneumophila |  | Hepatitis A virus  |
|   | Mycoplasma hominis | Leptospira interrogans |  | Hepatitis B virus  |
|   | Mycoplasma pneumoniae | Moraxella catarrhalis |  | Hepatitis C virus  |
|   | Nocardia farcinica | Moraxella osloensis |  | Human alphaherpesvirus 1  |
|   | Parvimonas micra | Morganellaceae |  | Human alphaherpesvirus 2  |
|   | Pediococcus acidilactici | Mycobacterium tuberculosis |  | Human betaherpesvirus 6  |
|   | Pediococcus pentosaceus | Neisseria gonorrhoeae |  | Human betaherpesvirus 7  |
|   | Peptostreptococcus anaerobius | Neisseria lactamica |  | Human Immunodeficiency Virus  |

{17}

Table 7. Cross-reactive Organisms Predicted by in silico Analysis.

|  Panel Target Organism | Predicted potential Cross-Reacting Organisms (False Positive for the Target Organism)  |
| --- | --- |
|  Enterococcus faecalis | - Some strains of Enterococcus durans - Three strains of Streptococcus spp. (AY123726.1, FJ577604.1, MK608388.1)  |
|  Enterococcus faecium | - One strain of Enterococcus durans (KT877992.1) - One strain of Enterococcus faecalis (CP092577.1)  |

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Analytical Reactivity/Inclusivity: The analytical reactivity of the LIAISON BCP assay was evaluated using a collection of 209 isolates representing the genetic diversity of the analytes (Table 8) and antimicrobial resistance markers (Table 9) included in the panel.

Table 8. Analytical Reactivity (Inclusivity) Study Results Summary by Organism

|  Reportable Target (Genus) | Reportable Target (Species) | Organism | # of Strains | % Detected  |
| --- | --- | --- | --- | --- |
|  Bacillus spp. | N/A | B. cereus | 4 | 100%  |
|   |   |  B. licheniformis | 2 | 100%  |
|   |   |  B. subtilis | 3 | 100%  |
|   |   |  B. thuringiensis | 2 | 100%  |
|  Corynebacterium spp. | N/A | C. amycolatum | 3 | 100%  |
|   |   |  C. diphtheriae | 3 | 100%  |
|   |   |  C. flavescens | 1 | 100%  |
|   |   |  C. genitalium | 1 | 100%  |

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K243490 - Page 20 of 40
|   |  | C. glutamicum | 2 | 100%  |
| --- | --- | --- | --- | --- |
|   |  | C. jeikeium | 2 | 100%  |
|   |  | C pseudodiphthericum | 2 | 100%  |
|   |  | C. renale | 2 | 100%  |
|   |  | C. striatum | 3 | 100%  |
|   |  | C. urealyticum | 1 | 100%  |
|  N/A | Enterococcus faecalis | E. faecalis | 9 | 100%  |
|   | Enterococcus faecium | E. faecium | 9 | 100%^{a}  |
|  Listeria spp. | N/A | L. grayi | 2 | 100%  |
|   |  | L. innocua | 2 | 100%  |
|   |  | L. ivanovii | 2 | 100%  |
|   |  | L. monocytogenes | 6 | 100%  |
|   |  | L. seeligeri | 2 | 100%  |
|   |  | L. welshimeri | 2 | 100%  |
|  Staphylococcus spp. | Staphylococcus aureus | S. aureus | 43 | 100%  |
|   | Staphylococcus epidermidis | S. epidermidis | 8 | 100%  |
|   | Staphylococcus lugdunensis | S. lugdunensis | 5 | 100%  |
|   | N/A | S. argenteus | 2 | 100%^{c}  |
|   |  | S. auricularis | 2 | 100%  |
|   |  | S. capitis | 2 | 100%  |
|   |  | S. caprae | 1 | 100%  |
|   |  | S. cohnii | 2 | 100%  |
|   |  | S. haemolyticus | 2 | 100%  |
|   |  | S. hominis | 3 | 100%  |
|   |  | S. intermedius | 2 | 100%  |
|   |  | S. muscae | 1 | 100%^{b}  |
|   |  | S. pasteuri | 1 | 100%  |
|   |  | S. saccharolyticus | 3 | 100%  |
|   |  | S. saprophyticus | 2 | 100%  |
|   |  | S. schleiferi | 1 | 100%  |
|   |  | S. sciuri | 2 | 100%  |
|   |  | S. stimulans | 2 | 100%  |
|   |  | S. warneri | 2 | 100%  |
|   |  | S. xylosus | 1 | 100%  |
|  Streptococcus spp. | Streptococcus agalactiae | S. agalactiae | 5 | 100%  |
|   | Streptococcus anginosus group | S. anginosus | 2 | 100%  |
|   |  | S. constellatus | 3 | 100%  |
|   |  | S. intermedius | 2 | 100%  |
|   | Streptococcus pneumoniae | S. pneumoniae | 5 | 100%  |
|   | S. pyogenens | S. pyogenes | 5 | 100%  |
|   | N/A | S. bovis | 3 | 100%  |
|   |  | S. dysagalactiae | 2 | 100%  |
|   |  | S. equi | 2 | 100%  |
|   |  | S. equinus | 2 | 100%  |
|   |  | S. gallolyticus | 3 | 100%  |
|   |  | S. gordonii | 2 | 100%  |
|   |  | S. infantarius subsp. coli | 1 | 100%  |
|   |  | S. infantis | 2 | 100%  |
|   |  | S. mitis | 2 | 100%  |
|   |  | S. mutans | 2 | 88.9^{d}  |
|   |  | S. oralis | 2 | 100%  |
|   |  | S. parasanguinis | 2 | 100%  |
|   |  | S. peroris | 1 | 100%  |
|   |  | S. pseudoneumoniae | 1 | 100%  |
|   |  | S. salivarius | 1 | 100%  |

{20}

Table 9. Analytical Reactivity (Inclusivity) Results Summary by Resistance Marker

|  Reportable Target | Organism | # of Strains | % Detected  |
| --- | --- | --- | --- |
|  mecA/C | Staphylococcus argenteus | 1 | 100%  |
|  mecA/C | Staphylococcus aureus | 35 | 100%  |
|   |  Staphylococcus epidermidis | 5 | 100%  |
|   |  Staphylococcus hominis | 1 | 100%  |
|   |  Staphylococcus sciuri | 2 | 100%  |
|  vanA | Enterococcus faecalis | 3 | 100%  |
|   |  Enterococcus faecium | 3 | 100%^{a}  |
|  vanB | Enterococcus faecalis | 3 | 100%  |
|   |  Enterococcus faecium | 3 | 100%  |

a One replicate from one strain resulted in a false positive (FP) S. lugdunensis result, three additional replicates were run for that strain. No additional FP results were observed.
b Staphylococcus muscae cross reacts with Listeria spp.
c Staphylococcus argenteus cross reacts with S. aureus.
d One strain of Streptococcus mutans, ATCC 25175, did not detect Streptococcus spp. in one replicate of initial testing. It was run an additional 3 times, giving an overall detection rate of 5/6 for that strain. S. mutans strain 31383 was detected (3/3).

In Silico Inclusivity: An in-silico analysis was conducted using sequences available in the GenBank and WGS databases from March to April 2024 to determine reactivity with organisms not included in the wet testing. Summary of the results can be found in Table 10.

Table 10. Inclusivity in silico Analysis Summary

|  Reportable Target | Inclusive Organism/Target | Total # Sequences in Alignment | # Sequences with percent Oligo Identity ≥90% | Predicted Inclusivity Percentage (%)  |
| --- | --- | --- | --- | --- |
|  Bacillus spp.^{a} | B. cereus group | 6722 | 6718 | 100  |
|   |  B. subtilis group | 4320 | 4318 | 100  |
|  Enterococcus faecalis | E. faecalis | 746 | 745 | 100  |
|  Enterococcus faecium | E. faecium | 555 | 555 | 100  |
|  Listeria spp.^{b} | L. monocytogenes | 8812 | 8812 | 100  |
|   | Other Listeria spp. | 899 | 876 | 97  |
|  Staphylococcus aureus | S. aureus | 2307 | 2307 | 100  |
|  Staphylococcus epidermidis | S. epidermidis | 250 | 250 | 100  |
|  Staphylococcus lugdunensis | S. lugdunensis | 162 | 162 | 100  |
|  Staphylococcus spp.^{c} | Staphylococcus spp. | 13355 | 13354 | 100  |
|  Streptococcus agalactiae | S. agalactiae | 454 | 454 | 100  |
|  Streptococcus anginosus Group | S. anginosus | 356 | 356 | 100  |
|   |  S. constellatus | 70 | 70 | 100  |
|   |  S. intermedius | 127 | 127 | 100  |
|   |  Unspecified species from S. anginosus Group | 7 | 7 | 100  |
|  Streptococcus pneumoniae | S. pneumoniae | 693 | 693 | 100  |
|  Streptococcus pyogenes | S pyogenes | 732 | 732 | 100  |
|  Streptococcus spp.^{d} | Streptococcus spp. | 23589 | 23574 | 100  |

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|  mecA/mecC e | mecA | 2201 | 2158 | 98  |
| --- | --- | --- | --- | --- |
|   |  mecC | 32 | 32 | 100  |
|  vanA f | vanA | 570 | 551 | 97  |
|  vanB f | vanB | 215 | 215 | 100  |

a Includes sequences for 26 species of B. cereus group and 15 species of B. subtilis group. Oligo designs may also detect Bacillus species that are not part of these two groups.
b Includes sequences for 28 Listeria species.
c Includes sequences for 44 Staphylococcus species.
d Includes sequences for 108 Streptococcus species.
e Includes sequences for Staphylococcus species only.
f Includes sequences for E. faecalis and E. faecium only.

Competitive Inhibition: To determine whether coinfection with another target panel organism may impact test results, eight samples containing bottle/ring positive concentrations of on-panel target organisms were combined with other on-panel analytes at bottle/ring positive +8 hours concentrations. The eight total on-panel organisms were selected to be representative of clinically relevant poly-microbial infections in blood culture specimens, as listed in Table 11, below. Expected results for competitive inhibition (co-infection) include 100% positivity for both on-panel organisms present.

Table 11. Competitive Inhibition Study Results

|  On-Panel High Level Analyte | Positivity | On-Panel Low Level Analyte | Positivity  |
| --- | --- | --- | --- |
|  Enterococcus faecalis | 3/3 | Staphylococcus epidermidis | 3/3  |
|   |  3/3 | Enterococcus faecium | 3/3  |
|  Enterococcus faecium | 3/3 | Staphylococcus epidermidis | 3/3  |
|   |  3/3 | Enterococcus faecalis | 3/3  |
|  Staphylococcus aureus | 3/3 | Staphylococcus epidermidis | 3/3  |
|   |  3/3 | Streptococcus agalactiae | 3/3  |
|  Staphylococcus epidermidis | 3/3 | Enterococcus faecalis | 3/3  |
|   |  3/3 | Enterococcus faecium | 3/3  |
|   |  3/3 | Staphylococcus aureus | 3/3  |
|   |  3/3 | Staphylococcus lugdunensis | 3/3  |
|   |  3/3 | Streptococcus pneumoniae | 3/3  |
|  Staphylococcus lugdunensis | 3/3 | Staphylococcus epidermidis | 3/3  |
|  Streptococcus agalactiae | 3/3 | Staphylococcus aureus | 3/3  |
|  Streptococcus pneumoniae | 3/3 | Staphylococcus epidermidis | 3/3  |

Microbial Interference: To evaluate whether microbial interference occurs, samples containing two on-panel organisms at bottle/ring positive concentrations were combined in pairs with three representative off-panel organisms at analyte concentration at bottle/ring positive +8 hours and tested in triplicate. The specific organism sets were selected to mimic potentially interfering micro-organisms that are commonly found in positive blood samples, but which detection is not intended by the LIAISON PLEX BCP Assay. Results are summarized Table 12 below. Expected results for microbial interference include 100% positivity for the on-panel organism in the presence of the off-panel organism.

Table 12. Microbial Interference Study Results

|  On-Panel Low Concentration | Positivity | Off-Panel High Concentration | Positivity  |
| --- | --- | --- | --- |
|  Staphylococcus epidermidis | 3/3 | Escherichia coli | 0/3  |

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Interfering Substances: An interfering substances study was conducted to assess the performance of the LIAISON PLEX BCP Assay in the presence of potentially interfering non-microbial substances that may be present in blood culture specimens. A set of samples containing six representative on-panel target organisms were tested in the presence of six interfering substances across five replicates. A panel containing negative blood matrix was also tested to assess the risk of false positive results in the presence of potentially interfering substances. A positive control (specimen without interfering substances) for all targets was also tested to assess for detection capabilities. No interference from any evaluated substance was observed (Table 13).

Table 13: Interfering Substances Study Results

|  Interfering Substance | Concentration | Target | Positivity  |
| --- | --- | --- | --- |
|  Unconjugated Bilirubin | 20 mg/dL | Staphylococcus aureus | 100%  |
|   |   |  Staphylococcus epidermidis | 100%  |
|   |   |  Streptococcus pneumoniae | 100%  |
|   |   |  Streptococcus agalactiae | 100%  |
|   |   |  Enterococcus faecalis | 100%  |
|   |   |  Enterococcus faecium | 100%  |
|   |   |  Negative blood matrix | 0%  |
|  Conjugated Bilirubin | 20 mg/dL | Staphylococcus aureus | 100%  |
|   |   |  Staphylococcus epidermidis | 100%  |
|   |   |  Streptococcus pneumoniae | 100%  |
|   |   |  Streptococcus agalactiae | 100%  |
|   |   |  Enterococcus faecalis | 100%  |
|   |   |  Enterococcus faecium | 100%  |
|   |   |  Negative blood matrix | 0%  |
|  Hemoglobin | 14 g/L | Staphylococcus aureus | 100%  |
|   |   |  Staphylococcus epidermidis | 100%  |
|   |   |  Streptococcus pneumoniae | 100%  |
|   |   |  Streptococcus agalactiae | 100%  |
|   |   |  Enterococcus faecalis | 100%  |
|   |   |  Enterococcus faecium | 100%  |
|   |   |  Negative blood matrix | 0%  |
|  Intralipid | 3000 mg/dL | Staphylococcus aureus | 100%  |
|   |   |  Staphylococcus epidermidis | 100%  |
|   |   |  Streptococcus pneumoniae | 100%  |
|   |   |  Streptococcus agalactiae | 100%  |
|   |   |  Enterococcus faecalis | 100%  |
|   |   |  Enterococcus faecium | 100%  |
|   |   |  Negative blood matrix | 0%  |
|  γ -Globulin | 6 g/dL | Staphylococcus aureus | 100%  |
|   |   |  Staphylococcus epidermidis | 100%  |
|   |   |  Streptococcus pneumoniae | 100%  |
|   |   |  Streptococcus agalactiae | 100%  |
|   |   |  Enterococcus faecalis | 100%  |

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|   |  | Enterococcus faecalis | 100%  |
| --- | --- | --- | --- |
|   |   |  Enterococcus faecium | 100%  |
|   |   |  Negative blood matrix | 0%  |
|  Sodium polyanethol-sulfonate | 0.25% w/v | Staphylococcus aureus | 100%  |
|   |   |  Staphylococcus epidermidis | 100%  |
|   |   |  Streptococcus pneumoniae | 100%  |
|   |   |  Streptococcus agalactiae | 100%  |
|   |   |  Enterococcus faecalis | 100%  |
|   |   |  Enterococcus faecium | 100%  |
|   |   |  Negative blood matrix | 0%  |
|  No Interferent | Staphylococcus aureus | 100%  |   |
|   |   |  Staphylococcus epidermidis | 100%  |
|   |   |  Streptococcus pneumoniae | 100%  |
|   |   |  Streptococcus agalactiae | 100%  |
|   |   |  Enterococcus faecalis | 100%  |
|   |   |  Enterococcus faecium | 100%  |
|   |   |  Negative blood matrix | 0%  |

# 4. Assay Reportable Range:

Not applicable as the test device is a qualitative assay.

# 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Sample Stability: A specimen stability study was conducted to establish the recommended storage conditions for positive blood cultures before testing with the LIAISON PLEX Gram-Positive Blood Culture (BCP) Assay. A representative panel of six organisms including aerobic/anaerobic gram-positive pathogens and resistance markers, as well as a negative blood matrix control were tested. Fresh samples containing ring positive, and ring positive +8 hours concentrations of organisms were stored at 2°C and 30°C and tested at T0, after 26 hours (T1), 74 hours (T2) and 8 days (T3). Results of the sample stability study are summarized in Table 14 and Table 15, below.

Table 14. Sample Stability Study Results - 2°C

|  Analyte | Condition | Percent Positivity per Tested Timepoint  |   |   |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  T0 | T1 | T2 | T3  |
|  Enterococcus faecalis | Ring Positive | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  vanB1 | Ring Positive +8 | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Enterococcus faecalis | Ring Positive | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  vanB1 | Ring Positive +8 | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Listeria monocytogenes | Ring Positive | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|   |  Ring Positive +8 | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus spp. | Ring Positive | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus aureus |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  mecA/mecC |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus spp. | Ring Positive +8 | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus aureus |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  mecA/mecC |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus spp. | Ring Positive | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus epidermidis |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  mecA/mecC |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus spp. | Ring Positive +8 | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |

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Table 15. Sample Stability Study Results -  ${30}^{ \circ  }\mathrm{C}$  .

|  Analyte | Condition | Percent Positivity per Tested Timepoint  |   |   |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  T0 | T1 | T2 | T3  |
|  Enterococcus faecalis | Ring Positive | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  vanB1 | Ring Positive +8 | 100% (20/20)1 | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Enterococcus faecalis | Ring Positive | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  vanB1 | Ring Positive +8 | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Listeria monocytogenes | Ring Positive | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|   |  Ring Positive +8 | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus spp. | Ring Positive | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus aureus |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  mecA/mecC |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus spp. | Ring Positive +8 | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus aureus |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  mecA/mecC |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100%  |
|  Staphylococcus spp. | Ring Positive | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus eidermidis |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  mecA/mecC | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10) | 100%  |
|  Staphylococcus spp. | Ring Positive +8 | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus eidermidis |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100%  |

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|  Streptococcus spp. | Ring Positive +8 | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
| --- | --- | --- | --- | --- | --- |
|  Streptococcus pyogenes |   | 100% (20/20) | 100% (10/10) | 100% (10/10) | 100% (10/10)  |
|  Negative Blood Matrix | NA | 0% (0/4) | 0% (0/3) | 0% (0/3) | 0% (0/3)  |

Two bottles were grown and tested to assess vanB sample stability. Bottle 1 resulted in  $< 100\%$  positivity at T(0), 26 hours, and 74 hours at bottle/ring positive. Bottle 2 was grown and resulted in  $100\%$  positivity at all timepoints tested.

Fresh vs. Frozen Study: To support the use of frozen samples in the clinical study, the performance of the LIAISON PLEX BCP Assay with fresh and frozen samples was evaluated by testing five on-panel organisms (at both ring positive and ring positive + 8 hours organism concentrations) as well as a negative blood matrix control. Specifically, seven conditions were evaluated: Initial testing of fresh samples (T0), 1 freeze-thaw cycle (T1), 2 freeze-thaw cycles (T2), 3 freeze-thaw cycles (T3), 1 freeze-thaw cycle after over 8 hours of frozen storage (T4), 15 days (T5), and 1 month of frozen storage (T6). Samples were stored frozen  $(-80^{\circ})$  for a minimum of 8 hours in between each freeze-thaw cycle and allowed to equilibrate at RT before testing. Results presented in Table 16, demonstrated  $100\%$  positivity for target positive samples for all testing conditions and  $0\%$  positivity for negative blood culture sample.

Table 16. Fresh Vs. Frozen Study Results

|  Analyte | Condition | Percent Positivity per Tested Timepoint  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  T0 Fresh | T1 1stF/T | T2 2ndF/T | T3 3rdF/T | T4 (≥8 hours) | T5 (15 days) | T6 (30 days)  |
|  Enterococcus faecalis | Ring Positive | 100% (3/3) | 100% (12/12) | 100% (10/10) | 100% (10/10) | 100% (12/12) | 100% (10/10) | 100% (10/10)  |
|   |  Ring Positive +8 | 100% (3/3) | 100% (12/12) | 100% (10/10) | 100% (10/10) | 100% (12/12) | 100% (10/10) | 100% (10/10)  |
|  Listeria monocytogenes | Ring Positive | 100% (3/3) | 100% (12/12) | 100% (10/10) | 100% (10/10) | 100% (12/12) | 100% (10/10) | 100% (10/10)  |
|   |  Ring Positive +8 | 100% (3/3) | 100% (12/12) | 100% (10/10) | 100% (10/10) | 100% (12/12) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus aureus | Ring Positive | 100% (3/3) | 100% (12/12) | 100% (10/10) | 100% (10/10) | 100% (12/12) | 100% (10/10) | 100% (10/10)  |
|   |  Ring Positive +8 | 100% (3/3) | 100% (12/12) | 100% (10/10) | 100% (10/10) | 100% (12/12) | 100% (10/10) | 100% (10/10)  |
|  Staphylococcus epidermidis | Ring Positive | 100% (3/3) | 100% (12/12) | 100% (10/10) | 100% (10/10) | 100% (12/12) | 100% (10/10) | 100% (10/10)  |
|   |  Ring Positive +8 | 100% (3/3) | 100% (12/12) | 100% (10/10) | 100% (10/10) | 100% (12/12) | 100% (10/10) | 100% (10/10)  |
|  Streptococcus pyogenes | Ring Positive | 100% (3/3) | 100% (12/12) | 100% (10/10) | 100% (10/10) | 100% (12/12) | 100% (10/10) | 100% (10/10)  |
|   |  Ring Positive +8 | 100% (3/3) | 100% (12/12) | 100% (10/10) | 100% (10/10) | 100% (12/12) | 100% (10/10) | 100% (10/10)  |
|  Negative Blood Matrix | NA | 0% (0/3) | 0% (0/3) | 0% (0/3) | 0% (0/3) | 0% (0/3) | 0% (0/3) | 0% (0/3)  |

# 6. Detection Limit:

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Growth and Detection Study: A growth and detection study was performed to establish the range of expected organism concentrations present in incubated blood culture bottles at ring positive and at 8 hours after ring positive conditions. Eleven representative organisms of the LIAISON PLEX BCP Assay reportable targets were incubated and monitored to ring positive and eight hours after ringing positive using a continuous monitoring blood culture system. Three bottles for each organism were grown and three replicates were tested for each bottle, for a total of 9 replicates tested per organism. Additionally, bacterial CFU/mL were quantified for each bottle. Results are summarized in Table 17, below.

Table 17. Growth and Detection Study Results

|  Organism Tested | Expected Target | Ring Positive |   | Ring Positive +8 hours  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  CFU/mL Per Bottle | Positive Agreement/Total (% Detected) | CFU/mL Per Bottle | Positive Agreement/Total (% Detected)  |
|  Bacillus subtilis | Bacillus spp. | 1.29E+08 | 9/9 (100%) | 3.57E+05 | 9/9 (100%)  |
|   |   |  6.10E+08 |   | 4.97E+05  |   |
|   |   |  3.60E+08 |   | 2.90E+05  |   |
|  Enterococcus faecium | Enterococcus faecium / vanA | 2.37E+08 | 9/9 (100%) | 9.30E+08 | 9/9 (100%)  |
|   |   |  3.01E+08 |   | 7.80E+08  |   |
|   |   |  2.24E+08 |   | 9.30E+08  |   |
|  Enterococcus faecalis | Enterococcus faecalis/ vanB | 6.87E+08 | 9/9 (100%) | 2.90E+09 | 9/9 (100%)  |
|   |   |  9.27E+08 |   | 2.80E+09  |   |
|   |   |  9.83E+08 |   | 2.57E+09  |   |
|  Listeria monocytogenes | Listeria spp. | 7.57E+08 | 9/9 (100%) | 6.40E+08 | 9/9 (100%)  |
|   |   |  9.63E+08 |   | 4.33E+08  |   |
|   |   |  7.73E+08 |   | 8.17E+08  |   |
|  Staphylococcus aureus | Staphylococcus spp. Staphylococcus aureus mecA/mecC | 1.52E+07 | 9/9 (100%) | 3.80E+08 | 9/9 (100%)  |
|   |   |  2.34E+07 |   | 4.10E+08  |   |
|   |   |  1.88E+07 |   | 1.30E+08  |   |
|  Staphylococcus epidermidis | Staphylococcus spp. Staphylococcus epidermidis mecA/mecC | 1.55E+08 | 9/9 (100%) | 1.40E+09 | 9/9 (100%)  |
|   |   |  4.40E+08 |   | 1.48E+09  |   |
|   |   |  2.84E+08 |   | 1.52E+09  |   |
|  Staphylococcus lugdunensis | Staphylococcus spp. Staphylococcus lugdunensis mecA/mecC | 5.67E+08 | 9/9 (100%) | 2.83E+08 | 9/9 (100%)  |
|   |   |  7.43E+08 |   | 2.92E+08  |   |
|   |   |  8.90E+08 |   | 2.65E+08  |   |
|  Streptococcus agalactiae | Streptococcus spp. Streptococcus agalactiae | 1.21E+09 | 9/9 (100%) | 1.69E+09 | 9/9 (100%)  |
|   |   |  1.32E+09 |   | 1.48E+09  |   |
|   |   |  1.12E+09 |   | 2.03E+09  |   |
|  Streptococcus anginosus | Streptococcus spp. Streptococcus anginosus group | 7.57E+08 | 9/9 (100%) | 3.30E+06 | 9/9 (100%)  |
|   |   |  4.97E+08 |   | 6.13E+06  |   |
|   |   |  3.63E+08 |   | 1.90E+07  |   |
|  Streptococcus pneumoniae | Streptococcus spp. Streptococcus pneumoniae | 8.30E+08 | 9/9 (100%) | 1.35E+07 | 9/9 (100%)  |
|   |   |  8.40E+08 |   | 1.92E+07  |   |
|   |   |  9.80E+08 |   | 1.54E+08  |   |
|  Streptococcus pyogenes | Streptococcus spp. Streptococcus pyogenes | 3.43E+08 | 9/9 (100%) | 7.60E+08 | 9/9 (100%)  |
|   |   |  3.40E+08 |   | 5.00E+08  |   |
|   |   |  4.70E+08 |   | 4.10E+08  |   |
|   |   | Ring Negative  |   |   |   |
|  Negative Blood | None | 0/3 (0%)  |   |   |   |

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7. Assay Cut-Off:

The specific parameters for the LIAISON PLEX BCP Assay are considered confidential and proprietary

8. Accuracy (Instrument):

Not applicable.

9. Carry-Over:

Carry Over and Cross Contamination: A study was conducted to evaluate the risk of carry-over and cross contamination occurring during normal use of the device when highly concentrated positive specimens are processed alongside negative specimens. Two operators tested 30 positive samples containing Staphylococcus aureus at concentrations of 1.90E+08 CFU/mL and 30 negative samples consisting of negative blood matrix. S. aureus was selected since its detection implies positivity of three analyte targets of the assay (i.e., Staphylococcus spp., S. aureus, and mecA/C). Testing was conducted with two LIAISON PLEX instruments containing six modules. Each operator was assigned to a single instrument throughout the four days of testing. The samples were loaded into cartridges alternating between positive and negative samples (in a checkerboard fashion), six specimens at a time using sample prep trays. The six cartridges were loaded into a LIAISON PLEX instrument in the same order they were loaded with sample. The order of positive and negative specimens was alternated across the ten runs of six cartridges to ensure that each blade of the instrument alternatively processed high positive and negative specimens. Results of the Carry-Over study are summarized in Table 18.

Table 18. Carry-Over/Cross Contamination Results

|   | Positive Control |   |   | Negative Control  |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Staphylococcus spp. | S. aureus | mecA/C | Staphylococcus spp. | S. aureus | mecA/C  |
|  Run 1, Operator 1 | 100% | 100% | 100% | 0% | 0% | 0%  |
|  Run 2, Operator 1 | 100% | 100% | 100% | 0% | 0% | 0%  |
|  Run 3, Operator 1 | 100% | 100% | 100% | 0% | 0% | 0%  |
|  Run 4, Operator 1 | 100% | 100% | 100% | 0% | 0% | 0%  |
|  Run 5, Operator 1 | 100% | 100% | 100% | 0% | 0% | 0%  |
|  Run 1, Operator 2 | 100% | 100% | 100% | 0% | 0% | 0%  |
|  Run 2, Operator 2 | 100% | 100% | 100% | 0% | 0% | 0%  |
|  Run 3, Operator 2 | 100% | 100% | 100% | 0% | 0% | 0%  |
|  Run 4, Operator 2 | 100% | 100% | 100% | 0% | 0% | 0%  |
|  Run 5, Operator 2 | 100% | 100% | 100% | 0% | 0% | 0%  |

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# B Comparison Studies:

1. Method Comparison with Predicate Device:

Please refer to the Clinical Studies Section below.

2. Bottle Type Equivalency Study: An equivalency study was conducted to demonstrate similar performance of the LIAISON PLEX BCP Assay among 12 different blood culture bottle types from three different blood culture systems (BacT/Alert, BACTEC, and VersaTREK). A minimum of two lots per media bottle type were used to grow blood culture samples containing representative on-panel BCP targets with resistance markers, off-panel (gram-negative) targets, and negative blood matrix (NBM). The organisms evaluated and the average titers of each organism grown in the 12 different types of media bottles are shown in Table 19. A total of 596 independent blood culture bottles were evaluated, which included 464 gram-positive blood cultures, 120 gram-negative blood cultures, and 12 negative blood matrix bottles (Table 20). The bioMerieux BACT/ALERT FA Plus blood culture bottle type (PN: 410851) was not tested in this study as the effectiveness of this bottle type is established through blood culture growth required for all other analytical studies, such as growth and detection and analytical reactivity/inclusivity verification testing.

Table 19. Organisms Evaluated in Bottle Type Equivalency Study

| Tested Organism | Strain ID | Target Analyte | Bottle Concentration (CFU/mL) |
| --- | --- | --- | --- |
| Bacillus cereus | ATCC10702 | Bacillus spp. | 6.10E+07b - 4.40E+08 |
| Bacillus subtilis | ATCC 19659 | Bacillus spp. | 4.90E+05 - 3.73E+08 |
| Enterococcus faecalis | ATCC 51575 | Enterococcus faecalis | vanB | 8.63E+07 - 3.50E+09a |
| Enterococcus faecalis | Clinical Isolate CLCS VRE-1 | Enterococcus faecalis | vanA | 9.20E+06 - 6.50E+08 |
| Enterococcus faecium | ATCC 700221 | Enterococcus faecium | vanA | 3.17E+07 - 9.77E+08 |
| Enterococcus faecium | ATCC 51858 | Enterococcus faecium | vanB | 3.83E+06 - 5.50E+08 |
| Listeria ivanovii | ATCC 700402 | Listeria spp. | 1.50E+08 - 1.40E+09 |
| Listeria monocytogenes | ATCC 15313 | Listeria spp. | 6.60E+07 - 1.88E+09 |
| Staphylococcus aureus | ATCC BAA-2312 | Staphylococcus spp. | S. aureus | mecA/C | 8.00E+06 - 1.29E+09 |
| Staphylococcus aureus | CDC AR-0227 | Staphylococcus spp. | S. aureus | mecA/C | 1.43E+07 - 3.50E+09 |
| Staphylococcus epidermidis | ATCC 35984 | Staphylococcus spp. | S. epidermidis | mecA/C | 6.93E+06 - 1.43E+09 |
| Staphylococcus lugdunensis | ATCC 49576 | Staphylococcus spp. | S. lugdunensis | 2.20E+07 - 3.46E+09 |
| Streptococcus agalactiae | ATCC 12386 | Streptococcus spp. | S. agalactiae | 2.70E+07 - 1.71E+09 |
| Streptococcus anginosus | ATCC 33397 | Streptococcus spp. | S. anginosus Group | 1.82E+07 - 4.37E+09 |
| Streptococcus constellatus | ATCC 27823 | Streptococcus spp. | S. anginosus Group | 4.00E+07 - 2.53E+09 |

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Table 20. Blood Culture Bottle Type Equivalency Study Results

|  Blood Culture Bottle Manufacturer (System) | Blood Culture Bottle Type^{a} | Number of Inoculated Bottles |   | Negative Blood Matrix^{d}  |
| --- | --- | --- | --- | --- |
|  Biomerieux BACT/ALERT 3D System | BACT/ALERT SA (Standard Aerobic) | 20/20 | 10/10 | 1/1  |
|   |  BACT/ALERT SN (Standard Anaerobic) | 20/20 | 10/10 | 1/1  |
|   |  BACT/ALERT FN Plus (Anaerobic) | 20/20 | 10/10 | 1/1  |
|   |  BACT/ALERT PF Plus (Pediatric) | 58/58 | 10/10 | 1/1  |
|  Becton Dickinson 9050 / FX40^{a} | BACTEC Standard (Aerobic) | 20/20^{b} | 10/10 | 1/1  |
|   |  BACTEC Plus (Aerobic) | 20/20 | 10/10 | 1/1  |
|   |  BACTEC Standard (Anaerobic) | 58/58 | 10/10 | 1/1  |
|   |  BACTEC Plus (Anaerobic) | 58/58 | 10/10 | 1/1  |
|   |  BACTEC Peds Plus (Pediatric) | 58/58 | 10/10 | 1/1  |
|  BACTEC Lytic (Lytic Anaerobic) | 20/20 | 10/10 | 1/1 |   |
|  Thermo Scientific a VersaTREK^{a} | REDOX 1 EZ Draw (Aerobic) | 56/56 | 10/10 | 1/1  |
|   |  REDOX 2 EZ Draw (Anaerobic) | 56/56 | 10/10 | 1/1  |
|  Bottles with Expected Results/Total Number Blood Bottles |   | 464/464^{b} | 120/120 | 12/12  |

a For gram-positive blood culture preparations, BACTEC and VersaTREK systems were not available and corresponding media bottles were placed in a standard laboratory incubator with a shaker for growth. For gram-positive blood culture growth, only VersaTREK bottles needed to be placed in a standard laboratory incubator with a shaker in lieu of VersaTREK system; BACT/ALERT and BACTEC blood bottles were grown using corresponding automated blood culture systems up to bottle ring positivity.
b One organism, (E. faecalis strain 51575) required use of an 8+ bottle to confirm the bottle matrix was not inhibitory.

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${}^{c}$  Biomerieux BACT/ALERT FA Plus blood culture bottle type (PN: 410851) was not tested in this study protocol as the effectiveness of this bottle type is established through blood culture growth required for other analytical studies including growth and detection and analytical reactivity/ inclusivity verification.
Each unique bottle of Negative Blood Matrix was tested in replicates of three.

# C Clinical Studies:

To establish the clinical performance of the LIAISON Plex BCP Assay, a total of 1045 samples were tested. Among these, 509 were samples prospectively collected (Arm 1) from four geographically different sites in the U.S., 162 were pre-selected, left over samples (Arm 2) that were blinded, randomized, and tested along with unique negative clinical specimens at four BCP testing sites. Table 21 below shows a summary of the demographic information for the 509 prospectively collected and 162 pre-selected specimens that were included in the study. A total of 255 contrived samples (Arm 3) were also evaluated for low prevalence analytes where an insufficient number of positive samples were obtained from prospective or retrospective samples. Contrived samples were prepared by inoculating isolated colonies of the specific Gram-Positive organisms in blood culture bottles containing whole blood from unique donors. A summary of the organisms used to prepare contrived samples is provided in Table 22, below. Contrived samples were blinded, randomized, and tested along with negative clinical specimens at four testing sites.

Sensitivity and specificity of the device was established by comparing the results of the LIAISON Plex Blood Culture Gram Positive Assay to culture followed by automated microbiological/biochemical identification using VITEK 2 instrument system for 13 analytes (i.e., Enterococcus faecalis, Enterococcus faecium, Listeria spp., Staphylococcus spp., S. aureus, S. epidermidis, S. ludguneneis, Streptococcus spp., S. agalactiae, S. anginosus group, S. pneumoniae, and S. pyogenes) and from PCR and bi-directional sequencing for 5 analytes (i.e., Bacillus spp., meA/mecC, vanA, vanB). The performance of the device and  $95\%$  CI were calculated for each arm of the study, as shown in Table 23, below. The LIAISON PLEX BCP Assay reports genus level for Bacillus spp., Staphylococcus spp., and Streptococcus spp. Positive percent agreement (PPA) for target organisms in all studies stratified at the species level is presented in Table 24, below. Additionally, the LIAISON PLEX BCP Assay reports the presence or absence of resistance markers only if an associated organism is also detected. PPA for each resistance marker stratified by eligible organism is listed in Table 25.

Table 21. Demographic Information of Clinical Study Participants

|   | Prospective (N=509) | Pre-Selected (N=162)  |
| --- | --- | --- |
|   |  Specimens (%) | Specimens (%)  |
|  Gender All Sites  |   |   |
|  Male | 295 (58.0%) | 87 (53.7%)  |
|  Female | 214 (42.0%) | 71 (43.8%)  |
|  Gender Unknown | 0 (0.0%) | 4 (2.5%)  |
|  Total | 509 (100.0%) | 162 (100.0%)  |
|  Age (years)  |   |   |
|  0-1 | 15 (2.9%) | 4 (2.5%)  |
|  >1-5 | 0 (0.0%) | 1 (0.6%)  |
|  >5-21 | 11 (2.2%) | 5 (3.1%)  |
|  <21-65 | 266 (52.3%) | 83 (51.2%)  |
|  >65 | 213 (41.8%) | 57 (35.2%)  |

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Table 22. Organisms Evaluated with Contrived Samples

|  Organism | Resistance Marker (s) | Strain | # of Specimens Tested  |
| --- | --- | --- | --- |
|  Bacillus amyloliquefaciens | NA | ATCC 23350 | 10  |
|  Bacillus atrophaeus | NA | ATCC 6455 | 10  |
|  Bacillus cereus | NA | ATCC 11778 | 10  |
|  Bacillus licheniformis | NA | ATCC 14580 | 10  |
|  Bacillus thuringiensis | NA | ATCC 10792 | 10  |
|  Total Bacillus spp. |   |   | 50  |
|  Enterococcus faecalis | vanB | ATCC 700802 | 10  |
|   |   |  ATCC 51299 | 10  |
|   |   |  64188262 | 10  |
|  Total Enterococcus faecalis |   |   | 30  |
|  Enterococcus faecium | vanB | ATCC 51858 | 10  |
|   |   |  JMI CS-712 | 10  |
|  Total Enterococcus faecium |   |   | 20  |
|  Listeria grayi | NA | ATCC 25401 | 10  |
|  Listeria innocua | NA | ATCC 33090 | 10  |
|  Listeria ivanovii | NA | ATCC 19119 | 10  |
|  Listeria monocytogenes | NA | ATCC 19114 | 8  |
|  Listeria welshimeri | NA | ATCC 35897 | 11  |
|  Total Listeria spp. |   |   |   |
|  Staphylococcus lugdunensis | NA | ATCC 84497462 | 50  |

Table 23. Clinical Study Performance Summary

|  Analyte | Study | Sensitivity/PPA |   |   | Specificity/NPA  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  TP/ (TP+FN) | (%) | 95% CI (%) | TN/ (TN+FP) | (%) | 95% CI (%)  |
|  Bacillus spp. | Prospective | 1/1 | 100 | 20.7 – 100 | 506/507 | 99.8 | 98.9 – 100  |
|  Bacillus cereus | NA | 1/1 | 100 | 10.0 – 100 | 506/507 | 99.8 | 98.9 – 100  |
|  Bacillus licheniformis | NA | 1/1 | 100 | 10.0 – 100 | 506/507 | 99.8 | 98.9 – 100  |
|  Bacillus thuringiensis | NA | 1/1 | 100 | 10.0 – 100 | 506/507 | 99.8 | 98.9 – 100  |

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|  Enterococcus faecalis | Archived | 17/19 | 89.5 | 68.6 – 97.1 | 173/174 | 99.4 | 96.8 – 99.9  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Combined | 18/20 | 90.0 | 69.9 – 97.2 | 679/681^{1} | 99.7 | 98.9 – 99.9  |
|   | Contrived | 50/50 | 100 | 92.9 - 100 | 268/268 | 100 | 98.6 - 100  |
|   | Prospective | 38/38 | 100 | 90.8 - 100 | 468/468 | 100 | 99.2 - 100  |
|   | Archived | 2/2 | 100 | 34.2 - 100 | 147/147 | 100 | 97.5 – 100  |
|   | Combined | 40/40 | 100 | 91.2 - 100 | 615/615 | 100 | 99.4 - 100  |
|   | Contrived | 30/30 | 100 | 88.6 - 100 | 288/288 | 100 | 98.7 - 100  |
|   | Prospective | 16/16 | 100 | 80.6 - 100 | 489/489 | 99.8 | 98.9 – 100  |
|   | Archived | 20/20 | 100 | 83.9 - 100 | 128/129 | 99.2 | 95.7 – 99.9  |
|   | Combined | 36/36 | 100 | 90.4 - 100 | 617/619^{2} | 99.7 | 98.8 – 99.9  |
|   | Contrived | 20/20 | 100 | 83.9 - 100 | 298/298 | 100 | 98.7 - 100  |
|   | Prospective | 0/0 | NA | NA | 506/506 | 100 | 99.2 – 100  |
|   | Archived | 5/5 | 100 | 56.6 - 100 | 144/144 | 100 | 97.4 – 100  |
|   | Combined | 5/5 | 100 | 56.6 - 100 | 650/650 | 100 | 99.4 - 100  |
|   | Contrived | 49/49 | 100 | 92.7 - 100 | 269/269 | 100 | 98.6 - 100  |
|   | Prospective | 316/322 | 98.1 | 96 – 99.1 | 182/184 | 98.9 | 96.1 – 99.7  |
|   | Archived | 20/20 | 100 | 83.9 - 100 | 129/129 | 100 | 97.1 – 100  |
|   | Combined | 336/342^{3} | 98.2 | 96.2 – 99.2 | 311/313^{4} | 99.4 | 97.7 – 99.8  |
|   | Contrived | 50/50 | 100 | 92.9 - 100 | 268/268 | 100 | 98.6 - 100  |
|   | Prospective | 160/161 | 99.4 | 96.6 – 99.9 | 344/345 | 99.7 | 98.4 – 99.9  |
|   | Archived | 0/0 | NA | NA | 149/149 | 100 | 97.5 – 100  |
|   | Combined | 160/161 | 99.4 | 96.6 – 99.9 | 493/494^{5} | 99.8 | 98.9 - 100  |
|   | Contrived | 0/0 | NA | NA | 318/318 | 100 | 98.8 - 100  |
|   | Prospective | 93/96^{7} | 96.9 | 91.2 – 98.9 | 405/410 | 98.8 | 97.2 – 99.5  |
|   | Archived | 0/0 | NA | NA | 148/149 | 99.3 | 96.3 – 99.9  |
|   | Combined | 93/96^{6} | 96.9 | 91.2 – 98.9 | 553/559^{7} | 98.9 | 97.7 – 99.5  |
|   | Contrived | 0/0 | NA | NA | 318/318 | 100 | 98.8 - 100  |
|   | Prospective | 6/6 | 100 | 61 – 100 | 500/500 | 100 | 99.2 - 100  |
|   | Archived | 20/20 | 100 | 83.9 - 100 | 129/129 | 100 | 97.1 – 100  |
|   | Combined | 26/26 | 100 | 87.1 -100 | 629/629 | 100 | 99.4 - 100  |
|   | Contrived | 50/50 | 100 | 92.9 - 100 | 267/268 | 99.6 | 97.9 - 99.9  |
|   | Prospective | 97/98 | 99 | 94.4 - 99.8 | 406/408 | 99.5 | 98.2 - 99.9  |
|   | Archived | 78/80 | 97.5 | 91.3 - 99.3 | 69/69 | 100 | 94.7 - 100  |
|   | Combined | 175/178 | 98.3 | 95.2 - 99.4 | 475/477^{8} | 99.6 | 98.5 - 99.9  |
|   | Contrived | 0/0 | NA | NA | 317/318 | 99.7 | 98.2 - 99.9  |
|   | Prospective | 21/21 | 100 | 84.5 - 100 | 485/485 | 100 | 99.2 - 100  |
|   | Archived | 17/17 | 100 | 81.6 - 100 | 132/132 | 100 | 97.2 - 100  |
|   | Combined | 38/38 | 100 | 90.8 - 100 | 617/617 | 100 | 99.4 - 100  |
|   | Contrived | 0/0 | NA | NA | 318/318 | 100 | 98.8 - 100  |
|   | Prospective | 8/9 | 88.9 | 56.5 - 98 | 496/497 | 99.8 | 98.9 - 100  |
|   | Archived | 25/26 | 96.2 | 81.1 - 99.3 | 123/123 | 100 | 97 - 100  |
|   | Combined | 33/35 | 94.3 | 81.4 - 98.4 | 619/620^{9} | 99.8 | 99.1 - 100  |
|   | Contrived | 0/0 | NA | NA | 318/318 | 100 | 98.8 - 100  |
|   | Prospective | 11/11 | 100 | 74.1 - 100 | 494/495 | 99.8 | 98.9 - 100  |
|   | Archived | 21/21 | 100 | 84.5 - 100 | 128/128 | 100 | 97.1 - 100  |
|   | Combined | 32/32 | 100 | 89.3 - 100 | 622/623 | 99.8 | 99.1 - 100  |
|   | Contrived | 0/0 | NA | NA | 318/318 | 100 | 98.8 - 100  |
|   | Prospective | 21/21 | 100 | 84.5 - 100 | 485/485 | 100 | 99.2 - 100  |
|   | Archived | 16/16 | 100 | 80.6 - 100 | 133/133 | 100 | 97.2 - 100  |
|   | Combined | 37/37 | 100 | 90.6 - 100 | 618/618 | 100 | 99.4 - 100  |
|   | Contrived | 0/0 | NA | NA | 318/318 | 100 | 98.8 - 100  |
|  Resistance Markers^{10}  |   |   |   |   |   |   |   |
|  mecA/mecC | Prospective…

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PAM/K243490](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PAM/K243490)

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