LIAISON PLEX Yeast Blood Culture Assay

K240627 · Luminex Corporation · PEO · Jun 4, 2024 · Microbiology

Device Facts

• Record ID: K240627
• Device Name: LIAISON PLEX Yeast Blood Culture Assay
• Applicant: Luminex Corporation
• Product Code: PEO · Microbiology
• Decision Date: Jun 4, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3365
• Device Class: Class 2

Intended Use

The LIAISON PLEX® Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the LIAISON PLEX® System for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The LIAISON PLEX® BCY Assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain fungal organisms as determined by Gram Stain. The LIAISON PLEX® BCY Assay detects and identifies the following fungal organisms: Candida albicans, Candida auris, Candida dubliniensis, Candida famata, Candida glabrata, Candida guilliermondii, Candida kefyr, Candida krusei, Candida lipolytica, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Candida haemulonii/duobushaemulonii, Cryptococcus neoformans/gattii. The detection and identification of specific fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from LIAISON PLEX® BCY Assay are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by LIAISON PLEX® BCY Assay may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by LIAISON PLEX® BCY Assay, susceptibility testing and differentiation of mixed growth) and clinical presentation must be taken into consideration in the final diagnosis of bloodstream infection.

Device Story

Device performs automated, sample-to-answer, qualitative multiplex nucleic acid testing on positive blood culture samples. System includes instrument, single-use disposable test cartridge, and transfer pipette. Workflow: user loads sample into cartridge, scans barcodes, and inserts cartridge into processing module. System automates: (a) nucleic acid extraction via mechanical/chemical lysis and magnetic beads; (b) multiplex PCR amplification; (c) hybridization of amplicons to capture DNA on a microarray glass slide; (d) signal analysis using silver-enhanced gold-nanoparticle probes and light scatter measurement. Output: detected/not detected results for 14 fungal targets. Used in clinical laboratories by trained operators. Results aid diagnosis of bloodstream infections when interpreted with Gram stain and clinical data; not for sole diagnostic use.

Clinical Evidence

Clinical study evaluated 132 clinical specimens (prospective and pre-selected) and 829 contrived specimens across four US sites. Combined prospective/pre-selected analysis showed high sensitivity/PPA and specificity/NPA for all targets (e.g., C. albicans 100% PPA, 99.0% NPA; C. glabrata 100% PPA, 100% NPA). Overall success rate for valid results was 99.8% after retesting. Comparator was standard of care culture with MALDI-TOF MS identification.

Technological Characteristics

System: LIAISON PLEX. Method: Real-time PCR, microarray hybridization, silver-enhanced gold-nanoparticle detection. Materials: Single-use disposable cartridge, glass slide microarray. Connectivity: Standalone instrument. Software: Automated processing and analysis. Standards: ISO 14971, IEC 62366-1, ISO 62304, IEC 61010-1, IEC 60601-1-2.

Indications for Use

Indicated for individuals exhibiting signs/symptoms of bloodstream infection. Used for qualitative detection/identification of fungal organisms in positive blood culture samples containing fungal organisms (Gram stain positive).

Regulatory Classification

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

• GenMark ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) (K182690)

Submission Summary (Full Text)

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June 4, 2024

Image /page/0/Picture/1 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Luminex Corporation Sarah Herzog Sr. Regulatory Affairs Associate 4088 Commercial Avenue Northbrook, Illinois 60062

# Re: K240627

Trade/Device Name: LIAISON PLEX Yeast Blood Culture Assay Regulation Number: 21 CFR 866.3365 Regulation Name: Multiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures Regulatory Class: Class II Product Code: PEO, NSU Dated: March 5, 2024 Received: March 6, 2024

Dear Sarah Herzog:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

# Noel J. Gerald -S

Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K240627

Device Name LIAISON PLEX Yeast Blood Culture Assay

## Indications for Use (Describe)

The LIAISON PLEX Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the LIAISON PLEX System for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The LIAISON PLEX BCY Assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain fungal organisms as determined by Gram Stain. The LIAISON PLEX BCY Assay detects and identifies the following fungal organisms:

Candida albicans Candida auris Candida dubliniensis Candida famata Candida glabrata Candida guilliermondii Candida kefyr Candida krusei Candida lipolytica Candida lusitaniae Candida parapsilosis Candida tropicalis Candida haemulonii / duobushaemulonii Cryptococcus neoformans / gattii

The detection and identification of specific fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from LIAISON PLEX BCY Assay are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment management decisions.

Negative results in the setting of a suspected bloodstream infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by LIAISON PLEX BCY Assay may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by LIAISON PLEX BCY Assay, susceptibility testing and differentiation of mixed growth) and clinical presentation must be taken into consideration in the final diagnosis of bloodstream infection.

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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Image /page/4/Picture/0 description: The image shows the logo for Luminex. The word "Luminex" is written in a bold, black font, with a red dot above the "i". Below the logo is the tagline "complexity simplified.", with a red dot at the end.

#### 510(k) Summary

This Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Preparation date: 05 March 2024

#### A. 510(k) Number:

K240627

#### B. Purpose for Submission:

Traditional 510(k), New Device

#### C. Measurand:

Candida albicans, Candida auris, Candida dublinensis, Candida qlabrata, Candida guilliermondii, Candida kefyr, Candida krusei, Candida lipolytica, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Candida haemulonii/duobushaemulonii, and Cryptococcus neoformans/gatti

#### D. Type of Test:

Qualitative Real Time Polymerase Chain Reaction (PCR)

#### E. Applicant:

Sarah Herzog, Luminex Corporation 4088 Commercial Avenue Northbrook, IL 60062 [phone]

## F. Proprietary and Established Names:

LIAISON PLEX® Yeast Blood Culture Assay

#### G. Regulatory Information:

| Product<br>Code | Classification | Regulation Section | Panel |
|-----------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| PEO | II | 21 CFR 866.3365 – Multiplex Nucleic Acid<br>Assay for Identification of Microorganisms<br>and Resistance Markers from Positive<br>Blood Cultures | 83 (Microbiology) |

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Image /page/5/Picture/0 description: The image shows the Luminex logo. The word "Luminex" is written in a bold, sans-serif font, with the letters in black. There is a red dot above the "i" in Luminex. A small registered trademark symbol is located to the right of the "x".

complexity simplit

LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission

# H. Intended Use:

# 1. Intended use(s):

The LIAISON PLEX® Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the LIAISON PLEX® System for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The LIAISON PLEX® BCY Assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain fungal organisms as determined by Gram Stain.

The LIAISON PLEX® BCY Assay detects and identifies the following fungal organisms:

| Candida albicans |
|-------------------------------------|
| Candida auris |
| Candida dubliniensis |
| Candida famata |
| Candida glabrata |
| Candida guilliermondii |
| Candida kefyr |
| Candida krusei |
| Candida lipolytica |
| Candida lusitaniae |
| Candida parapsilosis |
| Candida tropicalis |
| Candida haemulonii/duobushaemulonii |
| Cryptococcus neoformans/gattii |

The detection and identification of specific fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from LIAISON PLEX® BCY Assay are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by LIAISON PLEX® BCY Assay may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by LIAISON PLEX® BCY Assay, susceptibility testing and differentiation of mixed growth) and clinical presentation must be taken into consideration in the final diagnosis of bloodstream infection.

- 2. Indication(s) for use:
Same as intended use.

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Image /page/6/Picture/0 description: The image shows the logo for Luminex. The word "Luminex" is written in a bold, sans-serif font. The letters are black, except for a red dot above the "i". A registered trademark symbol is next to the x.

- LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission 3. Special conditions for use statement(s):
For prescription use only.

For in vitro diagnostic use only.

- 4. Special instrument requirements:
For use with LIAISON PLEX ® Systems.

#### l. Device Description:

The LIAISON PLEX "Yeast Blood Culture Assay (BCY 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 a fungal organism, as determined by a Gram stain. The system consists of an instrument, a single-use disposable test cartridge, and a transfer pipette. The user loads the sample into the sample port of the LIAISON PLEX Yeast 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 BCY 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; b) Amplification: Multiplex PCR based amplification of the extracted nucleic acid to generate target specific amplicons; c) Hybridization: Amplified DNA hybridizes to specific capture DNA arrayed on a glass slide in a microarray format and the bound target DNA, in turn, hybridizes with mediator and gold-nanoparticle probes; d) 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.

#### Substantial Equivalence Information: J.

- 1. Predicate device name(s): GenMark ePlex Blood Culture Identification Fungal Pathogen (BCID-FP)
- 2. Predicate 510(k) number(s): K182690
- 3. Comparison with predicate:

The following tables compare Luminex's LIAISON® Yeast Blood Culture Assay to the ePlex Blood Culture Identification Fungal Pathogen (BCID-FP).

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Image /page/7/Picture/0 description: The image shows the logo for Luminex. The logo is black text with a red dot above the i. The text is bold and slightly slanted.

# LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission

# Comparison to Predicate

| | Predicate Device: | Candidate Device: |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison<br>to Predicate<br>Device | GenMark ePlex Blood Culture Identification<br>Fungal Pathogen (BCID-FP), K182690 | LIAISON PLEX® Yeast Blood Culture Assay |
| Product Code | PEO | PEO |
| Regulation Number | 21 CFR 866.3365 | 21 CFR 866.3365 |
| Organism Detected | Candida albicans, Candida auris, Candida<br>dubliniensis, Candida famata, Candida<br>glabrata, Candida guilliermondii, Candida<br>kefyr, Candida krusei, Candida lusitaniae,<br>Candida parapsilosis, Candida tropicalis,<br>Cryptococcus gattii, Cryptococcus<br>neoformans, Fusarium, Rhodotorula | Candida albicans, Candida auris, Candida<br>dublinensis,<br>Candida famata, Candida glabrata,<br>Candida guilliermondii, Candida kefyr,<br>Candida krusei, Candida lipolytica,<br>Candida lusitaniae, Candida parapsilosis,<br>Candida tropicalis, Candida haemulonii/<br>duobushaemulonii, Cryptococcus<br>neoformans/gatti |
| Measurand | Nucleic acid from Organisms detected | Nucleic acid from Organisms detected |
| Intended Use | The GenMark ePlex Blood Culture<br>Identification Fungal Pathogen (BCID-FP)<br>Panel is a qualitative nucleic acid multiplex<br>in vitro diagnostic test intended for use on<br>GenMark's ePlex Instrument for<br>simultaneous detection and identification of<br>multiple potentially pathogenic fungal<br>organisms in positive blood culture. The<br>ePlex BCID-FP Panel is performed directly on<br>blood culture samples identified as positive<br>by a continuous monitoring blood culture<br>system and which contains fungal<br>organisms.<br>The following fungal organisms are identified<br>using the ePlex BCID-FP Panel: | The LIAISON PLEX Yeast Blood Culture<br>(BCY) Assay is a qualitative nucleic acid<br>multiplex in vitro diagnostic test intended<br>for use on the LIAISON PLEX System for<br>simultaneous detection and identification<br>of multiple potentially pathogenic fungal<br>organisms in positive blood culture. The<br>LIAISON PLEX BCY Assay is performed<br>directly on blood culture samples<br>identified as positive by a continuous<br>monitoring blood culture system and<br>which contain fungal organisms as<br>determined by Gram Stain.<br>The LIAISON PLEX BCY Assay detects and<br>identifies the following fungal organisms: |
| | Candida albicans Candida auris Candida dubliniensis Candida famata Candida glabrata Candida guilliermondii Candida kefyr Candida krusei Candida lusitaniae Candida parapsilosis Candida tropicalis Cryptococcus gattii Cryptococcus neoformans Fusarium Rhodotorula | Candida albicans Candida auris Candida dublinensis Candida famata Candida glabrata Candida guilliermondii Candida kefyr Candida krusei Candida lipolytica Candida lusitaniae Candida parapsilosis Candida tropicalis Candida haemulonii/<br>duobushaemulonii Cryptococcus neoformans/gatti |
| | The detection and identification of specific<br>fungal nucleic acids from individuals<br>exhibiting signs and/or symptoms of<br>bloodstream infection aids in the diagnosis<br>of bloodstream infection when used in<br>conjunction with other clinical information.<br>The results from the ePlex BCID-FP Panel<br>are intended to be interpreted in<br>conjunction with Gram stain results and<br>should not be used as the sole basis for<br>diagnosis, treatment, or other patient<br>management decisions.<br>Negative results in the setting of a<br>suspected bloodstream infection may be<br>due to infection with pathogens that are not<br>detected by this test. Positive results do not<br>rule out co-infection with other organisms;<br>the organism(s) detected by the ePlex BCID-<br>FP Panel may not be the definite cause of<br>disease. Additional laboratory testing (e.g.<br>sub-culturing of positive blood cultures for<br>identification of organisms not detected by<br>ePlex BCID-FP Panel, susceptibility testing<br>and differentiation of mixed growth) and<br>clinical presentation must be taken into<br>consideration in the final diagnosis of<br>bloodstream infection. | The detection and identification of<br>specific fungal nucleic acids from<br>individuals exhibiting signs and/or<br>symptoms of bloodstream infection aids<br>in the diagnostic of bloodstream<br>infection when used in conjunction with<br>other clinical information. The results<br>from the LIAISON PLEX BCY Assay are<br>intended to be interpreted in<br>conjunction with Gram stain results and<br>should not be used as the sole basis for<br>diagnosis, treatment, or other patient<br>management decisions.<br>Negative results in the setting of a<br>suspected bloodstream infection may be<br>due to infection with pathogens that are<br>not detected by this test. Positive results<br>do not rule out co-infection with other<br>organisms; the organism(s) detected by<br>LIAISON PLEX BCY Assay may not be the<br>definite cause of disease. Additional<br>laboratory testing (e.g. sub-culturing of<br>positive blood cultures for identification<br>of organisms not detected by LIAISON<br>PLEX BCY Assay, susceptibility testing<br>and differentiation of mixed growth) and<br>clinical presentation must be taken into<br>consideration in the final diagnosis of<br>bloodstream infection. |
| Automated System<br>(Sample to Answer) | Automated | Same |
| Instrumentation | ePlex Instrument | LIAISON PLEX® |
| Sample Types | Blood Culture | Same |

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Image /page/8/Picture/0 description: The image shows the logo for Luminex. The logo is black, with a red dot above the "i" in Luminex. The logo is simple and modern, and it is likely used on the company's website and marketing materials. The logo also has a registered trademark symbol on the bottom right.

LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission

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Image /page/9/Picture/0 description: The image shows the logo for Luminex. The word "Luminex" is written in a bold, sans-serif font, with the letters in black. There is a red dot above the "i" in Luminex. A registered trademark symbol is to the right of the "x".

LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission

# K. Standards/Guidance Documents Referenced:

- . Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures (May 2015)
- . Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff (October 2, 2023).
- . Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff (June 14, 2023).
- . Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff (September 27, 2023).
- . Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff (March 13, 2007).
- . CLSI. User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition. CLSI document EP12-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
- CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.
- . CLSI. Interference Testing in Clinical Chemistry. 3rd ed. CLSI guideline EP07. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.
- ISO 14971:2019 Medical devices - Application of risk management to medical devices
- . IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
- . ISO 62304:2006 Medical device software - Software life-cycle processes
- . ISO 15223-1:2016: Medical Devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
- . IEC 61010-1 Ed. 3.0 2010: 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

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Image /page/10/Picture/0 description: The image shows the Luminex logo. The word "Luminex" is written in a bold, sans-serif font, with the "i" dotted with a red circle. The logo has a registered trademark symbol to the right of the word.

LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission

- . 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

# L. Test Principle:

The LIAISON PLEX® Yeast Blood Culture Assay (BCY 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 a fungal organism, as determined by a Gram stain. The system consists of an instrument and a single-use, disposable test cartridge and a transfer pipette. The user loads the sample into the sample port of the LIAISON PLEX® Yeast 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 LIAISON PLEX® BCY 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; b) Amplification: Multiplex PCR based amplification of the extracted nucleic acid to generate target specific amplicons; c) Hybridization: Amplified DNA hybridizes to specific capture DNA arrayed on a glass slide in a microarray format and the bound target DNA, in turn, hybridizes with mediator and goldnanoparticle probes; d) 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.

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# M. Performance Characteristics:

#### 1. Analytical performance:

## a. Analytical Sensitivity (Limit of Detection)

A limit of detection study (LoD) was performed to evaluate the analytical sensitivity of the LIAISON Plex® BCY Assay. Twenty-eight (28) strains and isolates that represent the 14 reportable targets of the LIAISON Plex BCY Assay were tested individually by serially diluting each target in a simulated blood culture sample matrix. Testing was broken into two parts; Preliminary LoD and Confirmation LoD. The Preliminary LoD concentrations were evaluated using a 6 point 3-fold dilution series and testing of at least four replicates per dilution. The Preliminary LoD for each target was defined as the lowest concentration at which 100% of four replicates were positive for the intended reportable target. With the preliminary LoD results, a 3-point 3 fold dilution series was made. Twenty replicates of each applicable dilution series were tested. Two concentrations were required with 20 replicates each to help determine the confirmed LoD for each strain. The confirmed LoD for each organism was defined as the lower concentration at which ≥ 95% of the 20 replicates were positive for the intended reportable target. The confirmed LoD for each target tested is listed in the following Table 1.

| LIAISON PLEX Target | Organism | Source & ID | Confirmed<br>LoD (CFU/mL) |
|------------------------|------------------------|--------------|---------------------------|
| Candida albicans | Candida albicans | ATCC 10231 | 3.14E+04 |
| Candida albicans | Candida albicans | ATCC 14053 | 2.83E+05 |
| Candida kefyr | Candida kefyr | ATCC 8553 | 3.33E+03 |
| Candida kefyr | Candida kefyr | ATCC 4135 | 3.33E+03 |
| Candida famata | Candida famata | ATCC 20278 | 7.77E+02 |
| Candida famata | Candida famata | ATCC 60229 | 6.99E+03 |
| Candida dubliniensis | Candida dubliniensis | ATCC MYA-578 | 3.16E+03 |
| Candida dubliniensis | Candida dubliniensis | ATCC MYA-577 | 3.16E+03 |
| Candida glabrata | Candida glabrata | ATCC 15545 | 9.99E+03 |
| Candida glabrata | Candida glabrata | ATCC 15126 | 1.00E+04 |
| Candida krusei | Candida krusei | ATCC 6258 | 9.83E+03 |
| Candida krusei | Candida krusei | ATCC 28870 | 2.95E+04 |
| Candida guilliermondii | Candida guilliermondii | ATCC 22017 | 3.33E+03 |
| Candida guilliermondii | Candida guilliermondii | ATCC 34134 | 1.00E+04 |
| Candida lipolytica | Candida lipolytica | ATCC 20460 | 3.18E+04 |
| Candida lipolytica | Candida lipolytica | ATCC 20177 | 3.19E+04 |
| Candida lusitaniae | Candida lusitaniae | ATCC 42720 | 1.11E+04 |
| Candida lusitaniae | Candida lusitaniae | ATCC 34449 | 3.33E+04 |

# Table 1. LIAISON® PLEX BCY Assay Limit of Detection Results Summary

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| LIAISON PLEX Target | Organism | Source & ID | Confirmed<br>LoD (CFU/mL) |
|-----------------------------------------|--------------------------|-------------------|---------------------------|
| Candida haemulonii/<br>duobushaemulonii | Candida haemulonii | CBS 7375 | 3.51E+03 |
| | Candida duobushaemulonii | CBS 7798 | 3.51E+03 |
| Candida auris | Candida auris | CBS 10913 | 3.50E+03 |
| | Candida auris | CBS 12766 | 3.50E+03 |
| Candida parapsilosis | Candida parapsilosis | ATCC 28474 | 2.85E+04 |
| | Candida parapsilosis | ATCC 28475 | 9.50E+03 |
| Candida tropicalis | Candida tropicalis | ATCC 13803 | 3.51E+03 |
| | Candida tropicalis | ATCC 201380 | 3.51E+03 |
| Cryptococcus neoformans/<br>gattii | Cryptococcus neoformans | ATCC 208821 | 9.01E+04 |
| | Cryptococcus gattii | ATCC MYA-<br>4871 | 9.00E+04 |

# b. Precision/Reproducibility:

# Precision/Repeatability

Within-laboratory precision/repeatability for the LIAISON PLEX® BCY Assay was evaluated across a minimum of five non-consecutive days utilizing two operators, two LIAISON PLEX® Systems and one lot of the LIAISON PLEX® BCY Assay cartridges. The targets were randomized so that the target being tested was blinded to the operators performing the testing. Each target panel (Bottle/Ring Positive (RP), Bottle/Ring Positive + 8 hours (RP+8), Negative Blood Matrix (N), and Contrived-negative containing Escherichia coli + 8 hours (CN)) was run in triplicate by each operator for five non-consecutive days, totaling 15 replicates per target per operator.

The results of the within-laboratory precision / repeatability study are shown in Table 2.The results show the repeatability of the LIAISON PLEX® BCY Assay with an overall percent agreement of 100%, meaning the expected results were obtained for all analytes at all test levels across all samples, instruments, operators, and days.

| Reportable<br>Target | Panel | Cartridge<br>Lot | Target Positivity<br>Operator 1 | | Target Positivity<br>Operator 2 | | 95% C.I.<br>Overall | 95% C.I.<br>Lower | 95% C.I.<br>Upper |
|----------------------|---------------------------|------------------|---------------------------------|--------------|---------------------------------|--------------|---------------------|-------------------|-------------------|
| | | | Instrument 1 | Instrument 2 | Instrument 1 | Instrument 2 | | | |
| <i>C. albicans</i> | Ring Positive | 1 | 100% (7/7) | 100% (8/8) | 100% (6/6) | 100% (9/9) | 100% (30/30) | 88.7% | 100% |
| <i>C. albicans</i> | Ring Positive<br>+8 hours | 1 | 100% (8/8) | 100% (7/7) | 100% (5/5) | 100% (10/10) | 100% (30/30) | 88.7% | 100% |
| <i>C. albicans</i> | Negative<br>Blood Matrix | 1 | 0% (0/7) | 0% (0/8) | 0% (0/8) | 0% (0/7) | 0% (0/30) | 88.7% | 100% |

## Table 2. Within Laboratory Precision / Repeatability Confidence Interval

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| Reportable<br>Target | Panel | Cartridge<br>Lot | Operator 1 | | Operator 2 | | Overall | 95% C.I. | |
|------------------------------------|---------------------------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|----------|-------|
| | | | Instrument<br>1 | Instrument<br>2 | Instrument<br>1 | Instrument<br>2 | | Lower | Upper |
| C. tropicalis | Ring Positive | | 100% (7/7) | 100% (8/8) | 100% (6/6) | 100% (9/9) | 100%<br>(30/30) | 88.7% | 100% |
| | Ring Positive<br>+8 hours | | 100% (8/8) | 100% (7/7) | 100% (5/5) | 100%<br>(10/10) | 100%<br>(30/30) | 88.7% | 100% |
| | Negative<br>Blood Matrix | | 0% (0/7) | 0% (0/8) | 0% (0/8) | 0% (0/7) | 0%<br>(0/30) | 88.7% | 100% |
| C.<br>neoformans | Ring Positive | | 100% (7/7) | 100% (8/8) | 100% (6/6) | 100% (9/9) | 100%<br>(30/30) | 88.7% | 100% |
| | Ring Positive<br>+8 hours | | 100% (8/8) | 100% (7/7) | 100% (5/5) | 100%<br>(10/10) | 100%<br>(30/30) | 88.7% | 100% |
| | Negative<br>Blood Matrix | | 0% (0/7) | 0% (0/8) | 0% (0/8) | 0% (0/7) | 0%<br>(0/30) | 88.7% | 100% |
| Contrived<br>Negative<br>(E. coli) | N/A | | 0% (0/6) | 0% (0/9) | 0% (0/9) | 0% (0/6) | 0%<br>(0/30) | 88.7% | 100% |

# Lot-to-lot Reproducibility

Lot-to-lot reproducibility of the LIAISON PLX BCY Assay was evaluated by testing three different lots of LIAISON PLEX BCY Assay cartridges with one operator over five non-consecutive days, and with two runs per lot. The same target panels used for Precision/Repeatability were used for Lot-to-Lot reproducibility. The blinded reproducibility panels were tested in triplicate for each sample type by operator. Results of the Lot-to-Lot reproducibility are summarized below in Table 3. Overall percent agreement for Lot-to-Lot reproducibility was 100%.

## Table 3 Lot-to-Lot Reproducibility Confidence Intervals

| Reportable | Panel | Cartridge Lot | Target | 95% confidence interval | | | | | | | | | | | | | |
|-------------|--------------|--------------------------|--------------|--------------------------|--------------|--------------------------|--------------|-------|------|--------------------------|--------------|-------|------|---------|--------------|-------|------|
| Target | | | Positivity | Lower | Upper | | | | | | | | | | | | |
| C. albicans | RP | Lot 1 (051823106ADEVIUO) | 100% (15/15) | 79.6% | 100% | | | | | | | | | | | | |
| | | Lot 2 (032823106ADEVIUO) | 100% (15/15) | 79.6% | 100% | | | | | | | | | | | | |
| | | Lot 3 (061923106ADEVIUO) | 100% (15/15) | 79.6% | 100% | | | | | | | | | | | | |
| | | Overall | 100% (45/45) | 92.1% | 100% | | | | | | | | | | | | |
| | RP+8 | Lot 1 (051823106ADEVIUO) | 100% (15/15) | 79.6% | 100% | Lot 2 (032823106ADEVIUO) | 100% (15/15) | 79.6% | 100% | Lot 3 (061923106ADEVIUO) | 100% (15/15) | 79.6% | 100% | Overall | 100% (45/45) | 92.1% | 100% |
| | | | RP+8 | Lot 1 (051823106ADEVIUO) | 100% (15/15) | 79.6% | 100% | | | | | | | | | | |
| | | | | Lot 2 (032823106ADEVIUO) | 100% (15/15) | 79.6% | 100% | | | | | | | | | | |
| | | | | Lot 3 (061923106ADEVIUO) | 100% (15/15) | 79.6% | 100% | | | | | | | | | | |
| Overall | 100% (45/45) | | | 92.1% | 100% | | | | | | | | | | | | |

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complexity sim

LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission

| Reportable<br>Target | Panel | Cartridge Lot | Target<br>Positivity | 95% confidence interval | |
|----------------------|-------|--------------------------|----------------------|-------------------------|-------|
| Target | | | | Lower | Upper |
| C. tropicalis | RP | Lot 1 (051823106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Lot 2 (032823106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Lot 3 (061923106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Overall | 100% (45/45) | 92.1% | 100% |
| C. neoformans | RP+8 | Lot 1 (051823106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Lot 2 (032823106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Lot 3 (061923106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Overall | 100% (45/45) | 92.1% | 100% |
| Negative | RP | Lot 1 (051823106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Lot 2 (032823106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Lot 3 (061923106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Overall | 100% (45/45) | 92.1% | 100% |
| | RP+8 | Lot 1 (051823106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Lot 2 (032823106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Lot 3 (061923106ADEVIUO) | 100% (15/15) | 79.6% | 100% |
| | | Overall | 100% (45/45) | 92.1% | 100% |
| | CN | Lot 1 (051823106ADEVIUO) | 0% (0/15) | 79.6% | 100% |
| | | Lot 2 (032823106ADEVIUO) | 0% (0/15) | 79.6% | 100% |
| | | Lot 3 (061923106ADEVIUO) | 0% (0/15) | 79.6% | 100% |
| | | Overall | 0% (0/45) | 92.1% | 100% |
| | N | Lot 1 (051823106ADEVIUO) | 0% (0/15) | 79.6% | 100% |
| | | Lot 2 (032823106ADEVIUO) | 0% (0/15) | 79.6% | 100% |
| | | Lot 3 (061923106ADEVIUO) | 0% (0/15) | 79.6% | 100% |
| | | Overall | 0% (0/45) | 92.1% | 100% |

## Site-to-site Reproducibility

Site-to-site reproducibility of the LIAISON PLEX BCY Assay was evaluated by testing one lot of LIAISON PLEX BCY Assay cartridges with two operators at each of three sites over five nonconsecutive days. Four target panels were prepared and tested across all sites and operators to evaluate site-to-site reproducibility. The same target panels used for Precision/Repeatability and Lot-to-Lot reproducibility were used for Site-to-Site reproducibility. The blinded reproducibility panels were tested in triplicate for each sample type by each operator on each testing day.

Results of the site-to-site reproducibility study are summarized in Table 4. Reproducibility of

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the LIAISON PLEX® BCY Assay across three sites was 99.7%.

| Panel Type | Site | Results (% Agreement) | 95% C.I. |
|-------------------------|-----------|-----------------------|---------------|
| Ring Positive | Site 1 | 100% (30/30) | 94.0% - 100% |
| | Site 2 | 96.7% (29/30) | 83.3% - 99.4% |
| | Site 3 | 100% (30/30) | 88.6% - 100% |
| | All Sites | 98.9% (89/90) | 94.0% - 99.8% |
| Ring Positive + 8 hours | Site 1 | 100% (30/30) | 88.6% - 100% |
| | Site 2 | 100% (30/30) | 88.6% - 100% |
| | Site 3 | 100% (30/30) | 88.6% - 100% |
| | All Sites | 100% (90/90) | 95.9% - 100% |
| Negative Blood Matrix | Site 1 | 100% (30/30) | 88.6% - 100% |
| | Site 2 | 100% (30/30) | 88.6% - 100% |
| | Site 3 | 100% (30/30) | 88.6% - 100% |
| | All Sites | 100% (90/90) | 95.9% - 100% |
| Contrived Negative | Site 1 | 100% (30/30) | 88.6% - 100% |
| | Site 2 | 100% (30/30) | 88.6% - 100% |
| | Site 3 | 100% (30/30) | 88.6% - 100% |
| | All Sites | 100% (90/90) | 95.9% - 100% |
| Overall | | 99.7% (359/360) | 98.4% - 100% |

# Table 4. LIAISON® PLEX BCY Assay Site to Site Reproducibility Results

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Image /page/16/Picture/0 description: The image shows the logo for Luminex. The word "Luminex" is written in a bold, sans-serif font, with a red dot above the "i". Below the word "Luminex" is the tagline "complexity simplified.", written in a smaller, thinner font. The logo is simple and modern, and the red dot adds a pop of color.

- ﻥ Linearity/assay reportable range:
Not applicable. The LIAISON® PLEX Yeast Blood Culture Assay is a qualitative assay.

- d. Traceability, Stability, Expected values (controls, calibrators, or methods):
#### Controls:

Several controls are built into the assay and system to ensure identification of processing errors and to establish validity of test results.

#### Internal Controls

Each LIAISON® PLEX BCY Assay cartridge includes internal controls to ensure performance of sample preparation, amplification, and detection. Internal control is automatically added to the sample prior to initiation of sample preparation and assesses extraction, nucleic acid recovery, amplification, and detection. Finally, a post-amplification hybridization control serves as an indicator of successful hybridization. Internal control results are reported as Pass or Fail on the printed reports (see the following Table 5 for detailed explanations of each control result). Internal controls must generate a signal above the threshold in each internal reaction for the system to report a valid test result.

| Internal Control<br>Result | Explanation | Suggested Action |
|----------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Pass | Test was completed and internal controls were<br>successful, indicating that valid results were<br>generated. | Review and report result |
| Fail | One or more internal controls failed. | Repeat test with a new<br>cartridge |

## Table 5. Interpretation of Controls on the LIAISON® PLEX BCY Assay Report

## External Controls

Positive and negative external controls should be tested with each new lot or shipment of reagents, or monthly, (whichever occurs first), or in accordance with updated local, regional, state, and/or federal guidelines. Verified negative blood matrix can be used as the negative control. Previously characterized positive samples or verified negative blood matrix spiked with well characterized organisms may be used as the external positive control. External controls should be used in accordance with laboratory protocols and in accordance with local, state, and federal accrediting organizations, as applicable.

# Stability:

## Specimen Stability

Contrived specimen stability at incubated storage (33°C - 37°C), refrigerated (2°C - 8°C), and frozen (-80°C ± 15) storage was evaluated for use with the LIAISON" PLEX BCY Assay. Two reference panels, each made of three organisms, were tested at concentrations representing bottle positivity. The panels were then stored at incubated, refrigerated, or frozen temperature conditions. Testing occurred at various time points up to 1 month for

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LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission the frozen storage, up to 1 month for refrigerated storage, and up to 72 hours for incubated storage. Specimen stability was also evaluated for specimens grown in a continuous blood monitoring system by testing fresh blood bottle ring positive (RP) and blood bottle ring positive plus 12 hours (RP + 12) samples.

The results of this study demonstrated that specimens stored frozen (< -80°C) are stable for up to 1 month, specimens stored refrigerated (2°C - 8°C) are stable for up to 1 month and specimens stored at incubation (33°C - 37°C) are stable for up to 72 hours. Specimens incubated up to 12 hours after bottle ring positive were 100% detected.

#### Device Stability

A shelf-life study was conducted to evaluate the real-time stability of the LIAISON PLEX BCY Assay at the recommended storage conditions of room temperature (15°C - 30°C). Real-time stability was assessed using three Positive Control panels which each consisted of representative on-panel fungal organisms, and one Negative Control panel which consisted of negative blood matrix. Results of real-time stability demonstrated the LIAISON PLEX BCY Assay is stable for at least 3 months when stored at 15°C - 30°C.

Open-box stability of the LIAISON PLEX BCY Assay was also evaluated by testing four lots of LIAISON PLEX BCY Assay after removal from their foil pouches and stored at room temperature. The same Positive Control panels and Negative Control panel used for real-time stability were used for open-box stability. Results of open-box stability indicate the cartridges…