Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard molecular diagnostic techniques (nucleic acid extraction, PCR, hybridization, signal analysis) and does not mention AI or ML.

Therapeutic

No This device is an in vitro diagnostic test designed to detect and identify fungal organisms in blood cultures, aiding in initial diagnosis rather than providing direct treatment.

Diagnostic

Yes

The text explicitly states that the LIAISON PLEX Yeast Blood Culture (BCY) Assay is an "in vitro diagnostic test" and that its purpose is for "simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture," which "aids in the diagnosis of bloodstream infection."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of an instrument, a single-use disposable test cartridge, and a transfer pipette, in addition to the software that automates the process. This indicates the presence of hardware components.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicitly Stated in Intended Use: The "Intended Use / Indications for Use" section clearly states: "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."
Performed on Biological Samples: The test is performed on "positive blood culture" samples, which are biological specimens taken from the human body.
Used for Diagnosis: The intended use states that the detection and identification of fungal nucleic acids "aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information."
Analyzes Biological Properties: The device detects and identifies specific fungal nucleic acids, which are biological properties of the organisms present in the blood culture.

All of these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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.

Product codes

PEO, NSU

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use
For in vitro diagnostic use only.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A multi-site clinical study established the diagnostic accuracy of the LIAISON PLEX® BCY Assay for the detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture from blood culture media identified as positive by a continuous monitoring blood culture system and which contain fungal organisms as determined by Gram Stain. The clinical performance of the LIAISON PLEX BCY Assay was evaluated using a combination of prospectively collected de-identified remnant samples, preselected positive samples, and contrived samples.

A total of 3447 unique prospectively collected specimens were evaluated for their eligibility across four geographically diverse US clinical sites. Of these, 69 (1 specimen was excluded due to inconclusive gram stain result) prospective specimens that met the pre-determined inclusion criteria and exhibited yeast morphology following gram stain were enrolled in the study. Clinical runs and re-runs using the LIAISON PLEX® BCY Assay were tested on the LIAISON PLEX® System by trained operators at four sites. Prospective specimen testing occurred between June 2023 and October 2023.

As all targets exhibited low prevalence rates in the prospective specime specimen set was supplemented with pre-selected and contrived specimens. The 63 pre-selected specimens were remnant, de-identified specimens sourced from 6 different sites/vendors in the United States. The pre-selected specimens were characterized by an FDA cleared molecular assay prior to enrollment in the study. The pre-selected specimens were tested in a randomized, blinded manner with negative specimens at one site during October 2023.

A total of 829 specimens were contrived and tested. To minimize bias, contrived specimens were blinded, randomized, and tested along with negative clinical specimens at all four testing sites during June 2023.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Precision/Reproducibility
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 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.

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. Overall percent agreement for Lot-to-Lot reproducibility was 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. Reproducibility of the LIAISON PLEX® BCY Assay across three sites was 99.7%.

Clinical Performance Study
A multi-site clinical study established the diagnostic accuracy of the LIAISON PLEX® BCY Assay for the detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture from blood culture media identified as positive by a continuous monitoring blood culture system and which contain fungal organisms as determined by Gram Stain. The clinical performance of the LIAISON PLEX BCY Assay was evaluated using a combination of prospectively collected de-identified remnant samples, preselected positive samples, and contrived samples.
A total of 3447 unique prospectively collected specimens were evaluated for their eligibility across four geographically diverse US clinical sites. Of these, 69 prospective specimens met inclusion criteria. The specimen set was supplemented with pre-selected (n=63) and contrived (n=829) specimens.
Out of the 132 clinical specimens included in the prospective and pre-selected study analysis, 130 (98.5%) generated valid BCY Assay results on the first attempt. Two (1.5%) specimens with initial invalid results generated valid BCY results after a single retest. 132 specimens generated valid BCY results for a final success rate of 100.0% (132/132).
Out of the 829 specimens included in the contrived study analysis, 803 specimens (96.9%) generated valid BCY Assay results on the first attempt. There were 26 specimens (3.1%) with an invalid result on the initial run. Of the 26 specimens retested, 24 specimens generated a valid result after a single retest for a final success rate of 99.7% (827/829).
The invalid rate for prospective, pre-selected, and contrived specimens combined was 2.9% (28/961) after the initial run. After allowing for a single retest of any initial invalid results, 26 (2.7%) specimens generated valid BCY results. Two (0.2%) specimens remained invalid on repeat for an overall success rate of 99.8% (959/961).
The pre-defined acceptance criteria for the clinical study were: Sensitivity ≥ 90% for all targets, Specificity ≥95% for each target, and Failure rate ≤15%. All acceptance criteria were met successfully.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Prospective and Pre-Selected Specimens (Combined):

Candida albicans: Sensitivity / PPA 100.0% (34/34), Specificity / NPA 99.0% (97/98)
Candida auris: Sensitivity / PPA 100.0% (4/4), Specificity / NPA 100.0% (128/128)
Candida dubliniensis: NA for Sensitivity/PPA (0/0), Specificity / NPA 100.0% (132/132)
Candida famata: NA for Sensitivity/PPA (0/0), Specificity / NPA 100.0% (132/132)
Candida glabrata: Sensitivity / PPA 100.0% (46/46), Specificity / NPA 100.0% (86/86)
Candida guilliermondii: NA for Sensitivity/PPA (0/0), Specificity / NPA 100.0% (132/132)
Candida haemulonii/C. duobushaemulonii: NA for Sensitivity/PPA (0/0), Specificity / NPA 100.0% (132/132)
Candida kefyr: Sensitivity / PPA 100.0% (1/1), Specificity / NPA 100.0% (131/131)
Candida krusei: Sensitivity / PPA 100.0% (4/4), Specificity / NPA 100.0% (128/128)
Candida lipolytica: NA for Sensitivity/PPA (0/0), Specificity / NPA 100.0% (132/132)
Candida lusitaniae: Sensitivity / PPA 100.0% (2/2), Specificity / NPA 100.0% (130/130)
Candida parapsilosis: Sensitivity / PPA 100.0% (17/17), Specificity / NPA 99.1% (114/115)
Candida tropicalis: Sensitivity / PPA 100.0% (6/6), Specificity / NPA 97.6% (123/126)
Cryptococcus neoformans/Cryptococcus gattii: Sensitivity / PPA 100.0% (5/5), Specificity / NPA 100.0% (127/127)

Contrived Specimens:

Candida albicans: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 100.0% (777/777)
Candida auris: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 100.0% (777/777)
Candida dubliniensis: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 100.0% (777/777)
Candida famata: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 99.9% (776/777)
Candida glabrata: Positive Percent Agreement 100.0% (49/49), Negative Percent Agreement 100.0% (778/778)
Candida guilliermondii: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 100.0% (777/777)
Candida haemulonii/C. duobushaemulonii: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 100.0% (777/777)
Candida kefyr: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 100.0% (777/777)
Candida krusei: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 100.0% (777/777)
Candida lipolytica: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 100.0% (777/777)
Candida lusitaniae: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 100.0% (777/777)
Candida parapsilosis: Positive Percent Agreement 100.0% (50/50), Negative Percent Agreement 99.9% (776/777)
Candida tropicalis: Positive Percent Agreement 100.0% (49/49), Negative Percent Agreement 99.6% (775/778)
Cryptococcus neoformans/Cryptococcus gattii: Positive Percent Agreement 100.0% (100/100), Negative Percent Agreement 100.0% (727/727)

Predicate Device(s)

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

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

(a)
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.(b)
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).

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 (847) 400-9000

F. Proprietary and Established Names:

LIAISON PLEX® Yeast Blood Culture Assay

G. Regulatory Information:

| Product

Code	Classification	Regulation Section
PEO	II	21 CFR 866.3365 – Multiplex Nucleic Acid
Assay for Identification of Microorganisms
and Resistance Markers from Positive
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.

1. 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.

1. 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)
1. Predicate 510(k) number(s): K182690
1. 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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LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission

Comparison to Predicate

	Predicate Device:	Candidate Device:
Comparison
to Predicate
Device	GenMark ePlex Blood Culture Identification
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
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/
duobushaemulonii, Cryptococcus
neoformans/gatti
Measurand	Nucleic acid from Organisms detected	Nucleic acid from Organisms detected
Intended Use	The GenMark ePlex Blood Culture
Identification Fungal Pathogen (BCID-FP)
Panel is a qualitative nucleic acid multiplex
in vitro diagnostic test intended for use on
GenMark's ePlex Instrument for
simultaneous detection and identification of
multiple potentially pathogenic fungal
organisms in positive blood culture. The
ePlex BCID-FP Panel is performed directly on
blood culture samples identified as positive
by a continuous monitoring blood culture
system and which contains fungal
organisms.
The following fungal organisms are identified
using the ePlex BCID-FP Panel:	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 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/
duobushaemulonii Cryptococcus neoformans/gatti
	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 the ePlex BCID-FP Panel
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 the ePlex BCID-
FP Panel 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
ePlex BCID-FP Panel, susceptibility testing
and differentiation of mixed growth) and
clinical presentation must be taken into
consideration in the final diagnosis of
bloodstream infection.	The detection and identification of
specific fungal nucleic acids from
individuals exhibiting signs and/or
symptoms of bloodstream infection aids
in the diagnostic of bloodstream
infection when used in conjunction with
other clinical information. The results
from the 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.
Automated System
(Sample to Answer)	Automated	Same
Instrumentation	ePlex Instrument	LIAISON PLEX®
Sample Types	Blood Culture	Same

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

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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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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
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
LoD (CFU/mL) |
|-----------------------------------------|--------------------------|-------------------|---------------------------|
| Candida haemulonii/
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/
gattii | Cryptococcus neoformans | ATCC 208821 | 9.01E+04 |
| | Cryptococcus gattii | ATCC MYA-
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
Target | Panel | Cartridge
Lot | Target Positivity
Operator 1 | | Target Positivity
Operator 2 | | 95% C.I.
Overall | 95% C.I.
Lower | 95% C.I.
Upper |
|----------------------|---------------------------|------------------|---------------------------------|--------------|---------------------------------|--------------|---------------------|-------------------|-------------------|
| | | | Instrument 1 | Instrument 2 | Instrument 1 | Instrument 2 | | | |
| C. albicans | Ring Positive | 1 | 100% (7/7) | 100% (8/8) | 100% (6/6) | 100% (9/9) | 100% (30/30) | 88.7% | 100% |
| C. albicans | Ring Positive
+8 hours | 1 | 100% (8/8) | 100% (7/7) | 100% (5/5) | 100% (10/10) | 100% (30/30) | 88.7% | 100% |
| C. albicans | Negative
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
Target | Panel | Cartridge
Lot | Operator 1 | | Operator 2 | | Overall | 95% C.I. | |
|------------------------------------|---------------------------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|----------|-------|
| | | | Instrument
1 | Instrument
2 | Instrument
1 | Instrument
2 | | Lower | Upper |
| C. tropicalis | Ring Positive | | 100% (7/7) | 100% (8/8) | 100% (6/6) | 100% (9/9) | 100%
(30/30) | 88.7% | 100% |
| | Ring Positive
+8 hours | | 100% (8/8) | 100% (7/7) | 100% (5/5) | 100%
(10/10) | 100%
(30/30) | 88.7% | 100% |
| | Negative
Blood Matrix | | 0% (0/7) | 0% (0/8) | 0% (0/8) | 0% (0/7) | 0%
(0/30) | 88.7% | 100% |
| C.
neoformans | Ring Positive | | 100% (7/7) | 100% (8/8) | 100% (6/6) | 100% (9/9) | 100%
(30/30) | 88.7% | 100% |
| | Ring Positive
+8 hours | | 100% (8/8) | 100% (7/7) | 100% (5/5) | 100%
(10/10) | 100%
(30/30) | 88.7% | 100% |
| | Negative
Blood Matrix | | 0% (0/7) | 0% (0/8) | 0% (0/8) | 0% (0/7) | 0%
(0/30) | 88.7% | 100% |
| Contrived
Negative
(E. coli) | N/A | | 0% (0/6) | 0% (0/9) | 0% (0/9) | 0% (0/6) | 0%
(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
Target | Panel | Cartridge Lot Positivity | 95% |----------------------| | Target | C. tropicalis | | | | C. neoformans | | | | Negative | | | | | | | | | | | | | | | | Target
confidence interval | |
-------|--------------------------|----------------------|-------------------------|-------|
| | | | Lower | Upper |
| 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 | 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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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

Result	Explanation	Suggested Action
Pass	Test was completed and internal controls were
successful, indicating that valid results were
generated.	Review and report result
Fail	One or more internal controls failed.	Repeat test with a new
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 (4 This percent positivity reflects the percent positive control 1, which includes Candida albicans, Candida tropicalis, and Cryptococcus neoformans.

2 This percent positivity reflects the percent positive control 2, which includes Condida globrato, Candida guilliermondii, and Candida kefyr.

3 This percent positivity reflects the percent positivity of all replicates from the 5 bacteria strains tested.

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

| Manufacturer | Bottle
Manufacturer
Part Number | Bottle
Name | Bottle Lot | Percent Positivity | | | |
|--------------|---------------------------------------|----------------------------------------|------------|--------------------|---------------------------|---------------------------|--------------------------|
| | | | | NBM | Positive
Control
11 | Positive
Control
22 | Off
Panel
Targets3 |
| | 442024 | Bactec Plus
Standard
Anaerobic/F | 2186992 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | | Bactec Plus
Standard
Anaerobic/F | 2326552 | 20%
(1/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | 442021 | Bactec
Lytic/10
Anaerobic/F | 2227861 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | | Bactec
Lytic/10
Anaerobic/F | 3046048 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | 442023 | Bactec Plus
Aerobic/F | 2178710 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | | Bactec Plus
Aerobic/F | 3041879 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | 442020 | Bactec Peds
Plus | 2263255 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | | Bactec Peds
Plus | 3067576 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | 442027 | Bactec
Standard/10
Aerobic | 2227933 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | | Bactec
Standard/10
Aerobic | 3060893 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| BioMérieux | 259789 | BACT/Alert
SA | 0001059400 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | | | 0001059708 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | 410852 | BACT/Alert
FN Plus | 0004059160 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | | | 0004059844 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | 259790 | BACT/Alert
SN | 0001059860 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | | | 0001059900 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |
| | 410853 | BACT/Alert
PE Plus | 0004101300 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |

35

Image /page/35/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 small registered trademark symbol is next to the "x".

complexity simplified.

| Manufacturer | Bottle
Manufacturer
Part Number | Bottle
Name | Bottle Lot | Percent Positivity | | | |
|--------------|---------------------------------------|----------------|------------|--------------------|---------------------------|---------------------------|--------------------------|
| | | | | NBM | Positive
Control
11 | Positive
Control
22 | Off
Panel
Targets3 |
| | | | 0004101532 | 0%
(0/5) | 100%
(5/5) | 100%
(5/5) | 0%
(0/10) |

3. Clinical Performance:

A multi-site clinical study established the diagnostic accuracy of the LIAISON PLEX® BCY Assay for the detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture from blood culture media identified as positive by a continuous monitoring blood culture system and which contain fungal organisms as determined by Gram Stain. The clinical performance of the LIAISON PLEX BCY Assay was evaluated using a combination of prospectively collected de-identified remnant samples, preselected positive samples, and contrived samples.

A total of 3447 unique prospectively collected specimens were evaluated for their eligibility across four geographically diverse US clinical sites. Of these, 69 (1 specimen was excluded due to inconclusive gram stain result) prospective specimens that met the pre-determined inclusion criteria and exhibited yeast morphology following gram stain were enrolled in the study. Clinical runs and re-runs using the LIAISON PLEX® BCY Assay were tested on the LIAISON PLEX® System by trained operators at four sites. Prospective specimen testing occurred between June 2023 and October 2023.

As all targets exhibited low prevalence rates in the prospective specime specimen set was supplemented with pre-selected and contrived specimens. The 63 pre-selected specimens were remnant, de-identified specimens sourced from 6 different sites/vendors in the United States. The pre-selected specimens were characterized by an FDA cleared molecular assay prior to enrollment in the study. The pre-selected specimens were tested in a randomized, blinded manner with negative specimens at one site during October 2023.

Out of the 132 clinical specimens included in the prospective and pre-selected study analysis, 130 (98.5%) generated valid BCY Assay results (i.e., Detected or Not Detected) on the first attempt. Two (1.5%) specimens with initial invalid results generated valid BCY results after a single retest. 132 specimens generated valid BCY results for a final success rate of 100.0% (132/132).

Table 16 provides a summary of the general demographic information of the 69 prospectively collected specimens that were included in the clinical study.

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Image /page/36/Picture/0 description: The image shows the logo for Luminex. The word "Luminex" is written in a bold, sans-serif font, with the "i" dotted by a red circle. The logo is simple and modern, and the red dot adds a pop of color. The logo also has a registered trademark symbol.

LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission Table 16 - Demographic Information for Prospectively collected specimens

Gender	Site 01	Site 02	Site 03	Site 04	All Sites
Male	24(57.1%)	6(54.5%)	5(45.5%)	1(20.0%)	36(52.2%)
Female	17(40.5%)	5(45.5%)	6(54.5%)	4(80.0%)	32(46.4%)
Gender Unknown	1(2.4%)	0(0.0%)	0(0.0%)	0(0.0%)	1(1.4%)
Total	42(100.0%)	11(100.0%)	11(100.0%)	5(100.0%)	69(100.0%)
Age (years)
0-1	2(4.8%)	0(0.0%)	0(0.0%)	1(20.0%)	3(4.3%)
>1-5	0(0.0%)	0(0.0%)	0(0.0%)	0(0.0%)	0(0.0%)
>5-21	0(0.0%)	1(9.1%)	0(0.0%)	0(0.0%)	1(1.4%)
>21-65	21(50.0%)	9(81.8%)	8(72.7%)	3(60.0%)	41(59.4%)
>65	18(42.9%)	1(9.1%)	3(27.3%)	1(20.0%)	23(33.3%)
Age Unknown	1(2.4%)	0(0.0%)	0(0.0%)	0(0.0%)	1(1.4%)
Total	42(100.0%)	11(100.0%)	11(100.0%)	5(100.0%)	69(100.0%)
Subject Status
Emergency Room	0(0.0%)	1(9.1%)	4(36.4%)	0(0.0%)	5(7.2%)
Hospitalized	0(0.0%)	10(90.9%)	7(63.6%)	5(100.0%)	22(31.9%)
Status Unknown	42(100.0%)	0(0.0%)	0(0.0%)	0(0.0%)	42(60.9%)
Total	42(100.0%)	11(100.0%)	11(100.0%)	5(100.0%)	69(100.0%)
Blood Culture
Bottle type
BD BACTEC Lytic
Anaerobic	0(0.0%)	3(27.3%)	0(0.0%)	0(0.0%)	3(4.3%)
BD BACTEC Plus
Aerobic	0(0.0%)	8(72.7%)	6(54.5%)	0(0.0%)	14(20.3%)
BD BACTEC
Standard Aerobic	0(0.0%)	0(0.0%)	5(45.5%)	0(0.0%)	5(7.2%)
BacT/ALERT FA
Plus	40(95.2%)	0(0.0%)	0(0.0%)	0(0.0%)	40(58.0%)
BacT/ALERT FN
Plus	1(2.4%)	0(0.0%)	0(0.0%)	0(0.0%)	1(1.4%)
BacT/ALERT PF
Plus	1(2.4%)	0(0.0%)	0(0.0%)	1(20.0%)	2(2.9%)
BacT/ALERT SA
Standard Aerobic	0(0.0%)	0(0.0%)	0(0.0%)	3(60.0%)	3(4.3%)
BacT/ALERT SN
Standard Anaerobic	0(0.0%)	0(0.0%)	0(0.0%)	1(20.0%)	1(1.4%)
Bottle Type Total	42(100.0%)	11(100.0%)	11(100.0%)	5(100.0%)	69(100.0%)

Table 17 provides a summary of the general demographic information of the 63 pre-selected collected specimens that were included in the clinical study.

37

Image /page/37/Picture/0 description: The image shows the word "Luminex" in bold, black font. There is a red dot above the "i" in "Luminex". A registered trademark symbol is located to the right of the "x" in "Luminex".

complexity simplified.

Table 17 - Demographic Information for Pre-Selected Clinical Specimens
	# Samples (%)
Gender
Male	24(38.1%)
Female	25(39.7%)
Gender Unknown	14(22.2%)
Total	63(100.0%)
Age (years)
0-1	0(0.0%)
>1-5	1(1.6%)
>5-21	0(0.0%)
>21-65	27(42.9%)
>65	19(30.2%)
Age Unknown	16(25.4%)
Total	63(100.0%)
Subject Status
Hospitalized	2(3.2%)
Status Unknown	61(96.8%)
Total	63(100.0%)
Blood Culture Bottle Type
BD BACTEC Lytic Anaerobic	2(3.2%)
BD BACTEC Plus Aerobic	17(27.0%)
BD BACTEC Standard Aerobic	29(46.0%)
Bottle Type Unknown	15(23.8%)
Total	63(100.0%)

A total of 829 specimens were contrived and tested. To minimize bias, contrived specimens were blinded, randomized, and tested along with negative clinical specimens at all four testing sites during June 2023. Results from contrived specimens were analyzed separately from the prospective and pre-selected data sets.

Out of the 829 specimens included in the contrived study analysis, 803 specimens (96.9%) generated valid BCY Assay results (i.e., Detected or Not Detected) on the first attempt. There were 26 specimens (3.1%) with an invalid result on the initial run. Of the 26 specimens retested, 24 specimens generated a valid result after a single retest for a final success rate of 99.7% (827/829).

The invalid rate for prospective, pre-selected, and contrived specimens combined was 2.9% (28/961) after the initial run. After allowing for a single retest of any initial invalid results, 26 (2.7%) specimens generated valid BCY results. Two (0.2%) specimens remained invalid on repeat for an overall success rate of 99.8% (959/961).

For each target in the BCY Assay Panel, the diagnostic performance of the BCY Assay was determined using Sensitivity/PPA and Specificity/NPA, along with the associated 95% confidence intervals, (95% Cl as compared to the reference method). The results of the combined prospective and pre-selected specimen analysis are summarized in Table 18. The performance of the BCY Assay for contrived specimens is presented separately in Table 19.

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Image /page/38/Picture/0 description: The image shows the Luminex logo. The word "Luminex" is in bold, black font, with a red dot above the "i". Below the logo is the tagline "complexity simplified." in a smaller, black font with a red dot at the end.

		Sensitivity / PPA1			Specificity / NPA2
Pathogen Target		TP /
(TP+FN)	Sensitivity
/ PPA1	95% CI	TN /
(TN+FP)	Specificity
/ NPA2	95% CI
	Prospective	17/17	100.0%	81.6%-
100.0%	51/52	98.1%	89.9%-
99.7%
Candida albicans	Pre-selected	17/17	100.0%	81.6%-
100.0%	46/46	100.0%	92.3%-
100.0%
	Combined	34/34	100.0%	89.8%-
100.0%	97/98	99.0%	94.4%-
99.8%
	Prospective	4/4	100.0%	51.0%-
100.0%	65/65	100.0%	94.4%-
100.0%
Candida auris	Pre-selected	0/0	NA	NA	63/63	100.0%	94.3%-
100.0%
	Combined	4/4	100.0%	51.0%-
100.0%	128/128	100.0%	97.1%-
100.0%
	Prospective	0/0	NA	NA	69/69	100.0%	94.7%-
100.0%
Candida
dubliniensis	Pre-selected	0/0	NA	NA	63/63	100.0%	94.3%-
100.0%
	Combined	0/0	NA	NA	132/132	100.0%	97.2%-
100.0%
	Prospective	0/0	NA	NA	69/69	100.0%	94.7%-
100.0%
Candida famata	Pre-selected	0/0	NA	NA	63/63	100.0%	94.3%-
100.0%
	Combined	0/0	NA	NA	132/132	100.0%	97.2%-
100.0%
	Prospective	25/25	100.0%	86.7%-
100.0%	44/44	100.0%	92.0%-
100.0%
Candida glabrata	Pre-selected	21/21	100.0%	84.5%-
100.0%	42/42	100.0%	91.6%-
100.0%
	Combined	46/46	100.0%	92.3%-
100.0%	86/86	100.0%	95.7%-
100.0%
	Prospective	0/0	NA	NA	69/69	100.0%	94.7%-
100.0%
Candida
guilliermondii	Pre-selected	0/0	NA	NA	63/63	100.0%	94.3%-
100.0%
	Combined	0/0	NA	NA	132/132	100.0%	97.2%-
100.0%
Candida
haemulonii/C.
duobushaemulon
ii	Prospective	0/0	NA	NA	69/69	100.0%	94.7%-
100.0%
	Pre-selected	0/0	NA	NA	63/63	100.0%	94.3%-
100.0%
	Combined	0/0	NA	NA	132/132	100.0%	97.2%-
100.0%
	Prospective	1/1	100.0%	20.7%-
100.0%	68/68	100.0%	94.7%-
100.0%
Candida kefyr	Pre-selected	0/0	NA	NA	63/63	100.0%	94.3%-
100.0%
LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission
			Sensitivity / PPA1		Specificity / NPA2
Pathogen Target		TP /
(TP+FN)	Sensitivity
/ PPA1	95% CI	TN /
(TN+FP)	Specificity
/ NPA2	95% CI
	Combined	1/1	100.0%	20.7%-
100.0%	131/131	100.0%	97.2%-
100.0%
	Prospective	3/3	100.0%	43.9%-
100.0%	66/66	100.0%	94.5%-
100.0%
Candida krusei	Pre-selected	1/1	100.0%	20.7%-
100.0%	62/62	100.0%	94.2%-
100.0%
	Combined	4/4	100.0%	51.0%-
100.0%	128/128	100.0%	97.1%-
100.0%
	Prospective	0/0	NA	NA	69/69	100.0%	94.7%-
100.0%
Candida lipolytica	Pre-selected	0/0	NA	NA	63/63	100.0%	94.3%-
100.0%
	Combined	0/0	NA	NA	132/132	100.0%	97.2%-
100.0%
Candida
lusitaniae	Prospective	2/2	100.0%	34.2%-
100.0%	67/67	100.0%	94.6%-
100.0%
	Pre-selected	0/0	NA	NA	63/63	100.0%	94.3%-
100.0%
	Combined	2/2	100.0%	34.2%-
100.0%	130/130	100.0%	97.1%-
100.0%
	Prospective	11/11	100.0%	74.1%-
100.0%	57/58	98.3%	90.9%-
99.7%
Candida
parapsilosis	Pre-selected	6/6	100.0%	61.0%-
100.0%	57/57	100.0%	93.7%-
100.0%
	Combined	17/17	100.0%	81.6%-
100.0%	114/1154	99.1%	95.2%-
99.8%
Candida
tropicalis	Prospective	6/6	100.0%	61.0%-
100.0%	60/63	95.2%	86.9%-
98.4%
	Pre-selected	0/0	NA	NA	63/63	100.0%	94.3%-
100.0%
	Combined	6/6	100.0%	61.0%-
100.0%	123/1265	97.6%	93.2%-
99.2%
	Prospective	0/0	NA	NA	69/69	100.0%	94.7%-
100.0%
Cryptococcus
neoformans/Cryp
tococcus gattii	Pre-selected	5/5	100.0%	56.6%-
100.0%	58/58	100.0%	93.8%-
100.0%
	Combined	5/5	100.0%	56.6%-
100.0%	127/127	100.0%	97.1%-
100.0%

Table 18. LIAISON PLEX BCY Assay Performance with Prospective and Pre-Selected Specimens

39

Image /page/39/Picture/0 description: The image shows the logo for Luminex. The word "Luminex" is written in a bold, sans-serif font. There is a red dot above the "i" in Luminex. The logo is simple and modern.

1 Sensitivity is designated for prospective sample testing, while PPA is designated for pre-selected sample testing. 2 Specificity is designated for prospective sample testing, while NPA is designated for pre-selected sample testing.

3The one Candida albicans False Positive was positive by a cleared molecular assay.

4The one Candida parapsilosis False Positive was positive by a cleared molecular assay.

5One out of three Candida tropicalis False Positive by a cleared molecular assay.

40

Image /page/40/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. The logo is simple and modern.

LIAISON PLEX® Yeast Blood Culture Assay Traditional 510(k) Submission Table 19 – LIAISON PLEX BCY Assay Performance with Contrived Specimens

Pathogen Target	Positive Percent Agreement			Negative Percent Agreement
Analyte	TP / (TP+FN)	PPA	95% CI	TN / (TN+FP)	NPA	95% CI
Candida albicans	50/50	100.0%	92.9%- 100.0%	777/777	100.0%	99.5%- 100.0%
Candida auris	50/50	100.0%	92.9%- 100.0%	777/777	100.0%	99.5%- 100.0%
Candida dubliniensis	50/50	100.0%	92.9%- 100.0%	777/777	100.0%	99.5%- 100.0%
Candida famata	50/50	100.0%	92.9%- 100.0%	776/7771	99.9%	99.3%- 100.0%
Candida glabrata	49/49	100.0%	92.7%- 100.0%	778/778	100.0%	99.5%- 100.0%
Candida guilliermondii	50/50	100.0%	92.9%- 100.0%	777/777	100.0%	99.5%- 100.0%
Candida haemulonii/C. duobushaemulonii	50/50	100.0%	92.9%- 100.0%	777/777	100.0%	99.5%- 100.0%
Candida kefyr	50/50	100.0%	92.9%- 100.0%	777/777	100.0%	99.5%- 100.0%
Candida krusei	50/50	100.0%	92.9%- 100.0%	777/777	100.0%	99.5%- 100.0%
Candida lipolytica	50/50	100.0%	92.9%- 100.0%	777/777	100.0%	99.5%- 100.0%
Candida lusitaniae	50/50	100.0%	92.9%- 100.0%	777/777	100.0%	99.5%- 100.0%
Candida parapsilosis	50/50	100.0%	92.9%- 100.0%	776/7772	99.9%	99.3%- 99.9%
Candida tropicalis	49/49	100.0%	92.7%- 100.0%	775/7783	99.6%	98.9%- 100.0%
Cryptococcus neoformans/Cryptococcus gattii	100/100	100.0%	96.3%- 100.0%	727/727	100.0%	99.5%- 100.0%

The clinical performance of the LIAISON PLEX® BCY Assay was compared to the standard of care culture followed by identification by Matrix Assisted Laser Desorption/lonization coupled to time-of-flight Mass Spectrometry (MALDI-TOF MS) for all targets, as summarized below in Table 20.

41

Image /page/41/Picture/0 description: The image shows the logo for Luminex. The word "Luminex" is written in a bold, sans-serif font, with the letters slightly slanted to the right. There is a red dot above the "i" in "Luminex". The logo is simple and modern.

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

LIAISON PLEX® BCY Assay Target	Comparator Method
Candida albicans	Standard of Care culture followed by
identification by MALDI-TOF MS
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 (1)
Cryptococcus neoformans / gattii

Table 20 - Reference Method for the LIAISON PLEX BCY Assay Clinical Study

The pre-defined acceptance criteria for the clinical study were defined as follows:

The assay shall achieve a target Sensitivity of ≥ 90% for all targets. .
The Specificity for each target should be established at a level of ≥95%. .
Failure rate shall be ≤15%. .

Acceptance Criteria are based on Arms 1, 2, and 3 combined. All acceptance criteria were met successfully.

The study results demonstrate that the diagnostic accuracy of the BCY Assay is acceptable for the safe and effective detection and identification of fungal pathogens from blood culture media identified as positive by a continuous monitoring blood culture system and which contain fungal organisms as determined by Gram Stain from patients exhibiting clinical signs and symptoms of bloodstream infection.

42

Image /page/42/Picture/0 description: The image shows the Luminex logo. The word "Luminex" is in bold, black font, with a red dot above the "i". Below the logo is the tagline "complexity simplified." in a smaller, lighter font.

M. Proposed Labeling:

The labeling provided in the submission satisfies the requirements of 21 CFR 809.10.

N. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.