(210 days)
Not Found
Yes
The device description explicitly states that the final score is "derived from computational integration of the measurements of the three proteins". While it doesn't use the terms AI or ML, the concept of computationally integrating multiple biological markers to generate a diagnostic score is a common application area for ML algorithms in diagnostics. The predicate device (K210254) is the MeMed BV System, which is known to utilize a machine learning algorithm for its score calculation. This strongly suggests the DiaSorin LIAISON® MeMed BV® assay, which generates the same score, incorporates similar computational methods, likely including ML.
No.
The device is an in vitro diagnostic (IVD) assay intended to differentiate bacterial from viral infection; it does not provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "an automated in vitro diagnostic semi-quantitative assay" and is "intended for use... as an aid to differentiate bacterial from viral infection."
No
The device is an in vitro diagnostic assay that measures proteins using chemiluminescent immunoassay technology and requires the use of a specific automated analyzer (LIAISON® XL Analyzer) and reagent packs. While it generates a score computationally, the core function relies on physical and chemical processes and hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The DiaSorin LIAISON® MeMed BV® is an automated in vitro diagnostic semi-quantitative assay..." and "The control set is intended for in vitro diagnostic use in a professional laboratory only."
- Purpose: The device is intended to measure specific substances (TRAIL, IP-10, and CRP) in biological samples (serum) to provide information that aids in the diagnosis or differentiation of bacterial from viral infections. This is a core function of an in vitro diagnostic device.
- Sample Type: It uses serum samples, which are biological specimens taken from the human body.
- Testing Location: It is intended for use in a professional laboratory setting, which is typical for IVDs.
- Clinical Context: The results are intended to be used "in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection," indicating its role in the diagnostic process.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The DiaSorin LIAISON® MeMed BV® is an automated in vitro diagnostic semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The LIAISON® MeMed BV® assay is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for seven days or less. The LIAISON® MeMed BV® assay generates a numeric score that falls within discrete interpretation ranges based on the increasing likelihood of bacterial infection. The assay has to be performed on the automated LIAISON® XL Analyzer.
The DiaSorin LIAISON® MeMed BV® Control Set is intended for use as assayed quality control to monitor the performance of the DiaSorin LIAISON® MeMed BV® assay. The performance characteristics of the LIAISON® controls have not been established for any other assays or instrument platforms different from the automated LIAISON® XL Analyzer. The control set is intended for in vitro diagnostic use in a professional laboratory only.
Product codes (comma separated list FDA assigned to the subject device)
QPS, QCH
Device Description
The LIAISON MeMed BV assay consists of three individual chemiluminescence immunoassay (CLIA) for quantitative determination of TRAIL, IP-10, and CRP. The LIAISON MeMed BV test result is a score between 0 and 100 derived from computational integration of the measurements of the three proteins TRAIL, IP-10, and CRP, where low scores are indicative of viral infection and high score of bacterial infection. All three reagent packs must be the same lot and present at the same time on the same instrument used for sample testing. All three reagent packs are individually calibrated and quality controlled. Specimens are to be assigned to the MMBV assay protocol where all three reagent packs will be utilized to provide combined results and a final score.
The TRAIL reagent pack uses a monoclonal antibody for capture of TRAIL and a polyclonal antibody for the detection of TRAIL. The assay incubates sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the TRAL. Following the incubation, an isoluminol conjugated polyconal antibody that recognizes TRAIL is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of TRAL present in the calibrators, controls or samples. The result of the TRAIL reagent pack is only used to calculate a final LIAISON MeMed BV Score and should not be used individually for diagnosis.
The IP-10 reagent pack uses a monoclonal antibody for the capture of IP-10 and a polyclonal antibody for the detection of IP-10. The assay incubates sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the IP-10. Following the incubation, an isoluminol conjugated polyclonal antibody that recognizes IP-10 is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of IP-10 present in the calibrators, controls or samples. The result of the IP-10 reagent pack is only used to calculate a final LIAISON MeMed BV Score and should not be used individually for diagnosis.
The CRP reagent pack uses monoclonal antibodies for capture and detection of CRP. First the patient serum sample is pre-diluted 1:196 with assay buffer. The assay incubates the pre-diluted sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the CRP. Following the incubation, an isoluminol conjugated monoclonal antibody that recognizes CRP is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of CRP present in the calibrators, controls or samples. The result of the CRP reagent pack is only used to calculate a final LIAISON "MeMed BV" Score and should not be used individually for diagnosis.
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
Adult and pediatric serum samples.
Intended User / Care Setting
Patients presenting to the emergency department or urgent care center and with samples collected at hospital admission. For in vitro diagnostic use in a professional laboratory 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 total of 285 serum samples from patients presenting with signs and symptoms suggestive of acute bacterial or viral infection were included in the study. Study populations included samples taken at hospital admission, Emergency Department and Urgent Care Centers. Patients ranged in age from 5 months to 92 years of age with 54.7% females (156) and 45.3% males (129). The most common clinical syndrome was respiratory tract infections (67%) which included both upper and lower respiratory tract infections.
Primary Endpoint Analysis: The results of the LIAISON "MeMed BV" assay were compared to physician expert adjudication. Expert adjudication was used as the comparator method. Expert adjudication was determined through the process in which physicians were forced to make a bacterial, viral, or noninfectious diagnosis with categorization of patients. Panelists for each subject adjudication were drawn from a pool of 21 international experts, who were clinicians with at least 7 years of relevant clinical experience. Each panel comprised at least three experts who independently adjudicated the etiologic label for each patient. The etiologic label of the adjudicator was based on anonymized patient data. Importantly, the adjudicators were blinded to the MeMed BV result. The adjudicators were blinded to CRT and PCT results for the primary endpoint.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CLINICAL AGREEMENT (Primary Endpoint Analysis):
Study Type: Clinical agreement study comparing LIAISON MeMed BV results to physician expert adjudication.
Sample Size: 285 serum samples.
Key Results: A significant trend is demonstrated between the LIAISON MeMed BV SCORE and the increasing likelihood of bacterial infections across the SCORE bins.
- BIN 5 (90 ≤ score ≤ 100, Bacterial): N=33, 66.7% Reference Bacterial, Likelihood Ratio of Bacterial Basis Each Bin (95% CI): 13.00 (7.09-25.83)
- BIN 4 (65
§ 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
(a)
Identification. A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the device's detailed Indications for Use statement describing what the device detects and measures, the results provided to the user, whether the measure is qualitative and/or quantitative, the clinical indications for which the test is to be used, and the specific population(s) for which the device use is intended.
(2) Premarket notification submissions must include detailed documentation of the device description, including (as applicable), all device components, software, ancillary reagents required but not provided, explanation of the device principle and methodology, and for molecular devices include detailed documentation of the primer/probe sequence, design, and rationale for sequence selection.
(3) Premarket notification submissions must include detailed documentation of applicable analytical studies, such as, analytical sensitivity (Limit of Detection, Limit of Blank, and Limit of Quantitation), precision, reproducibility, analytical measuring range, interference, cross-reactivity, and specimen stability.
(4) Premarket notification submissions must include detailed documentation of a prospective clinical study or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information:
(i) Results must demonstrate adequate device performance relative to a well-accepted comparator.
(ii) Clinical sample results must demonstrate consistency of device output throughout the device measuring range likely to be encountered in the Intended Use population.
(iii) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the Indications for Use(s), and results of all statistical analyses.
(5) Premarket notification submissions must include evaluation of the level of the non-microbial analyte in asymptomatic patients with demographic characteristics (
e.g., age, racial, ethnic, and gender distribution) similar to the Intended Use population.(6) As part of the risk management activities performed under 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling, and a detailed explanation of the interpretation of the limitations of the samples (
e.g., collected on day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10) compliant labeling.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
DiaSorin Inc. Emily Peterson Principal Regulatory Affairs Specialist 1951 Northwestern Avenue Stillwater, Minnesota 55082
July 14, 2022
Re: K213936
Trade/Device Name: LIAISON MeMed BV, LIAISON MeMed BV Control Set Regulation Number: 21 CFR 866.3215 Regulation Name: Device To Detect And Measure Non-Microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis Regulatory Class: Class II Product Code: QPS Dated: December 15, 2021 Received: December 16, 2021
Dear Emily Peterson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K213936
Device Name LIAISON MeMed BV LIAISON MeMed BV Control Set
Indications for Use (Describe)
The DiaSorin LIAISON® MeMed BV® is an automated in vitro diagnostic semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The LIAISON® MeMed BV® assay is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for seven days or less. The LIAISON® MeMed BV® assay generates a numeric score that falls within discrete interpretation ranges based on the increasing likelihood of bacterial infection. The assay has to be performed on the automated LIAISON® XL Analyzer.
The DiaSorin LIAISON® MeMed BV® Control Set is intended for use as assayed quality control to monitor the performance of the DiaSorin LIAISON® MeMed BV® assay. The performance characteristics of the LIAISON® controls have not been established for any other assays or instrument platforms different from the automated LIAISON® XL Analyzer. The control set is intended for in vitro diagnostic use in a professional laboratory only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
| SUBMITTED BY: | Emily Peterson
DiaSorin Inc.
1951 Northwestern Avenue
Stillwater, MN 55082-0285
Phone (651) 351-5628
Fax (651) 351-5669
Email emily.peterson@diasorin.com |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® MeMed BV®
LIAISON® MeMed BV® Control Set |
| Common Names/Descriptions: | LIAISON® MeMed BV®
LIAISON® MeMed BV® Control Set |
| Classification Names: | Immunoasssay for Host Biomarkers o
Infection |
| Product Code: | QPS
QCH |
| Predicate Device: | MeMed BV® |
INTENDED USE:
The DiaSorin LIAISON MeMed BV is an automated in vitro diagnostic semi-quantitative assay that uses chemiluminescent immunoasay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The LIAISON MeMed BV assay is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for seven days or less. The LIAISON MeMed BV assay generates a numeric score that falls within discrete interpretation ranges based on the increasing likelihood of bacterial infection. The assay has to be performed on the LIAISON XL Analyzer.
The DiaSorin LIAISON" MeMed BV Control Set is intended for use as assayed quality control to monitor the performance of the DiaSorin LIAISON MeMed BV assay. The performance characteristics of the LIAISON controls have not been established for any other assays or instrument platforms different from the automated LIAISON *XL Analyzer. The control set is intended for in vitro diagnostic use in a professional laboratory only.
4
KIT DESCRIPTION:
The LIAISON MeMed BV assay consists of three individual chemiluminescence immunoassay (CLIA) for quantitative determination of TRAIL, IP-10, and CRP. The LIAISON MeMed BV test result is a score between 0 and 100 derived from computational integration of the measurements of the three proteins TRAIL, IP-10, and CRP, where low scores are indicative of viral infection and high score of bacterial infection. All three reagent packs must be the same lot and present at the same time on the same instrument used for sample testing. All three reagent packs are individually calibrated and quality controlled. Specimens are to be assigned to the MMBV assay protocol where all three reagent packs will be utilized to provide combined results and a final score.
The TRAIL reagent pack uses a monoclonal antibody for capture of TRAIL and a polyclonal antibody for the detection of TRAIL. The assay incubates sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the TRAL. Following the incubation, an isoluminol conjugated polyconal antibody that recognizes TRAIL is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of TRAL present in the calibrators, controls or samples. The result of the TRAIL reagent pack is only used to calculate a final LIAISON MeMed BV Score and should not be used individually for diagnosis.
The IP-10 reagent pack uses a monoclonal antibody for the capture of IP-10 and a polyclonal antibody for the detection of IP-10. The assay incubates sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the IP-10. Following the incubation, an isoluminol conjugated polyclonal antibody that recognizes IP-10 is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of IP-10 present in the calibrators, controls or samples. The result of the IP-10 reagent pack is only used to calculate a final LIAISON *MeMed BV *Score and should not be used individually for diagnosis.
The CRP reagent pack uses monoclonal antibodies for capture and detection of CRP. First the patient serum sample is pre-diluted 1:196 with assay buffer. The assay incubates the pre-diluted sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the CRP. Following the incubation, an isoluminol conjugated monoclonal antibody that recognizes CRP is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of CRP present in the calibrators, controls or samples. The result of the CRP reagent pack is only used to calculate a final LIAISON "MeMed BV" Score and should not be used individually for diagnosis.
SUBSTANTIAL EQUIVALENCE:
The DiaSorin LIAISON MeMed BV is substantially equivalent in principle and performance to the MeMed Diagnostics Ltd. MeMed BV assay which was FDA cleared on September 01, 2021-510k K210254.
5
The following comparison of the use, technology, and performance presented in Table 1 supports the Statement of Equivalence between the LIAISON® MeMed BV assay to the MeMed Diagnostics Ltd. MeMed BV test system. The differences (presented in Table 2) in technology do not raise additional concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent.
| Table of Similarities | ||
|---|---|---|
| Feature | Candidate Device | |
| LIAISON® MeMed BV® | Predicate Device | |
| MeMed BV® System - K210254 | ||
| Intended Use | The DiaSorin LIAISON® MeMed BV® is an | |
| automated in vitro diagnostic semi-quantitative | ||
| assay that uses chemiluminescent immunoassay | ||
| (CLIA) technology to measure three non- | ||
| microbial (host) proteins (TRAIL, IP-10, and CRP) | ||
| in adult and pediatric serum samples and is | ||
| intended for use in conjunction with clinical | ||
| assessments and other laboratory findings as an | ||
| aid to differentiate bacterial from viral | ||
| infection. The LIAISON® MeMed BV® assay is | ||
| indicated for use in patients presenting to the | ||
| emergency department or urgent care center | ||
| and with samples collected at hospital | ||
| admission from patients with suspected acute | ||
| bacterial or viral infection, who have had | ||
| symptoms for seven days or less. The LIAISON® | ||
| MeMed BV® assay generates a numeric score | ||
| that falls within discrete interpretation ranges | ||
| based on the increasing likelihood of bacterial | ||
| infection. | The MeMed BV® test is an automated semi- | |
| quantitative immunoassay that measures three | ||
| non-microbial (host) proteins (TRAIL, IP-10, and | ||
| CRP) in adult and pediatric serum samples and | ||
| is intended for use in conjunction with clinical | ||
| assessments and other laboratory findings as an | ||
| aid to differentiate bacterial from viral | ||
| infection. The MeMed BV® is indicated for use in | ||
| patients presenting to the emergency | ||
| department or urgent care center and with | ||
| samples collected at hospital admission from | ||
| patients with suspected acute bacterial or viral | ||
| infection, who have had symptoms for less than | ||
| seven days. The MeMed BV® test generates a | ||
| numeric score that falls within discrete | ||
| interpretation bins based on the increasing | ||
| likelihood of bacterial infection | ||
| Results | Semi-Quantitative | Same |
| Measurand | three non-microbial (host) proteins (TRAIL, IP- | |
| 10, and CRP) | Same | |
| Conjugate | ||
| antibody | ||
| specificities | Anti-TRAIL - polyclonal antibody | |
| IP-10 – polyclonal antibody | ||
| CRP - monoclonal antibody | Same | |
| Sample type | Human serum | Same |
| Antigen | Recombinant TRAIL, IP-10 and CRP | Same |
| Measurement | ||
| System | Photomultiplier | |
| (flash chemiluminescence reader) | Photomultiplier | |
| (flash chemiluminescence reader) | ||
| Output | SCORE result | Same |
| Table of Differences | ||
| Feature | Candidate Device LIAISON® MeMed | |
| BV® | Predicate Device | |
| MeMed BV® System – K210254 | ||
| Conjugate antibody | ||
| specificities | Conjugated to an | |
| Isoluminol derivative | Conjugated to | |
| Alkaline phosphatase | ||
| Sample size | 200 μL | 100 μL |
| Assay Procedure | Automated – | |
| LIAISON® XL Analyzer | Automated – | |
| MeMed Key Analyzer | ||
| Calibration | Two levels (low and high) of | |
| calibrators for each Analyte | 3 calibrators containing high, medium and | |
| low concentration of each analyte | ||
| Calibration Interval | 3 weeks | 2 weeks |
Table 1:
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Table 2·
PERFORMANCE DATA:
CLINICAL AGREEMENT
A total of 285 serum samples from patients presenting with signs and symptoms suggestive of acute bacterial or viral infection were included in the study. Study populations included samples taken at hospital admission, Emergency Department and Urgent Care Centers. Patients ranged in age from 5 months to 92 years of age with 54.7% females (156) and 45.3% males (129).
The most common clinical syndrome was respiratory tract infections (67%) which included both upper and lower respiratory tract infections.
A primary and secondary endpoint analysis were performed to establish the diagnostic performance of the LIAISON MeMed BV test for differentiating bacterial from viral infection in patients with suspected acute bacterial or viral infection.
Primary Endpoint Analysis: The results of the LIAISON "MeMed BV" assay were compared to physician expert adjudication. Expert adjudication was used as the comparator method. Expert adjudication was determined through the process in which physicians were forced to make a bacterial, viral, or noninfectious diagnosis with categorization of patients. Panelists for each subject adjudication were drawn from a pool of 21 international experts, who were clinicians with at least 7 years of relevant clinical experience. Each panel comprised at least three experts who independently adjudicated the etiologic label for each patient. The etiologic label of the adjudicator was based on anonymized patient data. Importantly, the adjudicators were blinded to the MeMed BV result. The adjudicators were blinded to CRT and PCT results for the primary endpoint.
The performance of the LIAISON MeMed BV assay in differentiating between bacterial and viral infection /non-infection was assessed using two (2) statistical tests.
-
A Cochran-Armitage test (Agresti 2010) of the slope of a weighted linear regression of the proportion of bacterial samples in each bin and SCORE range, respectively.
-
The likelihood ratio of the bin number/SCORE range is the ratio of the proportion of all bacterial patients who fall in that bin to the proportion of nonbacterial patients who fall in that bin.
7
The analysis comprised 285 Apollo specimens characterized by expert adjudicated diagnosis, by either having a bacterial infection, or not having a bacterial infection, by having either no infection or a viral one. Each patient was also scored using the LIAISON MeMed BV assay and the predicate assay MeMed BV . The subjects were distributed in five (5) bins corresponding to the degree of suspicion for bacterial infection. The predicate device SCORE value for each was also analyzed.
A significant trend is demonstrated between the LIAISON MeMed BV SCORE and the increasing likelihood of bacterial infections across the SCORE bins. In addition, a high percentage of patients are found in the outer bins (bin 1 and 5) representing a very high likelihood of viral or bacterial infection, respectively.
| Expert Adjudication Label | |||||||
|---|---|---|---|---|---|---|---|
| LIAISON® MeMed BV® | |||||||
| SCORE BIN | N | Reference | |||||
| Bacterial | |||||||
| (N) | Reference | ||||||
| Viral or | |||||||
| Non-Infectious | |||||||
| (N) | % | ||||||
| Patients each Bin | % | ||||||
| Reference | |||||||
| Bacterial Patients | % | ||||||
| Reference | |||||||
| Viral or | |||||||
| Non-Infectious | |||||||
| Patients | Likelihood Ratio of | ||||||
| Bacterial Basis Each Bin | |||||||
| (95% CI) | |||||||
| BIN 5 | |||||||
| 90 ≤ score ≤ 100 | |||||||
| (Bacterial) | 33 | 22 | 11 | 11.6 | 66.7 | 33.3 | 13.00 |
| (7.09-25.83) | |||||||
| BIN 4 | |||||||
| 65 |