(465 days)
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No
The summary describes a standard chemiluminescence immunoassay (CLIA) technology for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond measuring relative light units (RLU) and comparing them to controls/calibrators. The performance studies focus on traditional metrics like percent agreement and reproducibility, not metrics typically associated with AI/ML model evaluation.
No.
The device is used for the qualitative detection of specific antibodies to aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome; it is a diagnostic device, not a therapeutic one.
Yes
The intended use explicitly states that the device "can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome." This directly indicates its role in assisting in diagnosis.
No
The device description clearly outlines a chemiluminescence immunoassay (CLIA) technology that utilizes magnetic particles, conjugates, and a LIAISON® Analyzer to perform the assay steps and measure light signals. This involves significant hardware components and chemical reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kits are for the "qualitative detection of specific IgG antibodies to EBV nuclear antigen synthetic peptide (EBNA) in human serum," "qualitative determination of IgM antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p-18 synthetic peptide in human serum," and "qualitative detection of specific IqG antibodies to EBV viral capsid antigen (VCA) p-18 synthetic peptide in human serum." It also states that these assays are used "as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection." This indicates that the device is intended to be used in vitro (outside the body) to examine human specimens (serum) to provide information for the diagnosis of a disease (Epstein-Barr viral Syndrome).
- Device Description: The description details the use of chemical reactions (chemiluminescence immunoassay - CLIA) to detect specific antibodies in the serum sample. This is a characteristic method used in in vitro diagnostic testing.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is where in vitro diagnostic tests are typically performed.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DiaSorin LIAISON® EBNA IgG kit uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to EBV nuclear antigen synthetic peptide (EBNA) in human serum. When performed in conjunction with other EBV marker tests, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control EBNA IgG kit is used in conjunction with LIAISON® EBNA IgG immunoassay for quality control of assay runs.
The LIAISON® EBV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p-18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control EBV IgM kit is used in conjunction with LIAISON® EBV IgM immunoassay for quality control of assay runs.
The DiaSorin LIAISON® VCA IgG kit uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IqG antibodies to EBV viral capsid antigen (VCA) p-18 synthetic peptide in human serum. When performed in conjunction with other EBV marker tests, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control VCA IgG kit is used in conjunction with LIAISON® VCA IgG immunoassay for quality control of assay runs.
Product codes (comma separated list FDA assigned to the subject device)
LLM, LSE
Device Description
The method for qualitative determination of specific IgG to EBNA is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with EBNA-1 synthetic peptide and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, EBNA antibodies present in the calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with EBNA IgG already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of EBNA IgG in calibrators, samples or controls.
The method for qualitative determination of specific IgM to Epstein-Barr viral capsid antigens (VCA) is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Chemiluminescence Analyzer. The principal components of the test are magnetic particles (solid phase) coated with p18 synthetic peptide and a conjugate of mouse monoclonal antibody to human IgM linked to an isoluminol derivative (isoluminolantibody conjugate). In the first step, samples and controls are diluted with Buffer A, which contains goat IgG to human IgG as an absorbent reagent to curb interference from human IgG specific to VCA or from rheumatoid factor. During the first incubation, VCA IgM antibodies present in the calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with VCA IgM already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured hy a photomultiplier as relative light units (RLU) and is indicative of the presence of VCA IgM in calibrators, samples or controls.
The method for qualititative determination of specific IgG to EBV viral capsid antigen (VCA) is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with EBV VCA p-18 synthetic peptide and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, VCA IgG antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with VCA IgG antibodies that are already bound to the solid phase. After each incubation, unbound material is removed Subsequently, the starter reagents are added and a flash with a wash cycle. chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of EBV VCA IgG antibodies present in calibrators, samples or controls.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
DiaSorin LIAISON® EBNA IgG
- Study Type: Comparative Clinical Trials (at two external US laboratories and at DiaSorin)
- Sample Size: 823 prospective samples (from subjects sent for EBV testing), 70 retrospective samples (VCA IgM-positive).
- Key Results (Prospective Samples vs. DiaSorin ETI-EBNA-G):
- Positive Agreement: 95.9% (632/659)
- Negative Agreement: 92.7% (152/164)
- Overall Agreement: 95.3% (784/823)
- Key Results (Prospective Samples vs. reference assays, serological classification):
- Acute infection: 100.0% (29/29) agreement
- Past infection: 98.1% (562/573) agreement
- EBV seronegative: 100.0% (62/62) agreement
- Indeterminate: 81.9% (127/155) agreement
- Overall: 95.2% (780/819) agreement
- Key Results (Retrospective Samples vs. DiaSorin ETI-EBNA-G):
- Positive Agreement: 100.0% (61/61)
- Overall Agreement: 94.3% (66/70)
- Study Type: Reproducibility
- Sample Size: 90 replicates per sample (9 frozen repository serum samples tested at 4 sites, 3 replicates per run for 10 runs).
- Overall %CV ranges: 4.35% to 24.15% (for different samples)
- Study Type: Interference
- Key Results: Assay performance not affected by hemolysis (1000 mg/dL hemoglobin), lipemia (3000 mg/dL triglycerides), and icterus (10 mg/dL bilirubin).
- Study Type: Cross-reactivity
- Sample Size: 91 samples from a disease panel (CMV IgG, VZV IgG, HSV-1 IgG, HSV-2 IgG, HHV6 IgG, Toxoplasma gondii IgG, Rubella virus IgG, ANA, RF).
- Key Results: 2 out of 91 specimens tested positive. Not conclusive evidence of interference, but possibility of cross-reactivity not excluded due to limited sample availability.
DiaSorin LIAISON® EBV IgM
- Study Type: Comparative Clinical Trials (at two external US laboratories and at DiaSorin)
- Sample Size: 819 prospective samples (from subjects sent for EBV testing), 70 retrospective samples (VCA IgM-positive).
- Key Results (Prospective Samples vs. DiaSorin ETI-EBV-M reverse ELISA Kit):
- Positive Agreement: 54.2% (58/107)
- Negative Agreement: 94.7% (674/712)
- Overall Agreement: 89.4% (732/819)
- Key Results (Prospective Samples vs. reference assays, serological classification):
- Acute infection: 100.0% (29/29) agreement
- Past infection: 95.3% (546/573) agreement
- EBV seronegative: 93.5% (58/62) agreement
- Indeterminate: 63.9% (99/155) agreement
- Overall: 89.4% (732/819) agreement
- Key Results (Retrospective Samples vs. DiaSorin ETI-EBV-M):
- Positive Agreement: 95.7% (67/70)
- Overall Agreement: 95.7% (67/70)
- Study Type: Reproducibility
- Sample Size: 90 replicates per sample (9 frozen repository serum samples tested at 3 sites, 3 replicates per run for 10 runs).
- Overall %CV ranges: 5.83% to 16.67% (for different samples, one sample based on RLU due to being below reading range).
- Study Type: Interference
- Key Results: Assay performance not affected by hemolysis (1000 mg/dL hemoglobin), lipemia (3000 mg/dL triglycerides), and icterus (20 mg/dL bilirubin).
- Study Type: Cross-reactivity
- Sample Size: 131 samples from a disease panel (CMV IgM, VZV IgM, HSV-1 IgM, HSV-2 IgM, Hepatitis A virus IgM, Hepatitis B virus (core) IgM, Toxoplasma gondii IgM, Rubella virus IgM, Rubeola virus IgM, Mumps virus IgM, RF, ANA Ig).
- Key Results: 4 out of 131 specimens tested positive. Not conclusive evidence of interference, but possibility of cross-reactivity not excluded due to limited sample availability.
DiaSorin LIAISON® VCA IgG
- Study Type: Comparative Clinical Trials (at two external US laboratories and at DiaSorin)
- Sample Size: 823 prospective samples (from subjects sent for EBV testing), 70 retrospective samples (VCA IgM-positive).
- Key Results (Prospective Samples vs. DiaSorin ETI-VCA-G ELISA Kit):
- Positive Agreement: 96.2% (717/745)
- Negative Agreement: 94.9% (74/78)
- Overall Agreement: 96.1% (791/823)
- Key Results (Prospective Samples vs. reference assays, serological classification):
- Acute infection: 82.8% (24/29) agreement
- Past infection: 98.3% (563/573) agreement
- EBV seronegative: 98.4% (61/62) agreement
- Indeterminate: 89.7% (139/155) agreement
- Overall: 96.1% (787/819) agreement
- Key Results (Retrospective Samples vs. DiaSorin ETI-VCA-G):
- Positive Agreement: 100.0% (70/70)
- Overall Agreement: 100.0% (70/70)
- Study Type: Reproducibility
- Sample Size: 90 replicates per sample (9 frozen repository serum samples tested at 3 sites, 3 replicates per run for 10 runs).
- Overall %CV ranges: 5.63% to 10.56% (for different samples).
- Study Type: Interference
- Key Results: Assay performance not affected by hemolysis (1000 mg/dL hemoglobin), lipemia (3000 mg/dL triglycerides), and icterus (20 mg/dL bilirubin).
- Study Type: Cross-reactivity
- Sample Size: 89 samples from a disease panel (CMV IgG, VZV IgG, HSV-1 IgG, HSV-2 IgG, HHV6 IgG, Toxoplasma gondii IgG, Rubella virus IgG, RF).
- Key Results: 4 out of 89 specimens tested positive. Not conclusive evidence of interference, but possibility of cross-reactivity not excluded due to limited sample availability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DiaSorin LIAISON® EBNA IgG - Prospective Samples vs. DiaSorin ETI-EBNA-G:
- Positive Agreement: 95.9% (632/659)
- Negative Agreement: 92.7% (152/164)
- Overall Agreement: 95.3% (784/823)
DiaSorin LIAISON® EBV IgM - Prospective Samples vs. DiaSorin ETI-EBV-M:
- Positive Agreement: 54.2% (58/107)
- Negative Agreement: 94.7% (674/712)
- Overall Agreement: 89.4% (732/819)
DiaSorin LIAISON® VCA IgG - Prospective Samples vs. DiaSorin ETI-VCA-G:
- Positive Agreement: 96.2% (717/745)
- Negative Agreement: 94.9% (74/78)
- Overall Agreement: 96.1% (791/823)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
DiaSorin ETI-EBNA-G Kit (K946158)
DiaSorin ETI-EBV-M reverse Kit (K946157)
DiaSorin ETI-VCA-G Kit (K946159)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).
0
| SUBMITTED BY: | David M. Ikeda
Regulatory Affairs/Quality Systems Manager
DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285
Phone (651) 351-5592
Fax (651) 351-5669
E-mail: david.ikeda@diasorin.com |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF DEVICE:
Trade Name: | DiaSorin LIAISON® EBNA IgG |
| Common Names/Descriptions: | Immunoassay for the detection of IgG antibodies to
EBV Nuclear Antigen (EBNA) |
| Classification Names: | TEST, ANTIGEN, NUCLEAR, EPSTEIN-BARR VIRUS |
| Product Code: | LLM |
| PREDICATE DEVICE: | DiaSorin ETI-EBNA-G Kit (K946158) |
6.0 510 (k) SUMMARY
DEVICE DESCRIPTION:
INTENDED USE: The DiaSorin LIAISON® EBNA IgG kit uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to EBV nuclear antigen synthetic peptide (EBNA) in human serum. When performed in conjunction with other EBV marker tests, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control EBNA IgG kit is used in conjunction with LIAISON® EBNA IgG immunoassay for quality control of assay runs.
KIT DESCRIPTION: The method for qualitative determination of specific IgG to EBNA is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with EBNA-1 synthetic peptide and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, EBNA antibodies present in the calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with EBNA IgG already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of EBNA IgG in calibrators, samples or controls.
1
PERFORMANCE DATA:
COMPARATIVE CLINICAL TRIALS: The clinical trials were conducted at two external US laboratories and at DiaSorin. Testing was performed on repository and prospective samples as defined below. The samples were tested by LIAISON® EBNA IgG and comparison assay, at the trial sites per the manufacturers' instructions for use.
| Prospective Samples: Subjects Sent to the Laboratory for EBV Testing: | |||||
|---|---|---|---|---|---|
| ----------------------------------------------------------------------- | -- | -- | -- | -- | -- |
| LIAISON®
EBNA IgG | DiaSorin ETI-EBNA-G | | | | Percent Agreement | | Exact 95%
confidence interval | |
|--------------------------------|---------------------|----------|-------|----------|-------------------|-----------|----------------------------------|--|
| | Positive | Negative | Total | Positive | 95.9% | (632/659) | 94.1 - 97.3% | |
| Positive (≥22.0 U/mL) | 632 | 9 | 641 | Negative | 92.7% | (152/164) | 87.6 - 96.2% | |
| Equivocal (18.0-
21.9 U/mL) | 2 | 3 | 5 | Overall | 95.3% | (784/823) | 93.6 - 96.6% | |
| Negative (