(245 days)
Focus Diagnostics' Plexus™ EBV IgM Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis.
The performance of this assay has not been established for use in the diagnosis of nasopharyngeal carcinoma and Burkitt's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.
Multiplexed Immunoassay for the Qualitative Detection of Human IgM Antibodies to Epstein-Barr Virus
The Focus Diagnostics Plexus™ EBV IgM uses an Antigen Bead suspension that contains two distinct EBV antigen bead types (VCA and Heterophile) and one process control bead type that fluoresce at different wavelengths and/or intensities.
The Focus Diagnostics Plexus™ EBV IgM is a three step procedure.
- Patient sera are diluted, and the diluted sera are incubated with Antigen Beads. If EBV antibodies are present, then the antibodies bind to the corresponding antigen beads.
- Phycoerythrin-conjugated goat Anti-human IgM (Conjugate) is added, binds to the bound EBV antibody (if present), and forms a Conjugate-EBV antibody-antigen bead sandwich.
- Fluorescence from each distinct EBV antigen bead type is measured and compared against a Cutoff Calibrator.
Plexus EBV IgM Multi-Analyte Diagnostics Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a table format with pre-defined thresholds. Instead, it presents performance data (positive and negative percent agreements) against predicate devices and then justifies substantial equivalence. Based on the comparative studies, the implicit acceptance criteria are that the device's performance should be comparable to or better than the FDA-cleared predicate devices.
| Metric (Implicit Acceptance Criteria: Comparable to Predicate) | VCA IgM Performance (Plexus vs. Consensus Predicate) | Heterophile IgM Performance (Plexus vs. Predicate Rapid Test) |
|---|---|---|
| Prospective Samples (N=723) | ||
| Positive Percent Agreement | 85.9% (95% CI: 77.3-91.6%) | 80% (95% CI: 69.6-87.5%) |
| Negative Percent Agreement | 97.8% (95% CI: 96.3-98.7%) | 98.9% (95% CI: 97.8-99.5%) |
| Retrospective Samples (N=150) | ||
| Positive Percent Agreement | 97.2% (95% CI: 93.1-98.9%) | 87.5% (95% CI: 80.1-92.4%) |
| Negative Percent Agreement | 33.3% (95% CI: 9.7-70.0%) (Note: Low N for negative predicate in retrospective VCA IgM) | 92.1% (95% CI: 79.2-97.3%) |
| Reproducibility (Implicit Acceptance Criteria: Low %CV) | ||
| Inter-laboratory %CV (VCA IgM) | 6.7% to 51.8% (across samples) | 1.9% to 47.8% (across samples) |
| Intra-assay & Inter-assay %CV (VCA IgM) | 2.2% to 46.8% (across samples) | 3.0% to 47.2% (across samples) |
| Inter-lot %CV (VCA IgM) | 5.0% to 24.4% (across samples) | 3.8% to 37.9% (across samples) |
| Cross-Reactivity (Implicit Acceptance Criteria: Minimal cross-reactivity) | ||
| Cross-reactives with discrepancies | ANA (22 discrepancies for VCA IgM), CMV (5 discrepancies for VCA IgM, 1 discrepancy for Heterophile), Rheumatoid Factor (4 discrepancies for VCA IgM), VZV (3 discrepancies for VCA IgM) | |
| Interference (Implicit Acceptance Criteria: No significant interference) | No interference observed for triglycerides, albumin, bilirubin, and hemoglobin. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Prospective Samples: 723 samples (723 for VCA IgM, 723 for Heterophile IgM)
- Retrospective Samples: 150 samples (150 for VCA IgM, 150 for Heterophile IgM)
- Data Provenance: The studies were conducted at three United States testing sites: a hospital laboratory located in the Northeast, a pediatric hospital laboratory located in the Mid-West, and Focus Diagnostics. Samples included both prospective (n=723) and retrospective (n=150) specimens. The samples were sequentially submitted to the laboratory, archived, and masked.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of individual experts or their qualifications who directly established the "ground truth" for the test set. Instead, it refers to "consensus predicate" and "predicate rapid test."
For VCA IgM, the ground truth was established by a "consensus predicate" involving a combination of:
* A FDA-cleared commercially available ELISA
* A FDA-cleared commercially available immunofluorescent (IFA) test
* A FDA-cleared commercially available flow cytometry-based immunoassay.
For Heterophile IgM, the ground truth was established against a "FDA cleared heterophile rapid test."
The qualifications of the individuals who performed these predicate tests are not specified but would typically be trained laboratory personnel.
4. Adjudication Method for the Test Set
- VCA IgM: A "consensus based algorithm (2/3)" was used to determine the predicate result for comparison with the Plexus VCA IgM result. This means that at least two out of the three predicate devices had to agree on the result (positive or negative) for a consensus to be reached.
- Heterophile IgM: The document states that the Plexus EBV Heterophile IgM analyte was tested against a "FDA cleared heterophile rapid test," implying a direct comparison rather than a consensus among multiple predicates for this analyte.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study compares the device's performance directly against predicate devices, not human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was done. The entire study focuses on the performance of the Plexus EBV IgM Multi-Analyte Diagnostics device (algorithm only, as it is an in vitro diagnostic assay) against predicate devices without human interpretation as part of its core function, other than potentially reading the results of the predicate devices.
7. Type of Ground Truth Used
The ground truth used was based on comparison with predicate devices, which are themselves FDA-cleared diagnostic assays.
- For VCA IgM, it was a "consensus predicate" combining results from an ELISA, IFA, and flow cytometry-based immunoassay.
- For Heterophile IgM, it was a "FDA cleared heterophile rapid test."
Additionally, a "Typical Antibody Response Classification" table (Plexus EBV Serological Status) outlines an algorithm for classifying EBV infection status using various serological markers, including VCA IgM and Heterophile Antibody. This table serves as a reference for interpreting the combined results in the context of disease diagnosis.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. The performance studies described involve prospective and retrospective samples used for comparison with predicate devices. This suggests a validation study rather than a development and training paradigm typical of machine learning algorithms that require distinct training sets. Since this is an immunoassay, the "training" would be tied to the assay's development and optimization, not a separate dataset for an algorithm.
9. How the Ground Truth for the Training Set was Established
As no explicit training set is mentioned in the context of algorithm development, the method for establishing ground truth for a training set is not applicable or detailed in the provided document. The performance evaluation relies on comparing the device's results against established FDA-cleared predicate methods.
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510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 1 of 13
| Applicant | Focus Diagnostics, Inc.10703 Progress WayCypress, California 90630USA | |
|---|---|---|
| Establishment Registration No. | 2023365 | AUG - 4 2008 |
| Contact Person | Constance Bridgestel 714.220.1900fax 714.995.6921cbridges@focusdx.com | |
| Summary Date | June 27, 2008 | |
| Proprietary Name | Plexus EBV IgM Multi-Analyte Diagnostics | |
| Generic Name | Epstein-Barr Virus Serological Assays | |
| Classification | Class I | |
| Predicate Devices | Osom® Mono TestDiamedix EBV VCA IgM ELISAAthena Multi-Lyte EBV VCA IgM Test System |
Device Description
Multiplexed Immunoassay for the Qualitative Detection of Human IgM Antibodies to Epstein-Barr Virus
Intended Use
Focus Diagnostics' Plexus™ EBV IgM Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis.
Epstein-Barr Virus VCA (IgM) Recomb Immun Antibod
The performance of this assay has not been cstablished for use in the diagnosis of nasopharyngeal carcinoma and Burkit's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.
The Focus Diagnostics Plexus™ EBV IgM uses an Antigen Bead suspension that contains two distinct EBV antigen bead types (VCA and Heterophile) and one process control bead type that fluoresce at different wavelengths and/or intensities.
The Focus Diagnostics Plexus™ EBV IgM is a three step procedure.
-
- Patient sera are diluted, and the diluted sera are incubated with Antigen Beads. If EBV antibodies are present, then the antibodies bind to the corresponding antigen beads.
-
- Phycoerythrin-conjugated goat Anti-human IgM (Conjugate) is added, binds to the bound EBV antibody (if present), and forms a Conjugate-EBV antibody-antigen bead sandwich.
-
- Fluorescence from each distinct EBV antigen bead type is measured and compared against a Cutoff Calibrator.
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Image /page/1/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in a bold, sans-serif font, with a curved graphic element above and to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. The overall design is simple and professional.
510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 2 of 13
Comparison with Predicate Devices: VCA IgM analyte:
| Item | Device | Predicates | ||
|---|---|---|---|---|
| Name | Plexus™ EBV IgMMulti-AnalyteDiagnostics | Diamedix VCA IgM,ELISA | Athena Multi-LyteEBV VCA IgM TestSystem | Epstein-Barr VirusVCA (IgM) RecombImmun Antibod(IFA) |
| Similarities between Device and Predicate | ||||
| Intended use | Focus Diagnostics'Plexus™ EBV (VCA)IgM Multi-AnalyteDiagnostics test kit isintended forqualitatively detectingthe presence or absenceof human IgM classantibodies to viral capsidantigen (VCA), andheterophile antibodies inhuman sera. The test isindicated as an aid in thediagnosis of EBVinfection and EBV-associated infectiousmononucleosis. | Diamedix Corp EBVVCA IgM ELISA isintended for thequalitative and semi-quantitative determinationof IgM antibodies toEpstein-Barr Virus(recombinant) viral capsidantigen (EBV-VCA IgM)in human serum byindirect enzymeimmunoassay. The Is-EBV-VCA IgM test kitmay be used incombination with otherEpstein-Barr serologies,Viral Capsid Antigen(VCA) IgG, Epstein-BarrNuclear Antigen-1(EBNA-1) IgG and IgM,Early Antigen-Diffuse(EA-D) IgG and IgM andheterophile antibody, asan aid in the diagnosis ofinfectious mononucleosis(IM). | The Zeus Scientific,Inc. AtheNA Multi-Lyte® EBV VCAIgM Test System is amicroparticle-basedimmunoassayintended for thequalitative detectionof IgM class antibodyto Epstein-Barr virus,viral capsid antigen inhuman serum. Thetest system isintended to be usedfor the laboratorydiagnosis of EBV-associated infectiousmononucleosis andprovidesepidemiologicalinformation on thediseases caused byEpstein-Barr virus. | Focus Diagnostics'Epstein-Barr VirusViral Capsid Antigens(EBV VCA) IgGImmunofluorescenceAntibody (IFA) test isintended for thedetection and semi-quantitation of humanIgG antibodies to theviral capsid antigens(VCA) of Epstein-Barrvirus in human serumas an aid in the clinicaldiagnosis of infectiousmononucleosis. |
| Indications for use | The test is indicated asan aid in the diagnosis ofEBV infection andEBV-associatedinfectiousmononucleosis. | The device is indicated foruse with patients with thesigns and symptoms ofinfectious mononucleosis. | The device isindicated forlaboratory diagnosisof EBV-associatedinfectiousmononucleosis and toprovideepidemiologicalinformation on thediseases caused byEpstein-Barr virus | The test is indicated asan aid in the clinicaldiagnosis of infectiousmononucleosis. |
| ImmunoglobulinType | IgM | IgM | IgM | IgM |
| Sample matrix | Serum | Serum | Serum | Serum |
| CLIA complexity | High | High | High | High |
| Difference between Device and Predicate | ||||
| Antigen | EBV-VCA: VCA gp125, affinity purified | EBV-VCA: Recombinant47 kDa fusion half of p18 | EBV VCA pg125 | Recombinant VCAantigen (rVCA) |
| Item | Device | Predicates | ||
| Name | Plexus™ EBV IgMMulti-AnalyteDiagnostics | Diamedix VCA IgM,ELISA | Athena Multi-LyteEBV VCA IgM TestSystem | Epstein-Barr VirusVCA (IgM) RecombImmun Antibod(IFA) |
| antigen | ||||
| Strain | N/A- purified protein | N/A- Recombinant protein | N/A native protein | N/A- Recombinantprotein |
| Host Cell Line | EBV-VCA: Native(P3H3 or P3HR-1) | EBV-VCA: E. coli(unknown) | Unknown | Mammalian cell line |
| Methodology | Multiplex MicrobeadImmunoassay (MMIA)based on Luminex XMAPtechnology | Enzyme Immunoassaytechnology. | Flow cytometryimmunoassay | IndirectImmunofluorescenceAntibody Test |
| Interpretation oftest results | Perform automatedcalculations usingPlexus software. | Manual calculation | AtheNA Multi-Lyteinstrument | Manual |
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Image /page/2/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, uppercase letters. A curved, swooping line extends from the left side of the "F", arcing over the word. Below "FOCUS" is the word "Diagnostics" in a smaller, less bold font, underlined with a thin line.
510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008
Page 3 of 13
Comparison with Predicate Devices: Heterophile IgM analyte:
| Item | Device | Predicate |
|---|---|---|
| Name | Plexus™ EBV IgM Multi-AnalyteDiagnostics | Osom® Mono Test, Heterophile |
| Similarity between Device and Predicate | ||
| Intended use | Focus Diagnostics' Plexus™ EBV(Heterophile) IgM Multi-Analyte Diagnosticstest kit is intended for qualitatively detectingthe presence or absence of human IgM classantibodies to viral capsid antigen (VCA), andheterophile antibodies in human sera. The testis indicated as an aid in the diagnosis of EBVinfection and EBV-associated infectiousmononucleosis. | The OSOM Mono Test is intended for the quantitativedetection infectious mononucleosis heterophileantibodies in serum, plasma and whole blood as an aidin the diagnosis of infectious mononucleosis. |
| Indications for use | The test is indicated as an aid in the diagnosisof EBV infection and EBV-associatedinfectious mononucleosis. | Intended to make a serological diagnosis of EBVinfections |
| ImmunoglobulinType | IgM | IgM |
| Difference between Device and Predicate | ||
| Sample matrix | Serum | Serum / Plasma / Whole Blood |
| CLIA complexity | High | Moderate |
| Methodology | Multiplex Microbead Immunoassay (MMIA)based on Luminex XMAP technology. | Immunocheomatorgraphic Test |
:
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Image /page/3/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with a curved graphic element above and to the left of the word. Below the word "FOCUS" is the word "Diagnostics" in a smaller, less bold font, underlined by a thin line. The overall design is simple and professional.
510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M
Prepared Date: July 22, 2008
Page 4 of 13
| Item | Device | Predicate |
|---|---|---|
| Name | Plexus™ EBV IgM Multi-AnalyteDiagnostics | Osom® Mono Test, Heterophile |
| Strain | NA purified protein | NA native protein |
| Host Cell Line | Purified from bovine red blood cells | Extract of bovine erythrocytes |
| Antigen | Heterophile: purified protein | Heterophile: native protein |
| Interpretation oftest results | Perform automated calculations using Plexussoftware. | Visual evaluation |
EXPECTED VALUES
Outside investigators assessed the device with prospective masked sequential samples that were submitted for routine EBV testing (n=723.) The prevalence of EBV will vary depending on age, geographic location, testing method used, and other factors. The comparator assay was performed by indirect enzyme immunoassay used in combination with other Spstein-Barr serologies (VCA) IgG and IgM, Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG, Early Antigen-Diffuse (EA-D) IgG and a heterophile rapid antibody test. The observed prevalence is in Table 1. Expected values are presented by age and gender in the tables below for serum sample from a Total Population (N= 723). For all analytes, index values of <0.90 are negative, 20.90 to ≤ 1.10 are equivocal and > 1.10 are positives.
| Table 1: Observed Prevalence – EBV Plexus | ||
|---|---|---|
| VCA IgM | Heterophile | |
| Positive | 12.7% (92/723) | 9.3% (67/723) |
| Equivocal | 0.6% (4/723) | 0% (0/723) |
| Negative | 86.7% (627/723) | 90.7% (656/723) |
| Table 2: EBV Plexus Results VCA IgM | ||||||||
|---|---|---|---|---|---|---|---|---|
| Positive | Equivocal | Negative | ||||||
| Age | Gender | n | % | n | % | n | % | Total |
| <5 | F | 1 | 6.7 | 0 | 0 | 14 | 93.3 | 15 |
| <5 | M | 2 | 5.6 | 0 | 0 | 34 | 94.4 | 36 |
| 5-12 | F | 10 | 10 | 2 | 2 | 88 | 88 | 100 |
| 5-12 | M | 6 | 6.3 | 0 | 0 | 89 | 93.7 | 95 |
| 13-20 | F | 28 | 16.8 | 0 | 0 | 139 | 83.2 | 167 |
| 13-20 | M | 24 | 18.5 | 1 | 0.8 | 105 | 80.8 | 130 |
| 21-30 | F | 7 | 18.4 | 0 | 0 | 31 | 81.6 | 38 |
| 21-30 | M | 5 | 27.8 | 0 | 0 | 13 | 72.2 | 18 |
| 31-40 | F | 1 | 6.3 | 0 | 0 | 15 | 93.8 | 16 |
| 31-40 | M | 1 | 7.1 | 0 | 0 | 13 | 92.9 | 14 |
| 41-50 | F | 3 | 15.8 | 0 | 0 | 16 | 84.2 | 19 |
| 41-50 | M | 1 | 7.7 | 0 | 0 | 12 | 92.3 | 13 |
| 51-60 | F | 1 | 6.3 | 1 | 6.3 | 14 | 87.5 | 16 |
| 51-60 | M | 0 | 0 | 0 | 0 | 11 | 100 | 11 |
| 61-70 | F | 0 | 0 | 0 | 0 | 9 | 100 | 9 |
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Image /page/4/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, black shape is positioned to the left of the word "FOCUS", creating a visual element that complements the text.
510(k) Summary of Safety and Effectiveness Piexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 5 of 13
| Table 2: EBV Plexus Results VCA IgM | ||||||||
|---|---|---|---|---|---|---|---|---|
| Age | Gender | n | % | n | % | n | % | Total |
| 61-70 | M | 1 | 10 | 0 | 0 | 9 | 90 | 10 |
| >70 | F | 0 | 0 | 0 | 0 | 7 | 100 | 7 |
| >70 | M | 1 | 11.1 | 0 | 0 | 8 | 88.9 | 9 |
| Total | 92 | 12.7 | 4 | 0.6 | 627 | 86.7 | 723 |
| Table 3: EBV Plexus Results Heterophile IgM | ||||||||
|---|---|---|---|---|---|---|---|---|
| Age | Gender | Positive | Equivocal | Negative | Total | |||
| n | % | n | % | n | % | |||
| <5 | F | 0 | 0 | 0 | 0 | 15 | 100 | 15 |
| <5 | M | 2 | 5.6 | 0 | 0 | 34 | 94.4 | 36 |
| 5-12 | F | 5 | 5 | 0 | 0 | 95 | 95 | 100 |
| 5-12 | M | 4 | 4.2 | 0 | 0 | 91 | 95.8 | 95 |
| 13-20 | F | 21 | 12.6 | 0 | 0 | 146 | 87.4 | 167 |
| 13-20 | M | 24 | 18.5 | 0 | 0 | 106 | 81.5 | 130 |
| 21-30 | F | 5 | 13.2 | 0 | 0 | 33 | 86.8 | 38 |
| 21-30 | M | 5 | 27.8 | 0 | 0 | 13 | 72.2 | 18 |
| 31-40 | F | 1 | 6.3 | 0 | 0 | 15 | 93.8 | 16 |
| 31-40 | M | 0 | 0 | 0 | 0 | 14 | 100 | 14 |
| 41-50 | F | 0 | 0 | 0 | 0 | 19 | 100 | 19 |
| 41-50 | M | 0 | 0 | 0 | 0 | 13 | 100 | 13 |
| 51-60 | F | 0 | 0 | 0 | 0 | 16 | 100 | 16 |
| 51-60 | M | 0 | 0 | 0 | 0 | 11 | 100 | 11 |
| 61-70 | F | 0 | 0 | 0 | 0 | 9 | 100 | 9 |
| 61-70 | M | 0 | 0 | 0 | 0 | 10 | 100 | 10 |
| >70 | F | 0 | 0 | 0 | 0 | 7 | 100 | 7 |
| >70 | M | 0 | 0 | 0 | 0 | 9 | 100 | 9 |
| Total | 67 | 9.3 | 0 | 0 | 656 | 90.7 | 723 |
The table below summarizes the breakdown of the samples age and gender information. The distribution chart below exhibits the age distribution of all 873 samples included in the study.
| Age Information: | |||
|---|---|---|---|
| Summary of Female Subjects | Summary of Male Subjects | ||
| n | 474 | n | 399 |
| mean | 20.0 | mean | 18.3 |
| median | 16.0 | median | 14.0 |
| min | 1 | min | 1 |
| max | 88 | max | 87 |
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Image /page/5/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font. Above and to the left of the word is a curved, swooping shape. Below the word "FOCUS" is the word "Diagnostics" in a smaller, less bold font, underlined with a thin line.
510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 6 of 13
Image /page/5/Figure/3 description: The image is a bar graph titled "Distribution of Patient Age". The x-axis is labeled "Age" and shows age ranges from 1-5 to 85-90. The y-axis is labeled "Frequency" and ranges from 0 to 300. The bar graph shows that the highest frequency of patients is in the 16-20 age range, with a frequency of approximately 240.
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Image /page/6/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font with a line above it. To the left of the word "FOCUS" is a curved, black shape that resembles a crescent.
510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008
Page 7 of 13
PERFORMANCE CHARACTERISTICS
Typical Antibody Response Classification
The table below summarizes a generally accepted algoritum for classifying the EBV infection status via EBV serologic profiles.
| EBV SerologicalStatus | EBNA-1 IgG | EBV VCA IgG | EBV EA-D IgG | EBV VCA IgM | HeterophileAntibody | |||
|---|---|---|---|---|---|---|---|---|
| Negative | Negative | Negative | Positive | Negative | ||||
| Negative | Negative | Negative | Positive | Positive | ||||
| Negative | Positive | Negative | Positive | Positive | ||||
| Primary | Negative | Negative | Positive | Positive | Negative | |||
| Acute | Negative | Negative | Positive | Positive | Positive | |||
| Negative | Positive | Positive | Positive | Negative | ||||
| Acute | Negative | Positive | Positive | Positive | Positive | |||
| Negative | Positive | Positive | Negative | Positive | ||||
| LateAcute | Positive | Positive | Positive | Negative | Negative | |||
| Positive | Positive | Positive | Positive | Positive | ||||
| Positive | Positive | Positive | Positive | Negative | ||||
| Positive | Positive | Negative | Positive | Positive | ||||
| Positive | Positive | Negative | Positive | Negative | ||||
| Negative | Positive | Negative | Positive | Negative | ||||
| Recovering | Negative | Positive | Positive | Negative | Negative | |||
| Past Infection | Negative | Positive | Negative | Negative | Negative | |||
| Positive | Positive | Negative | Negative | Negative | ||||
| No Infection | Negative | Negative | Negative | Negative | Negative | |||
| Indeterminant | Combinations not listed above (n =18) |
Comparison Studies
Performance of the Plexus EBV VCA IgM analyte was tested against a combination (hereafter referred to as 'consensus predicate') of a FDA-cleared commercially available ELISA, a FDA cleared commercially available immunofluroscent (IFA) test and a FDA cleared commercially available flow cytomcery based immunoassay. For each sample, a consensus based algorithm (2/3) was used to determine the predicate result for comparison with the Plexus VCA IgM result. The Plexus EBV Heterophile IgM analyte was tested against a FDA cleared heterophile rapid test. The studies were conducted at three United States testing sites: a hospital laboratory located in Northeast. a pediatric hospital laboratory located in the Mid-West, and Focus with serum samples in which EBV tests were ordered. The sera were sequentially submitted to the laboratory, archived, and masked, Samples were collected at three sites and include both prospective (n = 723) and retrospective (n = 150) specimens. The Plexus EBV IgM tests were run in conjunction with the Plexus EBV IgG tests for a complete antibody profile. The samples were then classified into EBV infection status using the Serological Status table above.
Prospective Population Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte (N = 723) Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249) and Focus (n=124).
The following table outlines the positive and negative percent agreements for prospective samples for VCA IgM analyte when the consensus predicate is used for VCA IgM analysis.
| Table 4: EBV VCA IgM Results | |||||
|---|---|---|---|---|---|
| Consensus Predicate | n | Positive | Equivocal | Negative | % Agreement |
| Positive | 88 | 79 | 3 | 6 | 85.9%(79/92), 95% CI:77.3-91.6% |
| Negative | 630 | 12 | 1 | 617 | 97.8%(617/631), 95% CI:96. 3-98.7% |
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Image /page/7/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in large, bold, sans-serif font. Below the word "FOCUS" is a horizontal line, and below the line is the word "Diagnostics" in a smaller, sans-serif font. To the left of the word "FOCUS" is a curved, crescent-shaped graphic element.
510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M
Prepared Date: July 22, 2008
Page 8 of 13
| Table 4: EBV VCA IgM Results | |||||
|---|---|---|---|---|---|
| Consensus Predicate | n | Plexus | |||
| Positive | Equivocal | Negative | % Agreement | ||
| No consensus1 | 5 | 1 | 0 | 4 | NA |
1 No consensus results: the combination of three predicates could not yield a conclusive result for these samples – a 2/3 majority could not be obtained
Prospective Population Samples: Plexus EBV vs. Heterophile Rapid Test for Heterophile IgM analyte (N = 723) Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249) and Focus (n=124).
The following table outlines the positive percent agreements for prospective samples for Heterophile IgM analyte when the Heterophile rapid test is used as predicate for Heterophile IgM analysis and consensus predicate is used for VCA IgM analysis.
| Table 5: EBV Heterophile Results | |||||
|---|---|---|---|---|---|
| Predicate Rapid Test | n | Positive | Equivocal | Negative | % Agreement |
| Positive | 75 | 60 | 0 | 15 | 80%(60/75), 95% CI:69.6-87.5% |
| Equivocal | 0 | 0 | 0 | 0 | N/A |
| Negative | 648 | 7 | 0 | 641 | 98.9%(641/648), 95% CI:97.8-99.5% |
Prospective Population Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte (by Serological Status) (N = 723)
Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249) and Focus (n=124).
The following table outlines the positive percent agreements across various serological classifications for prospective samples for VCA IgM analyte when the consensus predicate is used for VCA IgM analysis.
| Table 6: EBV VCA IgM Results | ||||||
|---|---|---|---|---|---|---|
| Serostatus by Predicates | Consensus Predicate | n | Plexus | % Agreement | ||
| Positive | Equivocal | Negative | ||||
| Acute | Positive | 59 | 56 | 2 | 1 | 94.9%(56/59), 95% CI:86.1-98.3% |
| Negative | 1 | 0 | 0 | 1 | 100%(1/1), 95% CI:20.7-100% | |
| No consensus | 0 | 0 | 0 | 0 | NA | |
| Acute | Positive | 14 | 9 | 1 | 4 | 64.3%(9/14), 95% CI:38.8-83.7% |
| Negative | 58 | 2 | 0 | 56 | 96.6%(56/58), 95% CI:88.3-99% | |
| No consensus | 0 | 0 | 0 | 0 | NA | |
| Recovering | Positive | 0 | 0 | 0 | 0 | NA |
| Recovering | Negative | 1 | 0 | 0 | 1 | 100%(1/1), 95% CI:20.7-100% |
| Recovering | No consensus | 0 | 0 | 0 | 0 | NA |
| Previous Infection | Positive | 1 | 0 | 0 | 1 | 0%(0/1), 95% CI:0-79.3% |
| Previous Infection | Negative | 296 | 9 | 1 | 286 | 96.3%(286/297), 95% CI:93.5-97.9% |
| Previous Infection | No consensus1 | 1 | 1 | 0 | 0 | NA |
| No Infection | Positive | 1 | 1 | 0 | 0 | 50%(1/2), 95% CI:9.5-90.5% |
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved graphic element above and to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. The overall design is simple and professional.
510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008
Page 9 of 13
| Table 6: EBV VCA IgM Results | ||||||
|---|---|---|---|---|---|---|
| Consensus Predicate | Plexus | |||||
| Serostatus byPredicates | n | Positive | Equivocal | Negative | % Agreement | |
| No Infection | Negative | 225 | 0 | 0 | 225 | 100%(225/225), 95% CI:98.3-100% |
| No Infection | No consensus1 | 1 | 0 | 0 | 1 | NA |
| Indeterminate | Positive | 13 | 13 | 0 | 0 | 81.3%(13/16), 95% CI:57.0-93.4% |
| Indeterminate | Negative | 49 | 1 | 0 | 48 | 98%(48/49), 95% CI:89.3-99.6% |
| Indeterminate | No consensus1 | 3 | 0 | 0 | 3 | NA |
1 No consensus results: the combination of three predicates could not yied a conclusive result for these sumples - a 2/3 majority could not he obtained.
Prospective Population Samples: Plexus EBV vs. Heterophile IgM analyte (by Serological Status) (N = 723)
Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249), and Focus (n=124).
The following table outlines the positive percent agreements across various scrological classifications for prospective samples for Heterophile IgM analyte when the Heterophile rapid test is used as predicate for Heterophile IgM analysis and consensus predicate is used for VCA IgM analysis.
| Predicate HeterophileRapid Test | Plexus | Table 7: EBV Heterophile IgM Results | |||||
|---|---|---|---|---|---|---|---|
| Serological Status byPredicates | Primary Acute | n | Positive | Equivocal | Negative | % Agreement | |
| Positive | 51 | 48 | 0 | 3 | 94.1%(48/51), 95% CI:84.1-98% | ||
| PrimaryAcute | Equivocal | 0 | 0 | 0 | 0 | NA | |
| Negative | 9 | 1 | 0 | 8 | 88.9%(8/9), 95% CI:56.5-98% | ||
| Acute | Positive | 5 | 2 | 0 | 3 | 40%(2/5), 95% CI:11.8-76.9% | |
| LateAcute | Equivocal | 0 | 0 | 0 | 0 | NA | |
| Negative | 67 | 1 | 0 | 66 | 98.5%(66/67), 95% CI:92-99.7% | ||
| Recovering | Positive | 0 | 0 | 0 | 0 | NA | |
| Equivocal | 0 | 0 | 0 | 0 | NA | ||
| Negative | 1 | 0 | 0 | 1 | 100%(1/1), 95% CI:20.7-100% | ||
| Previous Infection | Positive | 0 | 0 | 0 | 0 | NA | |
| Equivocal | 0 | 0 | 0 | 0 | NA | ||
| Negative | 298 | 2 | 0 | 296 | 99.3%(296/298), 95% CI:97.6-99.8% | ||
| No Infection | Positive | 0 | 0 | 0 | 0 | NA | |
| Equivocal | 0 | 0 | 0 | 0 | NA | ||
| Negative | 227 | 3 | 0 | 224 | 98.7%(224/227), 95% CI:96.2-99.5% | ||
| Positive | 19 | 10 | 0 | 9 | 52.6%(10/19), 95% CI:31.7-72.7% | ||
| Indeterminate | Equivocal | 0 | 0 | 0 | 0 | NA | |
| Negative | 46 | 0 | 0 | 46 | 100%(46/46), 95% CI:92.3-100% |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, black shape is positioned to the left of the word "FOCUS", resembling a stylized check mark or swoosh. A horizontal line separates the word "FOCUS" from the word "Diagnostics".
K073381 510(k) Summary of Safety and Effectiveness
Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 10 of 13
Presumed Acute Retrospective Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte Samples were collected and tested by Mid-West investigator (n=150).
The following table outlines the positive and negative percent agreements for retrospective samples for VCA IgM analyte when the consensus predicate is used for VCA IgM analysis.
| Consensus Predicate | n | Plexus | % Agreement | ||
|---|---|---|---|---|---|
| Positive | Equivocal | Negative | |||
| Positive | 143 | 140 | 0 | 3 | 97.2%(140/144), 95% CI:93.1-98.9% |
| Negative | 5 | 3 | 0 | 2 | 33.3%(2/6), 95% CI:9.7-70.0% |
| No consensus1 | 2 | 1 | 0 | 1 | NA |
1 No consensus results: the combination of three predicates could not yield a conclusive result for these samples - a 2/3 majority could not be obtained.
Presumed Acute Retrospective Samples: Plexus EBV vs. Heterophile Rapid Test for Heterophile IgM analyte Samples were collected and tested by Mid-West investigator (n=150).
The following table outlines the positive and negative percents for retrospective samples for Heterophile IgM analyte when the Heterophile rapid test is used as predicate for Heterophile IgM analysis and consemasus predicate is used for VCA IgM analysis.
| Table 8: EBV Heterophile Results | |||||
|---|---|---|---|---|---|
| Predicate Rapid Test | n | Plexus | % Agreement | ||
| Positive | Equivocal | Negative | |||
| Positive | 112 | 98 | 3 | 11 | 87.5%(98/112), 95% CI:80.1-92.4% |
| Negative | 38 | 3 | 0 | 35 | 92.1%(35/38), 95% CI:79.2-97.3% |
Presumed Acute Retrospective Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte (by Serological Status)
Samples were collected and tested by Mid-West investigator (n=150).
The following table outlines the positive percent agreements across various scrological classifications for retrospective samples for VCA IgM analyte when the consensus predicate is used for VCA IgM analysis,
| Table 9: EBV VCA IgM Results | ||||||||
|---|---|---|---|---|---|---|---|---|
| Serological Status byPredicates | Consensus Predicate | n | Plexus | % Agreement | ||||
| Positive | Equivocal | Negative | ||||||
| Acute | PrimaryAcute | Positive | 104 | 103 | 0 | 1 | 99%(103/104), 95% CI:94.8-99.8% | |
| Negative | 1 | 0 | 0 | 1 | 50%(1/2), 95% CI:9.5-90.5% | |||
| No consensus1 | 1 | 1 | 0 | 0 | NA | |||
| Acute | LateAcute | Positive | 8 | 7 | 0 | 1 | 87.5%(7/8), 95% CI:52.9-97.8% | |
| Negative | 0 | 0 | 0 | 0 | NA | |||
| No consensus | 0 | 0 | 0 | 0 | NA | |||
| No Infection | Positive | 0 | 0 | 0 | 0 | NA | ||
| No Infection | Negative | 2 | 1 | 0 | 1 | 50%(1/2), 95% CI:9.5-90.5% | ||
| No Infection | No consensus | 0 | 0 | 0 | 0 | NA | ||
| Indeterminate | Positive | 31 | 30 | 0 | 1 | 93.8%(30/32), 95% CI:79.9-98.3% |
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in large, bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, black shape is positioned to the left of the word "FOCUS", creating a visual element that complements the text.
510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 11 of 13
| Table 9: EBV VCA IgM Results | ||||||
|---|---|---|---|---|---|---|
| Serological Status byPredicates | Consensus Predicate | n | Positive | Equivocal | Negative | % Agreement |
| Indeterminate | Negative | 2 | 2 | 0 | 0 | 0%(0/2), 95% CI:0-65.8% |
| Indeterminate | No consensus1 | 1 | 0 | 0 | 1 | NA |
4 No consensus results: the contination of three predicates could not yield a conclusive result for these samples - a 2/3 majority could not be obtained.
Presumed Acute Retrospective Samples Plexus EBV vs. Heterophile Rapid Test for Heterophile IgM analyte (by Serological Status)
Samples were collected and tested by Mid-West investigator (n=150).
The following table outlines the positive percent agreements across various serological classifications for retrospective samples for Heterophile IgM analyte when the Heterophile rapid test is used as predicate for Heterophile IgM analysis and consensus predicate is used for VCA IgM analysis.
| Table 10: EBV Heterophile IgM Results | |||||||
|---|---|---|---|---|---|---|---|
| Predicate HeterophileRapid Test | Plexus | ||||||
| Serological Status byPredicates | n | Positive | Equivocal | Negative | % Agreement | ||
| Acute | PrimaryAcute | Positive | 87 | 75 | 2 | 10 | 86.2%(75/87), 95% CI:77.4-91.9% |
| Negative | 19 | 2 | 0 | 17 | 89.5%(17/19), 95% CI:68.6-97.1% | ||
| Acute | LateAcute | Positive | 3 | 2 | 0 | 1 | 66.7%(2/3), 95% CI:20.8-93.9% |
| Negative | 5 | 0 | 0 | 5 | 100%(5/5), 95% CI:56.6-100% | ||
| No Infection | Positive | 0 | 0 | 0 | 0 | NA | |
| No Infection | Negative | 2 | 0 | 0 | 2 | 100%(2/2), 95% CI:34.2-100% | |
| Indeterminate | Positive | 22 | 21 | 1 | 0 | 95.5%(21/22), 95% CI:78.2-99.2% | |
| Indeterminate | Negative | 12 | 1 | 0 | 11 | 91.7%(11/12), 95% CI:64.6-98.5% |
Inter-laboratory, Intra-assay and Inter-assay Reproducibility
The interfintra-assay reproducibility and the inter-laboratory reproducibility testing were performed at three laboratories. Each of the three laboratories tested twelve samples in triplicate on five different days. The results of the study are summarized in the table below.
| Table 11: Inter-laboratory, Intra-assay and Inter-assay Reproducibility | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Plexus VCA IgM | Plexus Heterophile Antibody | ||||||||||
| ID | Intra-assay & Inter-assay%CV | Inter-Lab | ID | Intra-assay & Inter-assay%CV | Inter-Lab | ||||||
| MeanIndex | Intra-assay | Inter-assay | MeanIndex | % CV | MeanIndex | Intra-assay | Inter-assay | MeanIndex | % CV | ||
| 6 | 4.48 | 2.2% | 13.7% | 4.48 | 8.8% | 6 | 6.12 | 3.0% | 16.7% | 6.12 | 14.1% |
| 5 | 2.67 | 4.2% | 15.0% | 2.67 | 10.0% | 2 | 4.46 | 3.8% | 15.8% | 4.46 | 10.2% |
| 2 | 2.08 | 2.4% | 18.7% | 2.08 | 16.3% | 4 | 2.19 | 5.0% | 13.8% | 2.19 | 1.9% |
| 4 | 1.24 | 3.6% | 13.2% | 1.24 | 6.7% | 3 | 1.20 | 6.1% | 15.8% | 1.20 | 5.2% |
| 12 | 1.12 | 4.4% | 25.3% | 1.12 | 9.0% | 13 | 0.74 | 6.4% | 14.0% | 0.74 | 7.2% |
| 8 | 0.98 | 5.2% | 22.1% | 0.98 | 16.0% | 8 | 0.55 | 5.7% | 12.8% | 0.55 | 3.3% |
| 3 | 0.77 | 6.1% | 28.2% | 0.77 | 24.3% | 5 | 0.27 | 8.3% | 47.2% | 0.27 | 47.8% |
| 13 | 0.59 | 6.1% | 46.8% | 0.59 | 51.8% | 11 | 0.14 | 5.6% | 20.2% | 0.14 | 3.8% |
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved, swooping shape to the left of the word. Below the word "FOCUS" is a horizontal line, and below that line is the word "Diagnostics" in a smaller, sans-serif font.
510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M
Prepared Date: July 22, 2008
Page 12 of 13
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Inter-Lot Reproducibility
The inter-lot reproducibility was evaluated with eleven (11) samples in triplicates on three (3) lots of Plexus EBV kit. The results of the study are summarized in the table below.
| Table 12: Inter-lot Reproducibility | |||||
|---|---|---|---|---|---|
| Plexus VCA IgM | Plexus Heterophile Antibody | ||||
| ID | Mean Index | %CV | ID | Mean Index | %CV |
| 6 | 4.64 | 5.2% | 6 | 5.65 | 3.8% |
| 5 | 2.83 | 7.6% | 2 | 4.42 | 4.5% |
| 2 | 2.09 | 6.0% | 4 | 2.05 | 4.3% |
| 4 | 1.13 | 5.0% | 3 | 1.12 | 5.6% |
| 8 | 0.87 | 16.9% | 13 | 0.78 | 7.2% |
| 12 | 0.84 | 17.5% | 8 | 0.54 | 10.6% |
| 3 | 0.71 | 17.1% | 5 | 0.44 | 37.9% |
| 13 | 0.60 | 24.4% | 11 | 0.13 | 8.4% |
| 7 | 0.05 | 19.4% | 7 | 0.04 | 14.8% |
| 11 | 0.05 | 16.0% | 12 | 0.04 | 20.4% |
| 1 | 0.04 | 19.3% | 1 | 0.03 | 18.8% |
Cross-Reactivity
A cross-reactivity study was performed to determine if samples disease states and other potentially cross-reactivity factors interfere with test results when tested with the Plexus EBV IgM kit. A panel of (Antinuclear Antibody test (ANA) n=28, Cytomegalovirus (CMV) n=25, Herpes Simplex Virus-1 (HSV-1) and Herpes Simplex Virus-2 (HSV-2) n =2, Rheumatoid Factor (Rh) n=29, Rubella Virus n=5, and Varicella-Zoster Virus (VZV) n=42). samples for each cross reactant were evaluated for possible cross reactivity with the Plexus EBV IgM kit for each of the two (VCA and Heterophile) IgM analyte. The test samples were also evaluated on commercially available ELISA and heterophile rapid test. The majority of all samples that elicit a negative result were also confirmed negative by the corresponding commercially available tests, showing that the Plexus EBV IgM kit did not have additional cross-reactivity
| Table 13: Cross-Reactivity | ||||||||
|---|---|---|---|---|---|---|---|---|
| Cross Reactives | N | Method | EBV VCA IgM | EBV Heterophile | ||||
| Positive | Equivocal | Negative | Positive | Equivocal | Negative | |||
| ANA | 28 | Plexus | 0 | 2 | 26 | 0 | 0 | 28 |
| ELISA | 0 | 0 | 28 | 0 | 0 | 28 | ||
| Discrepants | 22 | 0 | ||||||
| Cytomegalovirus(CMV) | 25 | Plexus4 | 2 | 1 | 21 | 0 | 0 | 24 |
| ELISA | 1 | 0 | 24 | 0 | 0 | 25 | ||
| Discrepants | 51 | 14 | ||||||
| HSV 1 & HSV 2 | 2 | Plexus | 0 | 0 | 2 | 0 | 0 | 2 |
| ELISA | 0 | 0 | 2 | 0 | 0 | 2 | ||
| Discrepants | 0 | 0 | ||||||
| Rheumatoid Factor(Rh) | 29 | Plexus | 4 | 0 | 25 | 0 | 0 | 29 |
| 29 | ELISA | 0 | 0 | 29 | 0 | 0 | 29 |
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, swooping line is positioned to the left of the word "FOCUS", adding a dynamic element to the design.
510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 13 of 13
| Discrepants | 4 | 0 | ||||||
|---|---|---|---|---|---|---|---|---|
| Rubella | 5 | Plexus | 0 | 0 | 5 | 0 | 0 | 5 |
| ELISA | 0 | 0 | 5 | 0 | 0 | 5 | ||
| Discrepants | 0 | 0 | ||||||
| Varicella-zoster(VZV) | 42 | Plexus | 2 | 1 | 39 | 2 | 0 | 40 |
| ELISA | 1 | 2 | 39 | 2 | 0 | 40 | ||
| Discrepants | 33 | 0 |
1 One Equivocal Sample; 2 Two Equivocal Samples; "Three Equivocal Samples; 4 One Invalid Sample
Sample Storage and Handling
Fifteen (15) negative and positive for EBV IgM samples were used to assess the reactivity of unfrozen sample against samples that were frozen and thawed for up to five cycles. No effect was observed for any of the freezethaw cycling in either the positive or negative sample.
Interference
The test performance was evaluated with the presence of interfering substances. Four samples, two positive and two negative for EBV VCA IgM and heterophile antibody by Plexus EBV IgM were used in the study. Baseline ERV IgM levels were established for each sample before interferents were added. Two concentration levels of each interferent were used: triglycerides (1 mg/mL), albumin (6 mg/mL and 60 mg/mL), bilirubin (0.02 mg/mL and 0.2 mg/mL), and hemoglobin (22 mg/mL) The higher interferent concentrations represent levels that exceed the expected human range. All samples were evaluated to determine if these interfering substances affect the assay. No interference was observed for any of the substances in either the positive or negative sample.
{13}------------------------------------------------
Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 4 2008
Focus Diagnostics, Inc. C/O Deborah Morris 10703 Progress Way Cypress, California 90630
Re: K073381
Trade/Device Name: Plexus EBV IgM Multi-Analyte Diagnostics Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr Virus Serological Reagents Regulatory Class: Class I Product Code: LJN Dated: November 30, 2007 Received: December 3, 2007
Dear Ms. Morris:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
{14}------------------------------------------------
Page 2 - Focus Diagnostics, Inc.
notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Salez a Agre
Sally A. Hojvat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
Plexus EBV IgM Multi-Analyte Diagnostics
Indications for Use:
Focus Diagnostics' Plexus™ EBV IgM Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis.
The performance of this assay has not been established for use in the diagnosis of nasopharyngeal carcinoma and Burkitt's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
the Schf
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
§ 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).