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The BioPlex® 2200 EBV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of two (2) separate analytes: Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum. The test system can be used in conjunction with the BioPlex® 2200 EBV IgG kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).

The BioPlex® 2200 EBV IgM kit is intended for use with the Bio-Rad BioPlex® 2200 System.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas.

The BioPlex® 2200 EBV IgM Calibrator Set is intended for the calibration of the BioPlex® 2200 EBV IgM Reagent Pack.

The BioPlex® 2200 EBV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex® 2200 Instrument and BioPlex® EBV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex® EBV IgM Control Set has not been established with any other EBV IgM antibody assays.

The BioPlex 2200 EBV IgM kit is a multiplexed micro particle bead based immunoassay for the qualitative detection of IgM antibodies to EBV VCA GP125/p18 and Heterophile antigen in human serum using the Luminex flow cytometry technology. The BioPlex 2200 EBV IgM Calibrators set consists of two (2) distinct serum based calibrators. The BioPlex 2200 EBV IgM Control set consists of 2 vials of the BioPlex 2200 EBV IgM Positive Control and 2 vials of the BioPlex 2200 EBV IgM Negative Control. The positive controls are provided in a human serum matrix made from defibrinated plasma with added antibodies to EBV VCA GP125/p18 and Heterophile antigen derived from human disease state plasma. The negative controls are provided in a human serum matrix made from defibrinated plasma.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "VCA IgM Performance": {
      "Acceptance Criteria": "(Implied) Performance equivalent to Predicate device ([K062213](https://510k.innolitics.com/search/K062213))",
      "Reported Device Performance": {
        "Positive Percent Agreement (PPA)": "98.7% (78/79)",
        "Negative Percent Agreement (NPA)": "98.7% (528/535)"
      }
    },
    "Heterophile IgM Performance": {
      "Acceptance Criteria": "(Implied) Performance equivalent to Predicate device ([K062213](https://510k.innolitics.com/search/K062213))",
      "Reported Device Performance": {
        "Positive Percent Agreement (PPA)": "100% (28/28)",
        "Negative Percent Agreement (NPA)": "100% (593/593)"
      }
    },
    "Precision/Reproducibility (Total Precision %CV) - VCA IgM": {
      "Acceptance Criteria": "(Implied) Comparable or improved CVs relative to Predicate device",
      "Reported Device Performance (Modified Device)": {
        "High Negative": "5.6% - 9.0%",
        "Near Cutoff": "6.4% - 7.7%",
        "Low Positive": "5.1% - 8.1%",
        "High Positive": "2.7% - 4.5%"
      }
    },
    "Precision/Reproducibility (Total Precision %CV) - Heterophile IgM": {
      "Acceptance Criteria": "(Implied) Comparable or improved CVs relative to Predicate device",
      "Reported Device Performance (Modified Device)": {
        "High Negative": "7.9% - 8.4%",
        "Near Cutoff": "7.0% - 7.1%",
        "Low Positive": "5.4% - 6.0%",
        "High Positive": "5.1% - 5.3%"
      }
    },
    "Analytical Specificity (Interference)": {
      "Acceptance Criteria": "(Implied) Percent change in signal within acceptable limits and equivalent to original device. Specifically, for predicate, ranged from -5.6% to 5.6% for VCA IgM and -7.4% to 4.2% for Heterophile IgM.",
      "Reported Device Performance": {
        "VCA IgM": "Percent change in signal ranged from -10.0% to 0.0%",
        "Heterophile IgM": "Percent change in signal ranged from -11.1% to 7.4%"
      }
    },
    "LSP Remediation (Risk Analysis)": {
      "Acceptance Criteria": "Residual Risk acceptability criteria (RPN score) ≤ 19.",
      "Reported Device Performance": "RPN scores ranged from 6 for false positive results to 12 for false negative results for both EBV VCA IgM and Heterophile IgM assays."
    },
    "LSP Remediation (Contamination Studies)": {
      "Acceptance Criteria": "Adequate protection against bacteria and mold contamination, with only minimal signal loss within specifications even at extreme contamination levels.",
      "Reported Device Performance": "Proposed EBV IgM formulation provides adequate protection against bacteria and mold contamination as compared to reagent packs without remediation."
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": {
    "Method Comparison (Prospective)": {
      "Sample Size": "N=622 (individuals where EBV IgM test was ordered)",
      "Data Provenance": "Prospective, human serum samples."
    },
    "Retrospective Positive Samples": {
      "Sample Size": "N=81 (for both VCA IgM and Heterophile IgM)",
      "Data Provenance": "Retrospective, from individuals presumptively positive for either VCA IgM or Heterophile IgM."
    },
    "Precision Panel": {
      "Sample Size": "9 serum panel members for each analyte.",
      "Data Provenance": "Panel members prepared by Bio-Rad Laboratories."
    }
  },
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. Ground truth for comparison studies was established by the predicate device (BioPlex 2200 EBV IgM Kit, [K062213](https://510k.innolitics.com/search/K062213)) or by presumptive positive status for retrospective samples. No independent expert review for ground truth determination is mentioned.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The study compares the performance of the modified device directly against a predicate device, which serves as the reference, or uses samples presumptively positive. There is no mention of an adjudication process by human experts.",
  "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable. This is not a study involving human readers or AI assistance. It is a comparison of an in vitro diagnostic (IVD) device (EBV IgM kit) to a predicate IVD device.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, this is a standalone performance study. The BioPlex 2200 EBV IgM kit is an automated system (algorithm only) for qualitative detection of antibodies. Its performance is evaluated independently of human interpretation, beyond the standard use of such a diagnostic tool in a clinical laboratory.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth for the comparison studies was primarily established by the performance of the predicate device (BioPlex 2200 EBV IgM Kit, [K062213](https://510k.innolitics.com/search/K062213)). For retrospective positive samples, their 'presumptively positive' status served as a form of ground truth, likely based on prior diagnostic results or clinical indicators, though the specific method of presumptive positivity is not detailed.",
  "8. The sample size for the training set": "Not applicable. This document describes a modification to an existing device and its performance evaluation, not the development or training of a new algorithm where a dedicated training set would typically be described. The study uses patient samples for comparison and precision, not for model training.",
  "9. How the ground truth for the training set was established": "Not applicable, as there is no described training set for the modified device."
}

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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.

1. 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.
2. 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.
3. 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.

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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The Zeus Scientific, Inc. AtheNA Multi-Lyte® EBV VCA IgM Test System is a microparticle-based immunoassay intended for the qualitative detection of IgM class antibody to the Epstein-Barr virus, viral capsid antigen in human serum using the AtheNA Multi-Lyte® System. The test system is intended to be used for the laboratory diagnosis of EBV-associated infectious mononucleosis and provides epidemiological information on the diseases caused by Epstein-Barr virus.

The Zeus Scientific, Inc. AtheNA Multi-Lyte® EBV VCA IgM Test System is a microparticle-based immunoassay.

This is a tricky request as the provided text is a letter from the FDA regarding a 510(k) clearance, not a study report. It states that the device is substantially equivalent to a legally marketed predicate device, but it does not contain the details of any specific study that would directly provide acceptance criteria and reported device performance in the format requested.

The letter explicitly states: "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..." This indicates the approval is based on comparison to existing devices, not necessarily a new, standalone performance study with defined acceptance criteria provided in this document.

Therefore, I cannot directly extract the specific information requested about acceptance criteria and a study proving device performance from the provided text. The document is an approval letter, not a study report.

If you had a study report for the AtheNA Multi-Lyte® EBV VCA IgM Test System, I would be able to populate the requested table and answer the questions.

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For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For in vitro diagnostic use only.

The SeraQuest VCA IgM test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgM antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum.

The Calibrators in the SeraQuest VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

Here's a breakdown of the acceptance criteria and study details for the SeraQuest® VCA IgM device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria for the SeraQuest® VCA IgM device beyond the 'Overall agreement' percentage. It primarily demonstrates substantial equivalence to a predicate device using comparative clinical testing.

Table 1. SeraQuest® VCA IgM Performance Against Zeus' EBV-VCA IgM EIA Test

Note: The acceptance criteria here are inferred from the reported overall agreement, as no specific quantitative thresholds were explicitly defined in the document for FDA clearance.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 113 specimens
   • Data Provenance: Archival patient specimens tested at SeraQuest, Miami, FL (United States). The study is retrospective.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • The document does not specify the number of experts or their qualifications used to establish the ground truth. Instead, the predicate device (Zeus' EBV-VCA IgM ELISA test) served as the comparator for the test set.

3. Adjudication Method:

   • The document does not describe a specific adjudication method such as 2+1 or 3+1. The results of the SeraQuest test were directly compared against the results of the Zeus' EBV-VCA IgM ELISA test.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not conducted. This study is a comparison of a new diagnostic device against a predicate device, not a study of human reader improvement with or without AI assistance.

5. Standalone Performance Study:

   • Yes, a standalone performance study was conducted. The SeraQuest VCA IgM device's performance was evaluated by testing 113 archival patient specimens and comparing its results directly with those obtained from the predicate device (Zeus' EBV-VCA IgM ELISA test). This represents the algorithm/device's performance without human intervention in the result interpretation beyond what is inherent in reading an EIA test.

6. Type of Ground Truth Used:

   • The "ground truth" for this study was established by the results obtained from the predicate device, Zeus' EBV-VCA IgM ELISA test. This is a comparative study where the predicate device's results serve as the reference.

7. Sample Size for the Training Set:

   • The document does not provide information on a training set or its sample size. As this is a diagnostic device comparison for substantial equivalence, it's likely a fully developed product was tested, not one undergoing a machine learning training phase.

8. How the Ground Truth for the Training Set was Established:

   • Since no training set information is provided, the method for establishing its ground truth is also not available.

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1. For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection.
2. For in vitro diagnostic use only.
3. A positive result is presumptive for the detection of anti-Epstein-Barr virus IgM antibodies and presumptive for the diagnosis of acute or recent Epstein-Barr virus infection.

The SeraQuest EB VCA IgM test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgM antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum.

The Calibrators in the SeraQuest EB VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

The provided document describes the SeraQuest EB VCA IgM test, an enzyme immunoassay designed to detect IgM antibodies to Epstein-Barr virus capsid antigen in human serum. This diagnostic test aims to differentiate active or recent EBV infection from past infection.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of sensitivity, specificity, or positive/negative predictive values. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device by comparing overall agreement.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 157 specimens.
• Data Provenance: "Archival Patient Specimens Tested at SeraQuest, Miami, FL". This indicates the data is retrospective and from the USA (Miami, FL).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. The comparison is made against a predicate device (Gull Laboratories' EBV IgM ELISA), which acts as the reference for classification (positive, negative, equivocal).

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method involving multiple readers or experts to resolve discrepancies between the SeraQuest test and the predicate device. The results are presented as a direct comparison between the two tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. The study is a direct comparison of the new device's performance against a predicate device, not an evaluation of human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the study describes the standalone performance of the SeraQuest EB VCA IgM test. As an enzyme immunoassay, it produces a quantitative result (Index value) which is then interpreted qualitatively (positive, negative, equivocal) without direct human-in-the-loop performance during the result generation. The comparison is between the standalone performance of the new device and the standalone performance of the predicate device.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate device, Gull Laboratories' EBV IgM ELISA test. The study evaluates the concordance of the SeraQuest test with this predicate rather than an independent, gold-standard ground truth like pathology or long-term clinical outcomes.

8. The Sample Size for the Training Set

The document does not specify a separate training set size. The 157 specimens are referred to as "archival patient specimens" used for the comparison study. As this is an immunoassay and not a machine learning algorithm in the modern sense that requires explicit "training," the concept of a separate training set is not directly applicable in the terms usually associated with AI/ML development. The "in-house standard" mentioned for assigning Index values to calibrators might involve some internal standardization, but it's not a training set in the context of supervised learning.

9. How the Ground Truth for the Training Set Was Established

Given that a training set in the AI/ML context is not explicitly mentioned or relevant, the method for establishing its ground truth is not applicable here. The test performance is evaluated against the predicate device.

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The Copalis® EBV-M Assay uses Coupled Particle Light Scattering technology in a microparticle agglutination-based assay for the qualitative detection of IgM antibodies to the EBV VCA antigen. The assay is designed for human serum using the Copalis® I Immunoassay System. The presence of VCA IgM antibodies is used as an aid in the diagnosis of EBV associated mononucleosis when used in conjunction with other EBV serologies in pediatric, adult, transplant donor and transplant recipient populations.

The Copalis® EBV-M Antibody Assay uses Coupled Particle Light Scattering technology in a microparticle agglutination-based assay for the qualitative detection of IgM antibodies to the EBV VCA antigen. The assay is designed for human serum using the Copalis I® Immunoassay System. The presence of VCA IgM antibodies is used as an aid in the diagnosis of EBV associated mononucleosis when used in coniunction with other EBV serologies in pediatric, adult, transplant donor and transplant recipient populations.

KIT DESCRIPTION: Coupled Particle Light Scattering (Copalis®) technology provides a rapid method for the measurement of antibodies to specific pathogens. The Copalis® EBV-M Antibody Assay is a microparticle agglutination test using the Copalis® light scattering technology. Polystyrene microparticles are coated with svnthetic VCA antigen and are contained within a special covered reaction well in the test cup. The dried reagent is reconstituted with a reaction buffer on the instrument at the start of the assay. Patient sample is added to the reaction mixture and incubated for 10 minutes. The presence of IgM antibodies specific to the VCA antigen in the patient sample results in agglutination of the monomer microparticles to form aggregates. The reaction mixture is passed through a flow cell and the instrument uses light scattering technology to measure the monomer concentration. The decrease in the monomer population resulting from agglutination is related to the amount of antibody in the sample. The residual monomer concentration in each reaction mixture is compared to a cutoff values to determine sample reactivity and nonreactivity.

Acceptance Criteria and Study for Copalis® EBV-M Antibody Assay

1. Acceptance Criteria and Reported Device Performance

The provided document describes the performance of the Copalis® EBV-M Antibody Assay against various patient populations. The acceptance criteria for a diagnostic assay typically involve evaluating its sensitivity and specificity in relevant disease states. While explicit numerical acceptance criteria are not stated as "acceptance criteria," the reported performance metrics serve as the evidence for meeting the implicit criteria of a clinically effective diagnostic. The data is presented for different patient populations (Primary Disease, Reactivated Disease, SeroNegative, Apparently Healthy Adult, Transplant Recipients, Transplant Donors), with the focus on Sensitivity and Specificity of detecting EBV VCA IgM.

The predicate device for comparison is the Gull Laboratories EBV IgM IFA, and the performance is presented in comparison to "expected marker patterns" which represent the established diagnostic criteria based on a panel of EBV markers.

Here's a table summarizing the reported device performance for specificity, as this appears to be a key metric where the device might differ from a simple expectation of 0% IgM in non-primary infection states. Sensitivity for Primary Disease is 100%, indicating perfect detection in acute cases.

Note on "Acceptance Criteria": The document does not explicitly state numerical thresholds as "acceptance criteria." However, regulatory submissions often rely on demonstrating performance that is "substantially equivalent" to a legally marketed predicate and is deemed clinically acceptable by experts. The high sensitivity for primary disease (100%) and generally high specificity across various non-primary infection groups, along with direct comparison to IFA results and expected serological patterns, serve as the basis for acceptance. The presence of IgM in reactivated disease is specifically addressed by referencing literature, indicating a nuanced understanding of expected results rather than a rigid "no IgM" rule.

2. Sample Sizes Used for the Test Set and Data Provenance

The study utilized a total of 421 distinct samples across various disease states and populations.

• Primary Disease: 12 pediatric, 59 adult samples (total 71)
• Reactivated Disease: 39 samples
• SeroNegative: 42 pediatric, 8 adult samples (total 50)
• Apparently Healthy Adult Population: 97 samples
• Transplant Recipients (Reactivated): 41-42 samples (reported as 41 for specificity, 42 for agreement and prevalence Copalis)
• Transplant Donors: 50-53 samples (reported as 50 for specificity and agreement, 46 for prevalence Copalis, 53 for prevalence IFA)
• EBV Screening Population: 14 pediatric, 29 adult samples (total 43) - this appears to be an inclusive group where primary, reactivated, seronegative, or past cases were assessed for VCA IgM presence.
• Serial Samples: 7 patients

Data Provenance:

• Country of Origin: The samples were collected from patients representing the "eastern, midwestern and western United States." Specific cities or institutions are not detailed.
• Retrospective or Prospective: Samples were a mix of "Fresh (12%) and frozen (88%) samples," which generally indicates a retrospective collection of banked samples. However, the exact nature of how these samples were obtained in relation to the study design (i.e., whether they were specifically collected for this assay validation or were pre-existing clinical samples) is not explicitly stated as retrospective or prospective, but the use of frozen samples leans heavily towards retrospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the "number of experts used to establish the ground truth" or their specific qualifications (e.g., "radiologist with 10 years of experience").

However, the ground truth was established by comparison to "expected patterns of serological testing results for the 4 EBV markers (EBV VCA IgG and IgM, EBNA, and EA), and for primary infection, heterophile test," and IFA results. This implies that the interpretation of these serological patterns is based on established clinical guidelines and expert consensus in the field of infectious disease diagnostics, likely developed through the collective knowledge of clinical pathologists, infectious disease specialists, and laboratory professionals. The serological pattern itself acts as the "expert consensus" ground truth.

4. Adjudication Method for the Test Set

The adjudication method is implicit and based on a multi-marker serological panel.

• The "expected marker patterns for the 4 EBV markers (EBV VCA IgG and IgM, EBNA, and EA), and for primary infection, heterophile test" served as the primary adjudication criterion for classifying samples into disease states (Seronegative, Primary, Reactivated, Past). This means that multiple established tests were used to categorize each sample.
• For cases where the Copalis® assay results differed from the expected pattern or IFA, the report notes cases of "Copalis equivocal/IFA positive," "Copalis equivocal/IFA negative," "Copalis equivocal/IFA non-specific staining," and "Copalis negative/IFA nss."
• "Equivocal results by Copalis or IFA or non-specific staining by IFA were not included in the calculations" of sensitivity and specificity, indicating a form of exclusion or consensus-based adjudication where ambiguous cases from either the test device or the reference method were set aside for the core performance metrics.

There is no mention of a traditional expert panel consensus (e.g., 2+1 or 3+1 radiologists) typically found in imaging studies, as this is a laboratory assay.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study focuses on the performance of human readers, sometimes with and without AI assistance, especially in medical imaging. The Copalis® EBV-M Antibody Assay is an automated in vitro diagnostic (IVD) assay; its performance is measured directly by the instrument, not by human interpretation of its raw output in a way that would lend itself to an MRMC study. The comparison is between the assay's results and established serological patterns/predicate device (IFA).

6. Standalone Performance Study

Yes. The entire performance data section describes the standalone performance of the Copalis® EBV-M Antibody Assay. The assay's ability to detect IgM antibodies to the EBV VCA antigen is evaluated directly against the established serological ground truth for different patient populations. The results for sensitivity, specificity, and agreement are for the algorithm (assay) itself.

7. Type of Ground Truth Used

The type of ground truth used is a multi-marker serological panel and comparison to a predicate device (IFA), representing expert consensus derived from established diagnostic criteria.

• For classification into disease states (Primary, Reactivated, Seronegative, Past infection), the ground truth relied on a combination of:
  • EBV VCA IgG and IgM (IFA results)
  • EBNA (Epstein-Barr Nuclear Antigen)
  • EA (Early Antigen)
  • Heterophile test results (for primary infection)
• The expected patterns of reactivity for these markers define the "true" disease state. This is a form of "expert consensus" based on established clinical diagnostic algorithms for EBV infection.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The performance data provided is for the test set. For an in vitro diagnostic assay, the "training" may refer to the internal development and calibration of the assay during its creation, which is typically not disclosed in detail in a 510(k) summary, or samples used for optimization that are distinct from the final validation set. There's no indication that machine learning was used in a way that would require a distinct "training set" in the modern sense of AI/ML; this is a traditional immunoassay.

9. How Ground Truth for the Training Set Was Established

As no separate training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided. If internal development samples were used, their ground truth would likely have been established by similar serological panels and predicate device comparisons as described for the test set.

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ImmunoWELL VCA IgM Test is for the qualitative detection of IgM antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

Microtiter ELISA kit detecting VCA IgM antibodies

This document describes the ImmunoWELL VCA IgM Test, a microtiter ELISA kit designed for the qualitative detection of IgM antibodies to Epstein-Barr Virus (EBV) viral capsid antigen (VCA) in human serum. This test is intended to be used as an aid in diagnosing infectious mononucleosis (IM) when used alongside other EBV tests.

The submission claims substantial equivalence to the Epstein-Barr Viral Capsid Antigen IgM ELISA Kit by Gull Laboratories, Inc. Both devices utilize VCA affinity-purified antigen and measure antibodies using ELISA technology in a microtiter assay format.

Here's an analysis of the acceptance criteria and the study performance based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity or specificity thresholds). Instead, the study's goal was to demonstrate substantial equivalence to the predicate device. The performance is reported in terms of agreement with the predicate device.

Note: The table presented in the input is a 2x2 contingency table comparing the ImmunoWELL VCA IgM Test (labeled "GB") against the Gull EIA.

From this table:

• True Negatives (both negative): 88
• False Negatives (ImmunoWELL negative, Gull positive): 1
• False Positives (ImmunoWELL positive, Gull negative): 0
• True Positives (both positive): 4

This implies:

• Total Gull Negative: 88
• Total Gull Positive: 5 (4+1)
• Total ImmunoWELL Negative: 89 (88+1)
• Total ImmunoWELL Positive: 4

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for the Test Set: 93 samples (88 negative by predicate + 4 positive by predicate + 1 discrepant). The table shows a total of 93 samples analyzed in the comparison study.
• Data Provenance: The document does not explicitly state the country of origin. It mentions "sera from suspected patients," suggesting these were patient samples collected in a clinical context. The study is retrospective, as it involves testing existing serum samples and comparing the results to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The concept of "experts" and their qualifications for establishing ground truth is not applicable in this context. The "ground truth" for the test set is established by the results of the predicate device (Gull Laboratories' Epstein-Barr Viral Capsid Antigen IgM ELISA Kit). The study design compares the new device's results against those of an already legally marketed device, considering the predicate device's results as the reference.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The comparison is a direct concordance analysis between the new device and the predicate device. Discrepancies (one sample was negative by ImmunoWELL but positive by Gull EIA) are noted, but no further adjudication (e.g., by a third expert or a tie-breaker rule) is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of a diagnostic kit, not on the interpretation skills of human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, this is a standalone study of the device (ELISA kit). The performance reported is that of the ImmunoWELL VCA IgM Test kit itself, without human interpretation as a variable. The "human-in-the-loop" concept is more relevant to imaging or AI-assisted diagnostic systems.

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the ImmunoWELL VCA IgM Test was comparison to a legally marketed predicate device (Epstein-Barr Viral Capsid Antigen IgM ELISA Kit, Gull Laboratories, Inc.). The predicate device's results served as the reference standard for assessing the new device's performance.

8. The Sample Size for the Training Set

The document does not provide information on a "training set." This type of diagnostic device (ELISA kit) typically undergoes development and validation using laboratory methods, rather than machine learning training sets. Therefore, there's no mention of a traditional "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of this device's development (which is assumed to be a traditional ELISA kit development rather than an AI algorithm), the establishment of ground truth for a training set is not applicable or described in the provided text.

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