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510(k) Data Aggregation
(36 days)
BIOPLEX 2200 EBV IGM KIT
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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