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The BioPlex 2200 ToRC IgG kit is a multiplex flow immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella. and the qualitative detection of IgG antibodies to Cytomegalovirus (CMV) in human serum and EDTA or heparinized plasma.

The ToRC IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.

This kit is intended as an aid in the determination of serological status to.T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.

Performance characteristics for T. gondii and Rubella have not been evaluated in immunocompromised or immunosuppressed individuals. Performance characteristics for CMV have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at a point of care.

The BioPlex® 2200 ToRC IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. "ToRC" is an acronym for individual tests to detect antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV). Three (3) different populations of dyed beads are coated with cell lysates bearing T. gondii, Rubella, or CMV antigens.

The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel: the mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads, and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the . fluorescence of the attached PE. Raw data are calculated in relative fluorescence intensity (RFI).

Three additional dyed beads, Internal Standard Bead (ISB), Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma.

The instrument is calibrated using a set of six (6) distinct calibrator vials. the BioPlex 2200 ToRC IgG Calibrator Set. For T. gondii and Rubella, six (6) vials, representing six (6) different levels of antibody concentrations, are used for quantitative calibration, and results for patient samples are expressed in IU/mL. For T. gondii, results of ≤ 9 IU/mL are negative, 10 and 11 IU/mL are equivocal, and results of > 12 IU/mL are reported as positive. For Rubella, results of ≤ 7 IU/mL are reported as negative, 8 and 9 IU/mL are equivocal, and ≥ 10 IU/mL are reported as positive. For CMV, four (4) vials, representing four (4) different antibody concentrations, are used for qualitative calibration. CMV results are expressed as an antibody index (AI) and results of ≤ 0.8 AI are negative, 0.9 and 1.0 AI are equivocal, and results of ≥ 1.1 AI are reported as positive.

The BioPlex 2200 ToRC IgG Control Set includes a negative control as well as two (2) multi-analyte positive controls. The BioPlex ToRC IgG Low Positive Control contains antibodies for T. gondii, Rubella and CMV and the BioPlex ToRC IgG High Positive Control contains antibodies for T. gondii and Rubella. The BioPlex ToRC IgG Positive Controls are manufactured to give positive results, with values above the cut-off for each specific analyte. The BioPlex ToRC IgG Negative Control is manufactured to give negative results, with values below the cut-off for each specific analyte. The recommended frequency for performing quality control is once every 24-hour testing period. Performing quality control is also necessary after each new assay calibration and certain service procedures.

This document describes a Special 510(k) submission for a modification to the BioPlex® 2200 ToRC IgG kit. The only change being made is the frequency of Reagent Pack Quality Control (QC) testing from once per pack and per day to once per day and per new reagent pack lot.

Therefore, the acceptance criteria and study information provided below relate to demonstrating that this change in QC frequency does not negatively impact the performance of the device and maintains substantial equivalence to the predicate device.

1. A table of acceptance criteria and the reported device performance

The document states that the modification involved a change in QC testing frequency, and the "Based on the conclusion of the risk management report, the modified QC procedure fulfills the requirements of the specifications of the design control process." This implies that the acceptance criteria are met if the device maintains its original performance characteristics with the new QC frequency. The performance characteristics of the original device are not provided in this document, as the focus is solely on supporting the change in QC frequency.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a separate "test set" in the traditional sense for evaluating the performance of the modified device against a ground truth. Instead, the justification for the change in QC frequency relies on a Risk Analysis method and FMEA. Therefore, there is no sample size for an external "test set" and no specific data provenance related to patient samples is mentioned for this particular modification. The study focused on demonstrating equivalence through internal quality control and risk management activities.

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. As described above, there was no external "test set" with a ground truth established by experts. The substantiation for this modification comes from internal risk assessment and design control activities.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no external "test set" requiring adjudication.

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 device is an in vitro diagnostic (IVD) multiplex flow immunoassay system, not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement with AI are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is an IVD device; its performance is inherently "standalone" in the sense that it automates the testing process. The document does not describe separate algorithm-only studies beyond the reported performance of the integrated system. The focus of this 510(k) is a change in QC frequency, not a new algorithm or core performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for this 510(k) modification. The original device's performance would have been established against a ground truth (e.g., reference methods, clinical diagnosis), but this document focuses on demonstrating that the change in QC frequency does not alter those established performance characteristics. The "ground truth" for this submission is the successful completion of the risk management process and the conclusion that the modified QC procedure meets the requirements and maintains substantial equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device that would typically involve a "training set" for an algorithm.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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