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The BioPlex® 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen-1 (EBV NA-1), Viral Capsid Antigen (EBV VCA), and Early Antigen diffuse (EBV EA-D) in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgM kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).

The EBV IgG 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 Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. This test system also confirms reactive test results form non-treponemal based screening assays.

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

The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors

Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.

The EBV IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional ElA, but permits simultaneous detection and identification of many antibodies in a single tube. Three (3) different populations of beads are coated with E. coli derived recombinant proteins, EBV NA-1 (28kD and 45kD), EBV VCA p18 (40kD), and EBV EA-D (28kD) associated with infectious mononucleosis. 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, antihuman 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 is calculated in relative fluorescence intensity (RFI).

Three additional dyed beads, an Internal Standard Bead (ISB), a 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. Refer to the BioPlex 2200 System Operation Manual for more information. The instrument is calibrated using a set of seven (7) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semiquantitative calibration. The result for each of these antibodies is expressed as an antibody index (AI).

The Syphilis IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional ElA, but permits simultaneous detection and identification of many antibodies in a single tube. Three (3) different populations of beads are coated with recombinant proteins associated with T. pallidum (15kD. 17kD. and 47kD). The BioPlex 2200 System combines an aliquot of patient 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 is calculated in relative fluorescence intensity (RFI).

Three additional dyed beads, an Internal Standard Bead (ISB), a 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. Refer to the BioPlex 2200 System Operation Manual for more information.

The system is calibrated using a set of four (4) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. Four (4) vials representing two (2) or three (3) different antibody concentrations are used for calibration. Results are calculated for each of the three (3) antibodies and are compared against their own respective cut-off and are expressed as an antibody index (AI). A single result is reported after completing a composite analysis of all the antibodies (the highest AI value is reported).

This is a 510(k) premarket notification for device modifications to the BioPlex 2200 EBV IgG and Syphilis IgG kits. The modifications are related to reducing the frequency of Quality Control (QC) testing and adding protein stabilizers and protease inhibitors to the particle diluent. The document asserts that the performance of the modified QC test frequency is substantially equivalent to the current cleared kit, meaning no new clinical studies were conducted to prove device performance against acceptance criteria. Instead, a risk analysis was performed.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not provide specific quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) for the modified devices. The core assertion is that the devices remain substantially equivalent to their predicate devices due to internal design control activities and risk assessment, rather than new performance testing.

The acceptance criteria for the changes are related to the risk management report and ensuring the modified QC procedure fulfills the requirements of the specifications of the design control process. The reported "performance" for the modified components is that they are considered substantially equivalent.

2. Sample Size for the Test Set and Data Provenance

No specific test set sample size, country of origin, or whether data was retrospective or prospective is mentioned for a new study to prove device performance. The modifications were assessed through design control activities and risk analysis rather than new clinical trials or performance studies involving patient samples.

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

Not applicable. No new test set requiring expert ground truth establishment was conducted for the device modifications. The substantial equivalence determination was based on internal risk analysis and FMEA.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring adjudication was conducted.

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

No MRMC study was performed or mentioned. These devices are in vitro diagnostic kits, not AI-assisted reader systems.

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

Not applicable. These are diagnostic kits, not algorithms that operate without human interaction in the diagnostic process (though the instrument automates parts of it, the overall use involves human input and interpretation). The changes relate to QC frequency and reagent formulation, not the core analytical algorithm.

7. Type of Ground Truth Used

Not applicable for new device performance testing. The "ground truth" for the acceptance of these modifications was the internal design control process, FMEA, and risk analysis, which concluded that the modifications maintained substantial equivalence to the predicate devices. The predicate devices themselves would have had their performance validated against clinical ground truth (e.g., clinical diagnosis of infection) in their original 510(k) submissions.

8. Sample Size for the Training Set

Not applicable. The document describes modifications to existing in vitro diagnostic kits and does not involve machine learning algorithms with training sets.

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

Not applicable, as there is no training set mentioned.

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