Search Results

The OSOM® Mono Test is intended for the qualitative detection of infectious monomucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis.

The OSOM Mono Test uses color immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. In the test procedure, serum, plasma or whole blood is mixed with the Diluent. Then the Test Stick is placed in the mixture migrates along the membrane. If the specific IM heterophile antibody is present in the sample, it will form a complex with the bovine erythrocyte extract conjugated color particles. The complex will then be bound by bovine erythrocyte xtract immobilized on the membrane and a visible blue Test Line will appear to indicate a positive result.

The Sekisui Diagnostics OSOM Mono Test is a qualitative diagnostic device for infectious mononucleosis heterophile antibodies. The 510(k) submission [K181436] focuses on a device modification: replacing the prior capillary tube with the Microsafe capillary pipette for whole blood collection.

Here's an analysis of the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document provides limited detail on sample sizes for the "Compatibility Study". It states "All patients had negative results." The exact number of patients is not specified.

Data provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective for the non-clinical tests. Given the nature of a device modification focused on a component change, these tests are typically conducted in-house by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies described are non-clinical, focusing on the functionality of the new pipette, rather than clinical efficacy studies requiring expert interpretation of results.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the studies were non-clinical performance tests of a component, an adjudication method typically used for clinical interpretation of diagnostic results would not be applicable.

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 done. The study described is a non-clinical evaluation of a device component modification. The focus was not on human reader performance with or without AI assistance.

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

This is not applicable. The device, OSOM Mono Test, is an immunochromatographic dipstick test for heterophile antibodies, not an AI algorithm. The studies focused on the physical characteristics and compatibility of a new pipette component.

7. The Type of Ground Truth Used

• Volume Capability Study: The ground truth for this study was the actual dispensed volume measured by a calibrated method, compared against the target range of 50µL and 55µL.
• Compatibility Study: The ground truth for this study was the known negative status of the patient samples, allowing the assessment of whether the new pipette introduced false positive reactions or interfered with negative results.

8. The Sample Size for the Training Set

This is not applicable. The OSOM Mono Test is a rapid diagnostic test based on immunochromatographic principles, not a machine learning algorithm that requires a training set. The "device modification" refers to a physical component (pipette), not an algorithmic change.

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

This is not applicable as there is no training set for this type of device and modification.

Ask a specific question about this device

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."
}

Ask a specific question about this device

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 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.

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

BioPlex 2200 EBV IgM Control Set: 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 2200 EBV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 EBV IgM Control Set has not been established with any other EBV assays.

The BioPlex 2200 EBV IgM 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. Two (2) different populations of dyed beads are coated with proteins associated with infectious mononucleosis. One (1) is coated with an E. coli derived recombinant fusion protein, EBV VCA p18 (40kD), and the other is coated with horse erythrocyte stromal extract (heterophile antigen). The BioPlex 2200 System combines an aliquot of patient sample, sample diluent containing goat anti-human IgG, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgM antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess coniugate 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.

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 respectively. The instrument is calibrated using a set of two (2) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of two (2) vials representing two (2) different antibody concentrations is used for calibration. The result for each of these antibodies is expressed as an antibody index (AI).

Here's a summary of the acceptance criteria and study details for the BioPlex 2200 EBV IgM Kit, Calibrators, and Controls, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria in numerical targets for performance metrics like sensitivity, specificity, or %CV. Instead, it presents the results of the studies conducted and implies that these results were deemed acceptable for FDA clearance. The performance is assessed through reproducibility, precision, and comparative testing against predicate devices and known serological patterns.

However, we can infer performance metrics from the results provided:

2. Sample Size and Data Provenance

• Test Set (Comparative Testing):

  • Main Comparative Study: 621 banked serum samples from patients for whom an EBV test was ordered. Two samples were excluded due to RBB errors, resulting in N=619 for initial analyses and N=618 for serological pattern comparisons.
    • Provenance: 3 U.S. clinical testing sites (retrospective, banked serum samples).
  • Known EBV VCA IgM Positive Samples: 100 purchased EBV VCA IgM positive samples.
    • Provenance: A U.S. clinical testing site (retrospective, purchased samples).

• Reproducibility and Precision Studies: These studies used "panel members" prepared by Bio-Rad Laboratories. The number of panel members was 6 (2 high positive, 2 near cutoff, 2 negative). Each panel member was tested multiple times across days and sites. These are typically internal validation samples, not patient data in the same way as the comparative testing.

3. Number of Experts and Qualifications

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. The ground truth in comparative testing was established by "corresponding commercially available microplate EIA/agglutination tests" and subsequent serological pattern characterization. It is implied that these predicate devices and the serological algorithm (Table 16) serve as the 'expert' reference. For the purpose of result interpretation, the algorithm defines different EBV serological statuses based on various antibody responses.

4. Adjudication Method

The document does not describe an adjudication method for the test set by human experts in the traditional sense (e.g., 2+1, 3+1). Instead, the results of the BioPlex 2200 system were compared to the results of predicate commercial assays. For percent agreement calculations in comparative testing, BioPlex 2200 "equivocal results were assigned to the opposite clinical interpretation than that of the corresponding reference assay result." This acts as a conservative rule for calculating agreement.

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

No MRMC comparative effectiveness study was described. The device is an automated in vitro diagnostic (IVD) device for detecting antibodies, not an imaging device requiring human reader interpretation. Therefore, a study to measure human reader improvement with AI assistance is not applicable. The comparison is between the new automated assay and existing commercial laboratory assays (EIA and agglutination tests).

6. Standalone Performance

Yes, a standalone performance study was done. The reproducibility and precision studies evaluate the device's inherent performance characteristics as a standalone assay. The comparative testing also assesses the BioPlex 2200 EBV IgM kit alone against predicate devices, indicating its standalone diagnostic utility. The results (Antibody Index (AI) values, %CV, positive/negative agreement with reference methods) are presented for the BioPlex 2200 system directly.

7. Type of Ground Truth Used

The ground truth used for the comparative studies was:

• Reference Assays: Results from "corresponding commercially available microplate EIA/agglutination tests." These are established diagnostic assays for EBV.
• Serological Pattern Characterization: A generally accepted algorithm for classifying patients into EBV serological status (Table 16) based on results from various EBV antibody tests (including EBV NA-1 IgG, EBV VCA IgG, EBV EA-D IgG, EBV VCA IgM, and Heterophile Antibody).

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML algorithm, as this device appears to be a laboratory immunoassay rather than an AI-driven one. Therefore, there is no concept of a training set for an algorithm in this submission. The panel members for reproducibility and precision studies can be thought of as internal validation sets, but not "training sets" for an AI model.

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

As there is no mention of an AI/ML model or a specific training set with ground truth in the document, this question is not applicable. The characterization of panel members for reproducibility and precision studies would have been established internally by Bio-Rad Laboratories based on known antibody levels or clinical samples.

Ask a specific question about this device

The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of heterophile antibodies to infectious Mononucleosis in whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis infection in adults at 18 years of age and older. They are intended for health professionals including professionals at point-of-care sites.

The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of heterophile antibodies associated with infectious Mononucleosis in whole blood, serum or plasma. They utilize purified IM heterophilic antigen-coated particles and IM heterophilic antigen-coated on the membrane to selectively detect elevated levels of heterophile antibodies to infectious Mononucleosis. These tests can be performed without the use of an instrument.

Here's a breakdown of the acceptance criteria and study information for the ACON® Mononucleosis Rapid Test Strip and Test Device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The acceptance criteria are implicitly based on the device demonstrating substantial equivalence to the predicate device (Genzyme OSOM® Mono Test). The performance metrics provided (positive agreement, negative agreement, overall agreement) are directly compared against the predicate device. The confidence intervals are provided for each agreement calculation.

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Total Test Set Sample Size (Clinical Evaluation): 611 clinical specimens (whole blood, serum, and plasma combined).
   • Breakdown by specimen type:
     • Whole Blood: 131 specimens (51 positive, 80 negative)
     • Plasma: 240 specimens (60 positive, 180 negative)
     • Serum: 240 specimens (73 positive, 167 negative)
   • POL Study Sample Size:
     • Plasma: 180 coded, blinded, and randomized specimens
     • Whole Blood: 180 coded, blinded, and randomized specimens
     • Comparison to trained lab technician: 120 specimens (presumably a subset read by both)
   • Data Provenance: The document does not specify the country of origin of the data, nor whether it was retrospective or prospective. It only mentions "clinical specimens."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number of experts or their qualifications used to establish the "ground truth" (or reference standard) for the clinical specimens against which the ACON test and predicate test were compared.
   • For the POL study, the comparison was made against "expected results" and "those obtained by a trained lab technician," implying an expert or reference method defined the true positive/negative status, but details are not provided.

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

   • The document does not describe an adjudication method for reconciling discrepancies in results. The study compared the ACON device directly against the Genzyme OSOM® Mono Test. Discrepancies between the two tests would contribute to the calculated agreement percentages, but no specific adjudication process for these discrepancies is mentioned.

4. 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:

   • This was not a multi-reader, multi-case (MRMC) comparative effectiveness study with AI assistance. This study evaluates the performance of a rapid diagnostic test (ACON Mononucleosis Rapid Test) against a predicate rapid diagnostic test (Genzyme OSOM® Mono Test). There is no mention of AI or human readers improving with AI assistance.
   • However, a "POL Study Summary" describes evaluating the device's performance when used by personnel at "three distinct sites" (doctors' offices) and compares their results to "expected results" and "those obtained by a trained lab technician." This segment might be considered a form of multi-reader study, but it's not in the context of AI assistance. The "effect size" of improvement is not quantified, but the study showed 98.9% agreement for plasma and 100% agreement for whole blood by POL users compared to expected results, and 100% agreement compared to a trained lab technician (120/120), indicating high accuracy by non-specialized personnel.

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

   • This is a standalone diagnostic test (a lateral flow immunoassay) intended for human interpretation of colored lines. There is no algorithm involved in the test's result generation or interpretation in the way AI would be. The test itself is the "standalone" diagnostic.

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

   • The "ground truth" for the main accuracy study was effectively the results from the Predicate Device, Genzyme OSOM® Mono Test. This is a common approach for demonstrating substantial equivalence for rapid diagnostic tests.
   • For the POL study, the ground truth was referred to as "expected results" and comparisons were made to "those obtained by a trained lab technician." This implies a reference method or expert-derived result was used to determine the true positive/negative status.

7. The sample size for the training set:

   • The document does not mention a training set. This is a traditional immunoassay device, not a machine learning or AI-based device, so the concept of a "training set" for model development does not apply. The clinical evaluation and POL studies are performance validation studies.

8. How the ground truth for the training set was established:

   • As there is no training set for this type of device, this question is not applicable.

Ask a specific question about this device

biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis.

biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis. biorapid Mononucleosis uses the same methodology (immunochromatography test) as the predicate OSOM Mono Test.

The provided text describes the performance of the biorapid Mononucleosis device. There are no explicit "acceptance criteria" presented as specific numerical thresholds that the device must meet in relation to a given ground truth. Instead, the study compares the device's performance against a legally marketed predicate device (OSOM Mono Test) to demonstrate substantial equivalence.

Here's an breakdown based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" (e.g., "The device must achieve >95% sensitivity") are not stated. The performance is reported relative to the predicate device.

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

• Sample Size: A total of 622 specimens.
  • 296 serum samples
  • 261 plasma samples
  • 65 whole blood samples
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It only mentions that the specimens "were evaluated internally and in an external study."

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

This information is not provided. The study uses the OSOM Mono Test (predicate device) as the comparator, implying that the "ground truth" for the performance comparison is the result obtained by the predicate device, not an independent expert consensus or clinical outcome.

4. Adjudication Method for the Test Set

This information is not provided. Given that the comparison is device-to-device rather than device-to-expert ground truth, a formal adjudication method as typically used with human readers is not applicable in the context described.

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 explicitly described in the provided text in the context of human readers improving with or without AI assistance. The study focuses on comparing the new device's performance to a predicate device, not on human reader performance.

6. If a Standalone Study Was Done (Algorithm only without human-in-the-loop performance)

Yes, the performance reported is a standalone evaluation of the biorapid Mononucleosis device compared to the predicate device. The results (positive agreement, negative agreement, overall agreement) reflect the device's intrinsic performance. The reproducibility study also evaluates the device's standalone performance under different user conditions.

7. The Type of Ground Truth Used

The "ground truth" for the primary performance evaluation (agreement study) was the results obtained from the predicate device (OSOM Mono Test). This is a common approach in 510(k) submissions for in vitro diagnostics where substantial equivalence is demonstrated by comparing performance to a legally marketed device.

For the reproducibility study, the "expected results" were used as the ground truth for the three positive and three negative samples. This implies that these samples had a predetermined positive or negative status.

8. The Sample Size for the Training Set

This information is not provided. The document focuses on the performance evaluation of the final device and does not detail any development or training phases. For an immunoassay, the concept of a "training set" in the context of machine learning (AI) is not typically applicable in the same way.

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

This information is not provided, as details about a training set or its ground truth establishment are not mentioned in the context of this immunoassay.

Ask a specific question about this device

Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma. The test aids in the diagnosis of infectious mononucleosis.

Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma.

This document describes the acceptance criteria and study proving the performance of the Color-Monogen device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Sensitivity: 48 samples (presumptively positive for IM heterophile antibodies)
  • Specificity: 200 samples (randomly selected serum patient samples presumptively negative for IM heterophile antibodies)
  • Reproducibility: An in-house IM heterophile antibody calibrator diluted from 1/1 to 1/32, plus Color-Monogen kit controls (negative and positive). The exact number of individual "samples" for reproducibility testing beyond the calibrator dilutions and controls isn't specified, but it was tested by three operators on five consecutive days.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "samples" and "serum patient samples."

3. Number of Experts and Qualifications for Ground Truth

• The study design does not indicate the use of experts to establish ground truth for the test set. Instead, it uses a commercially available horse red cell slide test as the reference method for comparison to determine sensitivity and specificity.

4. Adjudication Method

• No adjudication method (e.g., 2+1, 3+1, none) for the test set is described, as the ground truth was established by comparison to a predicate device, not by expert consensus.

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

• A MRMC comparative effectiveness study was not conducted. The study focuses on the device's performance against a predicate device, not on human reader performance with or without AI assistance.
• For reproducibility, three different operators tested the samples for 5 consecutive days, but this was to assess the device's consistency, not to compare human reader performance with or without AI.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The reported sensitivity, specificity, and reproducibility figures represent the Color-Monogen device's performance directly, independent of human interpretation or assistance beyond following the test procedure.

7. Type of Ground Truth Used

• The ground truth for sensitivity and specificity was established by comparing the Color-Monogen device's results to a commercially available horse red cell slide test. For reproducibility, an in-house IM heterophile antibody calibrator and Color-Monogen kit controls served as the reference.

8. Sample Size for the Training Set

• No information is provided about a training set. This device is a diagnostic test kit (direct hemagglutination) and likely does not involve machine learning or an algorithm that requires a separate training set.

9. How Ground Truth for Training Set Was Established

• Not applicable, as no training set is mentioned or implied for this type of device.

Ask a specific question about this device

The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician's office laboratory and the clinical laboratory.

Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen using mouse monoclonal anti-IgM antibodies and heterophile antigen from bovine red blood cells.

Here's an analysis of the provided text regarding the Genzyme Diagnostics Contrast® Mono test, structured according to your request:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: 480 specimens (serum, plasma, and whole blood)
• Data Provenance: Retrospective (specimens submitted for infectious mononucleosis testing) and prospective (students presenting with symptoms) from a multicenter clinical study. The study was conducted in three physician's office laboratories (POLs), including two university student health centers and one clinical laboratory. The country of origin is not explicitly stated.

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

The text states that the Genzyme device was compared to the "reference method" and the legally marketed "Quidel Concise® Plus™ Mono Test." The predicate device likely served as the de facto "ground truth" or a strong proxy for it. There is no information provided about the number of experts or their qualifications used to establish this reference method or to adjudicate the results of the Quidel test itself for the purpose of this study.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "reference method" or the predicate device's results were used for comparison. It's implied that the results of these reference methods were taken as authoritative.

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 reported. The study focused on the agreement of the novel device with a predicate device, not on how human readers' performance improved with or without AI assistance.

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

Yes, this was a standalone performance study. The Genzyme Diagnostics Contrast® Mono Test is a rapid immunoassay kit. Its performance was evaluated by comparing its direct results to those of a reference method/predicate device. There is no "human-in-the-loop" aspect to the device's output itself.

7. The Type of Ground Truth Used

The ground truth was established by comparing the test device's results to a legally marketed predicate device (Quidel Concise® Plus™ Mono Test) and a "reference method." While the nature of the "reference method" isn't explicitly detailed, in the context of IVD devices like this, it typically refers to a well-established and accepted diagnostic procedure for the disease.

8. The Sample Size for the Training Set

This information is not provided. The document describes a clinical study to evaluate the device's performance, but it does not detail any separate training set or process for developing the immunoassay itself.

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

This information is not provided, as details about a specific "training set" for the device's development are absent from the document. The immunoassay itself would have been developed based on scientific principles and internal validation, but the documentation focuses on the external clinical validation study.

Ask a specific question about this device