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510(k) Data Aggregation
(155 days)
CLARK LABORATORIES, INC.
The Viral Capsid Antigen (VCA) IgM kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgM antibodies in human serum to VCA antigen. The Clark anti-VCA IgM assay may be used in conjunction with other Epstein-Barr serologies (EA-D IgG, VCA IgG, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis in the adult population.
The Wampole Epstein-Barr Viral Capsid Antigen (VCA) IgM kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgM antibodies in human serum to VCA antigen. The Wampole anti-VCA IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, EBNA-1 IgG, EA-D IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only. The VCA IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Epstein-Barr Viral Capsid antigen. Afinity purified gp125 VCA antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
Here's a breakdown of the acceptance criteria and the study details for the Wampole VCA IgM ELISA Test Kit, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the Wampole VCA IgM ELISA Test Kit are based on its performance in terms of sensitivity and specificity, as demonstrated by the serum characterization study.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | High relative sensitivity for acute EBV cases | 97.4% (95% CI: 92.2%-100%) for Acute cases |
| Specificity (Seronegative) | High relative specificity for seronegative individuals | 96.4% (95% CI: 89.4%-100%) for Seronegative cases |
| Specificity (Seropositive) | High relative specificity for seropositive individuals | 99.0% (95% CI: 97.0%-100%) for Seropositive cases |
| Overall Agreement | High overall agreement with serological characterization | 98.2% (95% CI: 96.1%-100%) |
| Cross-Reactivity | No cross-reactivity with common interfering antibodies (HSV, CMV, VZV, RF) | Demonstrated no cross-reactivity (all VCA IgM results were negative, while alternate assays were positive) |
Note: The document does not explicitly state numerical acceptance thresholds (e.g., "sensitivity must be >95%"). Instead, the reported performance metrics serve as the basis for demonstrating substantial equivalence to the predicate device.
Study Details
1. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 166 selected serum samples.
- Data Provenance: The text states, "One hundred and sixty six selected serum were tested at a clinical lab." This suggests the data is retrospective, as the serum samples were "selected" and "characterized," implying they were already collected and categorized before the study. The country of origin is not specified, but the submission is to the U.S. FDA, so it's likely U.S.-based or from a region with similar clinical practices.
2. 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 or qualifications of experts used to establish the ground truth. The ground truth ("seronegative," "acute," or "seropositive" EBV infection) was established based on a panel of other Epstein-Barr serologies (VCA IgM, heterophile antibody, EBNA IgG, VCA IgG). It is implied that these serological profiles, rather than individual expert opinions, served as the basis for characterization.
3. Adjudication Method for the Test Set
The document does not detail an adjudication method. The characterization of serum samples (acute, seropositive, seronegative) was based on the presence or absence of specific markers from a panel of EBV serologies. It's an objective classification based on laboratory results, not subjective interpretation requiring adjudication.
4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not reported. This study evaluates an in vitro diagnostic device (ELISA kit), not an AI system or imaging device where human reader performance would be a primary metric.
5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study represents a standalone performance evaluation of the Wampole VCA IgM ELISA Test Kit. The test kit itself is the "algorithm" or device being evaluated, and its performance (sensitivity, specificity, precision, cross-reactivity) is assessed directly against the established ground truth of the serum samples. There is no human-in-the-loop interaction being measured for diagnostic performance, other than the standard laboratory procedures for running the assay.
6. The Type of Ground Truth Used
The ground truth used was expert serological characterization. This was based on a panel of established serological markers for Epstein-Barr Virus infection:
- Acute: VCA IgM present, EBNA IgG absent, Heterophile antibody present.
- Seropositive (Past infection): VCA IgG present, EBNA IgG present, VCA IgM absent, Heterophile antibody absent.
- Seronegative: VCA IgG absent, EBNA IgG absent, VCA IgM absent, Heterophile antibody absent.
This method relies on established clinical and laboratory diagnostic criteria to define the true state of EBV infection for each sample.
7. The Sample Size for the Training Set
The document does not report a separate training set or its sample size. This type of diagnostic device (ELISA kit) typically undergoes development and optimization before an official performance study. The data presented here is for the validation/test phase of the device.
8. How the Ground Truth for the Training Set Was Established
As no specific training set is reported, the method for establishing its ground truth is also not mentioned. For the development and optimization of such assays, manufacturers generally use well-characterized clinical samples or panels from reference laboratories.
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(134 days)
CLARK LABORATORIES, INC.
The Viral Capsid Antigen (VCA) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to VCA antigen. The Clark anti-VCA IgG assay may be used in conjunction with other Epstein-Barr serologies (EA-D IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis in a adult population.
The Epstein-Barr Viral Capsid Antigen (VCA) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to VCA antigen. The Clark anti-VCA IgG assay may be used in conjunction with other Epstein-Barr serologies (EA-D IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only. The VCA IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Epstein-Barr Viral Capsid Antigen. Purified recombinant VCA antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
Here's a breakdown of the acceptance criteria and study details for the VCA IgG ELISA Test Kit, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the different performance metrics. However, we can infer the reported performance as the outcome of the evaluation.
| Performance Characteristic | Reported Device Performance |
|---|---|
| Sensitivity | |
| Relative Sensitivity (Acute) | 58.8% (95% CI: 41.9%-75.7%) |
| Relative Sensitivity (Seropositive) | 95.0% (95% CI: 90.5%-99.4%) |
| Specificity | |
| Relative Specificity (Seronegative) | 100% (95% CI: 89.0%-100%) |
| Agreement | |
| Relative Agreement | 87.5% (95% CI: 82.3%-92.7%) |
| Precision | (Coefficient of Variation (CV) |
| Serum 1 | 7.80% |
| Serum 2 | 11.33% |
| Serum 3 | 8.33% |
| Serum 4 | 13.32% |
| Serum 5 | 23.48% |
| Serum 6 | 26.16% |
| HP (High Positive) | 9.19% |
| Cal (Calibrator) | 5.99% |
| LP (Low Positive) | 13.92% |
| NC (Negative Control) | 105.88% |
| Cross-Reactivity | No cross-reactivity observed with Herpes Simplex Virus I & II, Cytomegalovirus, and Varicella Zoster Virus IgG antibodies (all VCA IgG results ≤ 0.61 for these sera, with negative threshold ≤ 0.90). |
2. Sample size used for the test set and the data provenance
- Sample Size (Sensitivity and Specificity study): 166 selected serum samples.
- 39 samples characterized as Acute
- 99 samples characterized as Seropositive
- 28 samples characterized as Seronegative
- Data Provenance: The serums were "tested at a clinical lab." The origin country is not specified, but the context of the submission to the FDA suggests the data is likely from the United States or intended for the US market. The study is retrospective, as the serum samples were "selected" and "characterized" prior to testing with the VCA IgG ELISA kit.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth was established by "characteriz[ing]" the serum samples as "seronegative," "acute," or "seropositive" based on other Epstein-Barr virus (EBV) serologies (VCA IgM, EBNA IgG, heterophile antibody).
- Number of experts: Not explicitly stated. The characterization appears to be based on the results of other EBV serology tests, rather than direct expert interpretation of the VCA IgG ELISA results themselves. It's implied that clinical laboratory professionals would interpret these other serology results to categorize the samples.
- Qualifications of experts: Not specified, but implied to be individuals competent in interpreting EBV serology results, such as clinical laboratory scientists or physicians.
4. Adjudication method for the test set
The document does not describe an adjudication method for the test set. The categorization of serum samples into "acute," "seropositive," and "seronegative" was based on a panel of other EBV serology tests, and then the VCA IgG ELISA test result was compared to this established classification. Equivocal results from the VCA IgG ELISA were not retested or adjudicated; they were simply excluded from the sensitivity and specificity calculations.
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
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) ELISA test kit, not an AI-powered image analysis or diagnostic tool that involves human "readers" in the context of interpretation. Therefore, a study on human reader improvement with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The entire performance characteristic section (sensitivity, specificity, precision, cross-reactivity) evaluates the VCA IgG ELISA device on its own, independent of human interpretation or assistance beyond the standard laboratory procedures for running the assay and reading the photometric results. The "human-in-the-loop" here is the lab technician conducting the test and reading the quantifiable outcome, not interpreting complex images or clinical scenarios that would typically involve an AI algorithm.
7. The type of ground truth used
The ground truth used was "serological characterization" based on a panel of established EBV serology tests (VCA IgM, EBNA IgG, heterophile antibody). This is a form of reference standard test result.
8. The sample size for the training set
- Not applicable. The provided text describes a traditional ELISA diagnostic kit. There is no mention of a "training set" as would be used for machine learning or AI models. The development of such a kit typically involves assay optimization and validation during its development, but not in the sense of a machine learning training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
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(73 days)
CLARK LABORATORIES, INC.
The Epstein Barr Nuclear Antigen 1 (EBNA-1) IgM kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen. The Clark anti-EBNA-1 IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis in adult populations.
The Wampole Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgM kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen. The Wampole anti-EBNA-1 IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis.
For In Vitro Diagnostic Use Only.
The EBNA-1 IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Epstein-Barr Nuclear Antigen -1. Recombinant EBNA-1 antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
Here's an analysis of the provided information regarding the EBNA-1 IgM ELISA Test Kit, presented with the requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in the provided text. However, based on the presented performance characteristics, we can infer the implied targets for sensitivity and specificity. The study demonstrates performance against these inferred criteria.
| Performance Metric | Implied Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Sensitivity | High for acute cases (target > ~50%) | 51.4% (95% CI: 34.9%-67.8%) |
| Specificity (Seronegative) | High (target = 100%) | 100% (95% CI: 89.4%-100%) |
| Specificity (Seropositive) | High (target > ~90%) | 94.5% (95% CI: 89.7%-99.3%) |
| Relative Agreement | High (target > ~80%) | 85.3% (95% CI: 79.6%-90.9%) |
| Precision (Inter-Site CV) | Low variability (e.g., |
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(218 days)
CLARK LABORATORIES, INC.
The . Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.
Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked The Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. The EA-D IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Epstein-Barr Early Antigen Diffuse component. Purified recombinant EA-D antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
Here's an analysis of the provided text to extract the acceptance criteria and study information:
Acceptance Criteria and Device Performance for EA-D IgG ELISA Test Kit
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied/Derived) | Reported Device Performance |
|---|---|---|
| Sensitivity (Late Acute) | High (e.g., >95%) | 100% (95% CI: 67.9%-100%) |
| Specificity (Seronegative) | High (e.g., >95%) | 100% (95% CI: 79.1%-100%) |
| Specificity (Early Acute) | High (e.g., >90%) | 97.0% (95% CI: 91.0%-100%) |
| Sensitivity (Seropositive) | Not explicitly defined as a target for "sensitivity" in this context, but rather an expected low positive rate. | 19.7% (95% CI: 12.8%-26.6%) |
| Specificity (Seropositive) | High (e.g., >70-80%) | 80.3% (95% CI: 73.4%-87.2%) |
| Overall Relative Agreement | High (e.g., >80%) | 85.6% (95% CI: 80.5%-90.8%) |
| Precision (Coefficient of Variation - CV) | Low (e.g., |
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