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The SeraQuest EBV EA-D IgG test is for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum by enzyme immunoassay. This assay uses a 28 kd E. coli expressed recombinant Epstein-Barr virus early antigen. When performed in conjunction with other EBV serological tests, this assay can be used as an aid in the laboratory diagnosis of EBV infectious mononucleosis in patients with signs and symptoms of EBV infectious mononucleosis. For In Vitro Diagnostic Use Only.

The SeraQuest EBV EA-D IgG Test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against EBV Early Antigen D (EA-D), in human serum.

The document describes the SeraQuest EBV EA-D IgG Test, a solid-phase enzyme immunoassay (EIA) designed for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum. This assay aids in the laboratory diagnosis of EBV infectious mononucleosis when used with other EBV serological tests.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., "Positive Agreement must be >X%"). Instead, it presents various performance metrics derived from its clinical evaluation, which are then compared to a legally marketed predicate device. The implicit acceptance criterion appears to be "substantial equivalence" to the predicate device in terms of performance characteristics for diagnostic aid in EBV infectious mononucleosis.

The performance is reported in terms of percent agreement and associated confidence intervals, categorized by EBV serological status.

Note: For comparison, the predicate device (Comparator EBV EA-D IgG Test) achieved:

• Acute Infection Positive Agreement: 41.9% (13/31) with CI 24.5-60.9% (prospectively tested)
• Acute Infection Positive Agreement: 64.0% (32/50) with CI 49.2-77.1% (retrospectively tested)
• EBV Seronegative Negative Agreement: 78.3% (47/60) with CI 65.8-87.9% (prospectively tested)
• No Infection Negative Agreement: 73.3% (11/15) with CI 44.9-92.2% (retrospectively tested)
• Past Infection Negative Agreement: 62.7% (195/311) with CI 57.3-68.1% (prospectively tested)

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

• Total Test Set Sample Size: 542 serum samples.
  • Prospectively Collected and Prospectively Tested: 477 samples.
  • Prospectively Collected but Retrospectively Tested: 65 samples (50 acute specimens, 15 EBV seronegative).
• Data Provenance:
  • Country of Origin: 3 U.S. clinical testing sites.
  • Nature of Data: Mixed; primarily prospective (477 samples) with a supplementary retrospective component (65 samples that were prospectively collected but retrospectively tested). The study notes that the 65 specimens were retrospectively tested to "supplement the prospective study data."

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

The document states that specimens were classified into EBV serological states (Acute, EBV seronegative, Past Infection, Indeterminate) "as determined by other EBV serological reagents" and "reference EBV serology assays for EBV VCA IgG, EBV VCA IgM, and EBV EBNA-1 IgG." It does not mention the use of human "experts" or their qualifications to establish the ground truth for the test set. The ground truth was established by the results of established reference serological assays.

4. Adjudication Method for the Test Set

The document does not describe an "adjudication method" in the traditional sense involving human review of discrepancies. Instead, it details how equivocal results from both the SeraQuest test and the comparator test were handled for percent agreement calculations:

• "SeraQuest EBV EA-D IgG test equivocal results were assigned to the opposite test result interpretation than that of the corresponding comparative test results."
• "Likewise, the comparative test equivocal results were assigned to the opposite test result interpretation than that of the corresponding SeraQuest EBV EA-D IgG Test results."
  This is a statistical adjustment for calculation rather than clinical adjudication by 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

This section is not applicable to this device. The SeraQuest EBV EA-D IgG Test is an in vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers" or "AI assistance." The "comparator" in this study refers to another commercially available EBV EA-D IgG ELISA test, not human readers or an AI system.

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

This section is applicable as the SeraQuest EBV EA-D IgG Test is an immunoassay that operates independently to produce a result. Its performance was evaluated in a standalone manner by comparing its output (positive, negative, equivocal) to the serological classification derived from reference EBV serology assays. The results presented in Tables 6 and 7 directly reflect the standalone performance of the SeraQuest test relative to the established EBV serological classification.

7. The Type of Ground Truth Used

The ground truth for classifying specimens into EBV serological states (Acute, EBV seronegative, Past Infection, Indeterminate) was established using a combination of results from reference EBV serology assays: EBV VCA IgG, EBV VCA IgM, and EBV EBNA-1 IgG. This can be categorized as serological reference assay data. The document explicitly states: "The EBV EA-D IgG result generated by the commercially available comparator EBV EA-D IgG ELISA test was not considered for purposes of characterizing the EBV serological state of the specimen."

8. The Sample Size for the Training Set

The document does not mention a "training set." This device is an immunoassay kit, not a machine learning or AI algorithm that requires a training set in the typical sense. The studies described are for clinical performance validation, not for training a model.

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

Since there is no mention of a "training set" in the context of this immunoassay, this question is not applicable. The "ground truth" for the performance evaluation (test set) was established using reference EBV serology assays, as described in point 7.

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• 1. For In Vitro Diagnostic Use
• 2. For the qualitative and semi-quantitative detection of human IgG antibodies to Epstein-Barr (EB) viral capsid antigen (VCA) in human serum by enzyme immunoassay.
• 3. For use as an aid in differentiating active or recent infection, from past infection.

The SeraQuest EB VCA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum. The Calibrators in the SeraQuest EB VCA IgG test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

Acceptance Criteria and Device Performance Study for SeraQuest EB VCA IgG

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for the SeraQuest EB VCA IgG device. Instead, it presents results and compares them to a predicate device. Based on the "Overall agreement" calculated, we infer that an agreement level with the predicate device was the primary metric of performance.

*Excluding equivocal results.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 113 serum samples.
• Data Provenance: Not explicitly stated, but the study compares the SeraQuest device to a predicate device (Zeus EBV VCA IgG) using "serum samples." The document is from a US regulatory submission, suggesting the data may be from the US, but this is not confirmed. The data appears to be retrospective as it compares the new device's performance against existing results from another test.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not applicable. The ground truth for this study was established using a predicate device's results, not expert interpretation of samples.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. The comparison was directly against the results of the predicate device (Zeus EBV VCA IgG), not against a consensus of human readers.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the new device to a predicate device, not to human readers with and without AI assistance.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone performance study was conducted. The SeraQuest EB VCA IgG device's performance (specifically its agreement with the predicate device) was evaluated independently. The table detailing the "Results of SeraQuest VCA IgG Assays (Modified Device) and Zeus VCA IgG Assays on 113 Serum Samples" directly shows the device's output against the predicate device's output.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by the results of a predicate device (Zeus EBV VCA IgG Test System). The predicate device's results were used as the reference against which the SeraQuest device's performance was measured.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. This device is a diagnostic assay (solid-phase enzyme immunoassay, EIA), not an AI/machine learning algorithm that requires a training set in the conventional sense. The "training" or development of such a device involves chemical and biological optimization, not data-driven model training.

9. How Ground Truth for Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable, as it's not an AI/machine learning device with a training set. The development of the assay would have involved standard laboratory methods and internal validation to optimize its components and ensure it accurately detects IgG antibodies to Epstein-Barr virus capsid antigen.

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For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For in vitro diagnostic use only.

The SeraQuest VCA IgM test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgM antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum.

The Calibrators in the SeraQuest VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

Here's a breakdown of the acceptance criteria and study details for the SeraQuest® VCA IgM device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria for the SeraQuest® VCA IgM device beyond the 'Overall agreement' percentage. It primarily demonstrates substantial equivalence to a predicate device using comparative clinical testing.

Table 1. SeraQuest® VCA IgM Performance Against Zeus' EBV-VCA IgM EIA Test

Note: The acceptance criteria here are inferred from the reported overall agreement, as no specific quantitative thresholds were explicitly defined in the document for FDA clearance.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 113 specimens
   • Data Provenance: Archival patient specimens tested at SeraQuest, Miami, FL (United States). The study is retrospective.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • The document does not specify the number of experts or their qualifications used to establish the ground truth. Instead, the predicate device (Zeus' EBV-VCA IgM ELISA test) served as the comparator for the test set.

3. Adjudication Method:

   • The document does not describe a specific adjudication method such as 2+1 or 3+1. The results of the SeraQuest test were directly compared against the results of the Zeus' EBV-VCA IgM ELISA test.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not conducted. This study is a comparison of a new diagnostic device against a predicate device, not a study of human reader improvement with or without AI assistance.

5. Standalone Performance Study:

   • Yes, a standalone performance study was conducted. The SeraQuest VCA IgM device's performance was evaluated by testing 113 archival patient specimens and comparing its results directly with those obtained from the predicate device (Zeus' EBV-VCA IgM ELISA test). This represents the algorithm/device's performance without human intervention in the result interpretation beyond what is inherent in reading an EIA test.

6. Type of Ground Truth Used:

   • The "ground truth" for this study was established by the results obtained from the predicate device, Zeus' EBV-VCA IgM ELISA test. This is a comparative study where the predicate device's results serve as the reference.

7. Sample Size for the Training Set:

   • The document does not provide information on a training set or its sample size. As this is a diagnostic device comparison for substantial equivalence, it's likely a fully developed product was tested, not one undergoing a machine learning training phase.

8. How the Ground Truth for the Training Set was Established:

   • Since no training set information is provided, the method for establishing its ground truth is also not available.

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For the quantitative detection of IqG antibodies to thyroid peroxidase in human serum by enzyme immunoassay. The SeraQuest Anti-thyroid peroxidase test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease. For in vitro diagnostic use only.

The SeraQuest Anti-Thyroid Peroxidase test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minutes incubations. It has been developed to detect IgG antibodies which are directed against Thyroid Peroxidase, in human serum. The Calibrators in the SeraQuest Anti-Thyroid Peroxidase test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).

Here's a breakdown of the acceptance criteria and the study details for the SeraQuest® Anti-Thyroid Peroxidase device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather presents a clinical study comparing the new device (SeraQuest) against a predicate device (Varelisa TPO Antibodies test). The performance metrics of the SeraQuest device against the predicate are what would typically be used to demonstrate equivalence for regulatory acceptance.

Note: The document states, "The SeraQuest Anti-Thyroid Peroxidase test is substantially equivalent in intended use and performance, to the Pharmcia Varelisa TPO Antibodies, Freiburg, Germany." This indicates that the performance of the predicate device serves as the implicit acceptance criteria for the new device.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 141 serum specimens.
• Data Provenance: The study was conducted at Quest International, Inc., implying the data was collected or processed within the United States. The retrospective or prospective nature of the sample collection is not explicitly stated, but the specimens were "tested concurrently" by both devices, suggesting a prospective application to existing samples or a concurrent collection setup.

3. Number and Qualifications of Experts for Ground Truth

• The document does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., a panel of radiologists for imaging).
• Instead, the "ground truth" for the performance evaluation was established by comparing the SeraQuest device's results against a legally marketed predicate device, the Pharmacia Varelisa TPO Antibodies test. The predicate device itself acts as the reference standard.

4. Adjudication Method for the Test Set

• No explicit adjudication method (like 2+1, 3+1) is described for the test set.
• The comparison was a direct concurrent testing of each specimen by both the SeraQuest device and the Varelisa TPO Antibodies test, with results compared qualitatively (positive, equivocal, negative). For discordant results, one specimen was re-tested using a second legally marketed device (Scimedix Anti-Thyroid Peroxidase Test) to help resolve the discrepancy, but this wasn't a systematic adjudication process for all disagreements.

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

• No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) test, not an imaging AI tool requiring human reader interpretation or assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done in the sense that the SeraQuest device's results were independently generated for each specimen and then compared to the predicate. The performance metrics (sensitivity, specificity, agreement) directly reflect the algorithm's (or device's) standalone diagnostic capabilities relative to the predicate. There is no human-in-the-loop component for these specific performance metrics.

7. Type of Ground Truth Used

• The ground truth used was the results obtained from a legally marketed predicate device (Pharmacia Varelisa TPO Antibodies test). For one discordant case, a second legally marketed device (Scimedix Anti-Thyroid Peroxidase Test) was used as an additional reference. This is a form of comparative ground truth against an established, similar diagnostic method.

8. Sample Size for the Training Set

• The document does not provide information on a training set or its sample size. This is typical for IVD assay submissions where the focus is on analytical and clinical performance against a reference method rather than AI algorithm training.

9. How Ground Truth for the Training Set Was Established

• Since no training set is mentioned, information on how its ground truth was established is not provided.

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1. For the quantitative detection of IqG antibodies to thyroglobulin in human serum by enzyme immunoassay.
2. The SeraQuest Anti-thyroglobulin test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease.
3. For in vitro diagnostic use only.

The SeraQuest Anti-Thyroglobulin test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IqG antibodies which are directed against thyroglobulin, in human serum.

The Calibrators in the SeraQuest Anti-Thyroglobulin test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).

This document describes the validation study for the SeraQuest Anti-Thyroglobulin test.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: 144 serum specimens.
• Data Provenance: The study was conducted at Quest International, Inc., and the specimens were "serum specimens," implying human origin. The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for device clearance, it is generally assumed to be a prospective or at least properly collected retrospective dataset for regulatory purposes.

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

• This study did not use human experts to establish ground truth. Instead, it used a predicate device (Pharmacia Varelisa TG Antibodies test) as the reference standard. The performance of the SeraQuest Anti-Thyroglobulin test was compared directly to this established and legally marketed device.

4. Adjudication Method for the Test Set:

• No adjudication method by human experts was used for the test set. The comparison was directly against the results of the predicate device. When a discordant result occurred between the SeraQuest and Varelisa tests (1 specimen), it was further tested by a second legally marketed device, the Scimedix Anti-Thyroglobulin Test. This serves as a form of secondary verification rather than adjudication by expert consensus.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is an in-vitro diagnostic device comparison, not an imaging or clinical diagnostic aid that typically involves human readers.

6. Standalone (Algorithm Only) Performance Study:

• Yes, a standalone performance study was done. The SeraQuest Anti-Thyroglobulin test (the algorithm/device) was run independently on the 144 serum specimens, and its results were then compared to the results obtained from the predicate device (Pharmacia Varelisa TG Antibodies test), which also operated in a "standalone" fashion.

7. Type of Ground Truth Used:

• The "ground truth" used in this study was the results obtained from a legally marketed predicate device (Pharmacia Varelisa TG Antibodies test). This is a common approach for demonstrating substantial equivalence for in-vitro diagnostic devices. For the one discordant specimen, a second legally marketed device (Scimedix Anti-Thyroglobulin Test) was used for further verification, which gave an equivocal result.

8. Sample Size for the Training Set:

• The document does not explicitly state the sample size used for a "training set." This type of in-vitro diagnostic device likely undergoes development and internal validation and optimization with various samples, but the FDA submission focuses on the validation against a predicate device using a specific test set. The 144 specimens were for the performance study, not explicitly described as a training set.

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

• As a training set is not explicitly described or quantified, the method for establishing its ground truth is not provided. However, for the development and optimization of such an assay, ground truth would typically be established through a combination of well-characterized clinical samples (e.g., from patients with confirmed autoimmune thyroiditis or Graves' disease, and healthy controls), using reference methods or established clinical diagnoses.

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For in vitro diagnostic use only.
For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr virus nuclear antigen in human serum by enzyme immunoassay.
May be used in conjunction with other EBV serologicals as an aid in the diagnosis of infectious mononucleosis.

The SeraQuest EB NA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Epstein-Barr virus nuclear antigen, in human serum.

The Calibrators in the SeraQuest EB NA IgG test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

Here's an analysis of the provided text regarding the SeraQuest® EB NA IgG device, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SeraQuest EB NA IgG test were established relative to the predicate device, Gull Laboratories' EBNA IgG ELISA test. The performance metrics are reported as relative sensitivity, relative specificity, and overall agreement.

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

• Sample Size: 157 archival serum specimens.
• Data Provenance: The specimens included:
  • 80 from patients whose sera were submitted to a clinical laboratory for EBV serological testing.
  • 11 from donors reported to be positive for EBV antibodies, obtained through serum brokers.
  • 66 from normal serum donors.
  • The term "archival serum specimens" suggests a retrospective nature for the study. The country of origin is not explicitly stated, but the applicant (Quest International, Inc.) is based in North Miami, FL, USA.

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

The ground truth for the test set was established by the predicate device, the Gull Laboratories' EBNA IgG test. Therefore, no human experts were explicitly used to establish ground truth in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. The study compared the new device (SeraQuest EB NA IgG) directly against a predicate device (Gull Laboratories' EBNA IgG test). There was no adjudication process involving multiple human readers to resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study compares a new in-vitro diagnostic device to a predicate in-vitro diagnostic device, not human readers with and without AI assistance.

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

Yes, a standalone performance study was done. The SeraQuest EB NA IgG test is an in-vitro diagnostic kit and its performance was evaluated directly without human interpretation as part of the primary outcome measure, other than following manufacturers' instructions.

7. The Type of Ground Truth Used

The ground truth for this comparison study was established by the performance of the predicate device, the Gull Laboratories' EBNA IgG ELISA test.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this submission. The SeraQuest EB NA IgG test is a laboratory kit, not an AI/machine learning algorithm requiring a training dataset. The submission focuses on the analytical and clinical performance of the manufactured kit.

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

Not applicable, as there was no training set.

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1. For in vitro diagnostic use only.
2. For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr viral capsid antigen (VCA) in human serum by enzyme immunoassay.
3. For use as an aid in differentiating active or recent infection, from past infection.
4. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

The SeraQuest EB VCA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Epstein-Barr virus capsid antigen.

The provided text describes the SeraQuest EB VCA IgG test, an Enzyme Immunoassay (EIA) for detecting IgG antibodies to Epstein-Barr virus capsid antigen (VCA) in human serum. The primary study presented aims to demonstrate substantial equivalence to a predicate device, the Gull Laboratories' EBV IgG ELISA test.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for sensitivity, specificity, or overall agreement. Instead, it presents the device's performance in comparison to a predicate device and implicitly uses these results to support substantial equivalence. The predicate device's performance is not exhaustively detailed, but the comparison implies that the SeraQuest EB VCA IgG test should perform comparably.

*Excluding equivocal results.

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

• Sample Size: 157 specimens.
• Data Provenance: The study was "performed in-house at Quest International, Inc., Miami, FL." The country of origin of the samples is not specified, but the testing location is in the USA. The design is retrospective, as existing specimens were "tested" with both devices.

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

The study uses the Gull Laboratories' EBV IgG ELISA test as the comparator or "reference" for evaluating the SeraQuest device's performance, not an expert panel. Therefore, no information on the number or qualifications of experts used to establish a separate "ground truth" is provided. The Gull test essentially acts as the 'ground truth' in this comparative study for regulatory purposes.

4. Adjudication Method for the Test Set

No explicit adjudication method is described. The comparison is straightforward: results from the SeraQuest test are compared directly against results from the Gull Laboratories' test. Where discrepancies occurred (e.g., equivocal results), they are reported, but no further expert adjudication process is detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of an in vitro diagnostic (IVD) device, specifically a serological assay, which typically does not involve human readers interpreting images or data in a way that an MRMC study would assess.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this was a standalone study. The SeraQuest EB VCA IgG test is an enzyme immunoassay designed for qualitative and semi-quantitative detection of antibodies. The results are generated by the assay process itself, and its performance (sensitivity, specificity, agreement) is reported solely based on its output compared to the predicate device. There is no human interpretation or intervention in the algorithm's performance being assessed.

7. Type of Ground Truth Used

The "ground truth" for this study was established by the predicate device, the Gull Laboratories' EBV IgG ELISA test. The study aims to show substantial equivalence, meaning the SeraQuest device's results align closely with those obtained from the already legally marketed Gull test. There is no mention of pathology, clinical outcomes data, or expert consensus being used as a separate, independent ground truth.

8. Sample Size for the Training Set

The document does not mention a "training set" or "validation set" in the context of machine learning, as this device is a traditional immunoassay. Therefore, this question is not applicable based on the provided text. The numbers given (157 specimens) refer to the clinical evaluation or test set.

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

As there is no mention of a training set, the method for establishing its "ground truth" is not applicable based on the provided text.

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1. For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection.
2. For in vitro diagnostic use only.
3. A positive result is presumptive for the detection of anti-Epstein-Barr virus IgM antibodies and presumptive for the diagnosis of acute or recent Epstein-Barr virus infection.

The SeraQuest EB VCA IgM test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgM antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum.

The Calibrators in the SeraQuest EB VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

The provided document describes the SeraQuest EB VCA IgM test, an enzyme immunoassay designed to detect IgM antibodies to Epstein-Barr virus capsid antigen in human serum. This diagnostic test aims to differentiate active or recent EBV infection from past infection.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of sensitivity, specificity, or positive/negative predictive values. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device by comparing overall agreement.

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

• Sample Size: 157 specimens.
• Data Provenance: "Archival Patient Specimens Tested at SeraQuest, Miami, FL". This indicates the data is retrospective and from the USA (Miami, FL).

3. 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 of experts used or their qualifications to establish the ground truth for the test set. The comparison is made against a predicate device (Gull Laboratories' EBV IgM ELISA), which acts as the reference for classification (positive, negative, equivocal).

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method involving multiple readers or experts to resolve discrepancies between the SeraQuest test and the predicate device. The results are presented as a direct comparison between the two tests.

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 conducted or reported for this device. The study is a direct comparison of the new device's performance against a predicate device, not an evaluation of human reader improvement with or without AI assistance.

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

Yes, the study describes the standalone performance of the SeraQuest EB VCA IgM test. As an enzyme immunoassay, it produces a quantitative result (Index value) which is then interpreted qualitatively (positive, negative, equivocal) without direct human-in-the-loop performance during the result generation. The comparison is between the standalone performance of the new device and the standalone performance of the predicate device.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate device, Gull Laboratories' EBV IgM ELISA test. The study evaluates the concordance of the SeraQuest test with this predicate rather than an independent, gold-standard ground truth like pathology or long-term clinical outcomes.

8. The Sample Size for the Training Set

The document does not specify a separate training set size. The 157 specimens are referred to as "archival patient specimens" used for the comparison study. As this is an immunoassay and not a machine learning algorithm in the modern sense that requires explicit "training," the concept of a separate training set is not directly applicable in the terms usually associated with AI/ML development. The "in-house standard" mentioned for assigning Index values to calibrators might involve some internal standardization, but it's not a training set in the context of supervised learning.

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

Given that a training set in the AI/ML context is not explicitly mentioned or relevant, the method for establishing its ground truth is not applicable here. The test performance is evaluated against the predicate device.

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• For the qualitative detection of IgM antibodies to CMV in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection.
• A positive result is presumptive for the detection of anti-CMV antibodies and presumptive for the diagnosis of acute or recent CMV infection.
• Useful for the above indications, with specimens obtained from women of childbearing age.
• For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the SeraQuest CMV IgM device, which primarily concerns the substantial equivalence determination to a legally marketed predicate device.

The document discusses:

• The FDA's review and determination of substantial equivalence for the SeraQuest CMV IgM device.
• Regulatory classifications and general controls applicable to the device.
• CLIA complexity categorization.
• Contact information for various FDA offices.
• The intended uses (indications for use) of the device.

There is no mention of specific performance metrics, acceptance criteria, study design, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies as requested in your prompt.

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