Search Results

Ask a specific question about this device

The Mono G Test is a qualitative enzyme immunoassay (EIA) that detects IgG antibodies to Epstein-Barr virus capsid antigen (EBV-VCA), Epstein-Barr early nuclear antigen (EBV-EBNA), cytomegalovirus (CMV), and toxoplasma (toxo). When used in conjunction with Mono-M Test it is an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV or toxoplasma mononucleosis-like syndrome.

This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).

The product is an ELISA test method detecting viral capsid antigen Epstein-Barr nuclear antigen, cytomegalovirus and toxoplasma IgG antibodies.

Here's an analysis of the provided 510(k) summary, extracting the requested information about acceptance criteria and the supporting study:

The provided document describes the ImmunoDOT Mono G Test, an ELISA method for detecting IgG antibodies related to mononucleosis. The "acceptance criteria" in this context refer to the performance characteristics, specifically sensitivity and specificity, deemed acceptable for the device to be marketed.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as target values, but rather implied by the reported performance characteristics that establish substantial equivalence.

Note: The document implies that these performance characteristics were found to be substantially equivalent to a legally marketed predicate device, thus meeting the "acceptance criteria" for regulatory clearance.

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

• Sample Size for Test Set:

  • EBV Performance Summary (Table 3):
    • Negative: 47 (42 negative, 3 current, 2 indeterminate)
    • Current: 40 (33 current, 1 past/recent, 6 indeterminate)
    • Past/Recent: 215 (1 past/recent, 204 past/recent, 8 indeterminate)
    • Total (including Indeterminate): 302 specimens
  • Overall Performance Summary (Table 4):
    • Negative: 49 (42 negative, 5 current, 2 indeterminate)
    • Current: 43 (36 current, 1 past/recent, 6 indeterminate)
    • Past/Recent: 210 (2 past/recent, 199 past/recent, 8 indeterminate)
    • Total (including Indeterminate): 302 specimens
  • Performance Characteristics (Table 5) (Excluding Indeterminates):
    • EBV Infectious Mononucleosis: 241 Current/Past/Recent + 45 Negative = 286 specimens
    • Mononucleosis Syndrome: 239 Current/Past/Recent + 47 Negative = 286 specimens

• Data Provenance: The study was a "prospective study" conducted at "Site A" and "Site B." The country of origin is not explicitly stated, but the sponsor's address is San Diego, CA, USA, implying the study was likely conducted in the USA.

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

The document refers to "Reference Results" for establishing ground truth, but does not specify the number of experts or their qualifications. It only states that these reference results were used to classify samples as Negative, Current, or Past/Recent mononucleosis.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. It mentions "Reference Results" as the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed. This device is an in-vitro diagnostic (ELISA test) that yields an objective result, not an imaging device requiring human reader interpretation in the same way an MRMC study would apply. Therefore, the effect size of human readers improving with AI vs without AI assistance is not applicable and not reported.

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

Yes, a standalone performance study was done. The reported sensitivity and specificity values are for the ImmunoDOT Mono G Test device itself (algorithm only, if one considers the assay as a deterministic algorithm). There is no human-in-the-loop described for the interpretation of the primary quantitative results. The device provides a qualitative output (Negative, Current, Past/Recent, Indeterminate) based on the test's reaction, which is then objectively read.

7. The Type of Ground Truth Used

The ground truth used was based on "Reference Results" which classified samples into "Negative," "Current," and "Past/Recent" categories for mononucleosis. The specific methods or assays used for these reference results are not detailed, but it is implied to be a standard clinical diagnostic method for mononucleosis serodiagnosis. For the CMV and Toxoplasma IM cases, "reference results" were also used to confirm the presumptive diagnoses.

8. The Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. The performance data presented is from a "prospective study" used to assess assay performance, which would typically be analogous to a test or validation set in the context of device approval. For an ELISA assay, the "training" aspect is more related to assay development and optimization rather than a distinct dataset for machine learning.

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

Since a distinct training set for this type of device (ELISA test) is not described, the method for establishing its ground truth is not applicable and not provided.

Ask a specific question about this device

The Mono M Test is a qualitative enzyme immunoassay (EIA) that detects IgM antibodies to Paul-Bunnell heterophil, Epstein-Barr virus capsid antigen (EBV-VCA), and cytomegalovirus (CMV). When used in conjunction with Mono-G Test, it is as an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome.

This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).

The product is an ELISA test method detecting heterophile, viral capsid antigen and cytomegalovirus IgM antibodies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Explicit acceptance criteria are not stated in the provided text. The "Implicit" criteria are inferred from the context of a diagnostic aid device, which typically requires high sensitivity and specificity. The precision results, indicating 100% agreement in most cases, demonstrate excellent qualitative discrimination, which would be an implicit acceptance criterion.

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

• Sample Size:
  • EBV Performance (Combined Data - Table 3):
    • Negative: 42
    • Current: 33
    • Past/Recent: 204
    • Indeterminate: 16 (2+6+8)
    • Total (excluding Indeterminate for calculations in Table 5): 42 + 33 + 204 = 279 samples
  • Overall Performance (Combined Data - Table 4):
    • Negative: 42
    • Current: 36
    • Past/Recent: 199
    • Indeterminate: 16 (2+6+8)
    • Total (excluding Indeterminate for calculations in Table 5): 42 + 36 + 199 = 277 samples
  • Precision Test (Table 6 & 7): Varies by antibody level and analyte, ranging from 36 replicates to 144 replicates for different conditions.
• Data Provenance: Prospective study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the study was conducted to support a U.S. market application. The study involved two sites (Site A and Site B).

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

The document does not provide information on the number of experts or their qualifications used to establish the "Reference Results" for the test set.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set.

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 involving human readers and AI assistance was not mentioned. The device is an ELISA test for laboratory use, not an AI-assisted diagnostic imaging or interpretation system.

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

Yes, a standalone performance study was done. The ImmunoDOT Mono-M Test is an in vitro diagnostic (IVD) device (ELISA test) that generates results directly, which are then interpreted by laboratory personnel. The performance characteristics (sensitivity, specificity, precision) presented are for the device's standalone operation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the performance study is referred to as "Reference Results" (Tables 1, 2, 3, 4). While the exact method for obtaining these reference results is not explicitly detailed, in the context of serodiagnosis for infectious diseases, these typically involve a combination of:

• Confirmatory tests (e.g., Western blot, PCR)
• Clinical diagnosis (symptoms, patient history)
• Expert interpretation of other serological markers or a gold standard method for mononucleosis diagnosis.

Given the nature of the device, it is highly probable that the "Reference Results" represent a well-established serological or clinical gold standard for diagnosing mononucleosis.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of the study. This is typical for traditional in vitro diagnostic devices like ELISA assays, which do not typically involve machine learning or AI models with distinct training and test sets in the same way. The performance studies presented here are primarily for validation.

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

Not applicable, as a distinct training set (in the machine learning sense) and its ground truth establishment are not described for this device type.

Ask a specific question about this device

ImmunoWELL VCA IgM Test is for the qualitative detection of IgM antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

Microtiter ELISA kit detecting VCA IgM antibodies

This document describes the ImmunoWELL VCA IgM Test, a microtiter ELISA kit designed for the qualitative detection of IgM antibodies to Epstein-Barr Virus (EBV) viral capsid antigen (VCA) in human serum. This test is intended to be used as an aid in diagnosing infectious mononucleosis (IM) when used alongside other EBV tests.

The submission claims substantial equivalence to the Epstein-Barr Viral Capsid Antigen IgM ELISA Kit by Gull Laboratories, Inc. Both devices utilize VCA affinity-purified antigen and measure antibodies using ELISA technology in a microtiter assay format.

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

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity or specificity thresholds). Instead, the study's goal was to demonstrate substantial equivalence to the predicate device. The performance is reported in terms of agreement with the predicate device.

Note: The table presented in the input is a 2x2 contingency table comparing the ImmunoWELL VCA IgM Test (labeled "GB") against the Gull EIA.

From this table:

• True Negatives (both negative): 88
• False Negatives (ImmunoWELL negative, Gull positive): 1
• False Positives (ImmunoWELL positive, Gull negative): 0
• True Positives (both positive): 4

This implies:

• Total Gull Negative: 88
• Total Gull Positive: 5 (4+1)
• Total ImmunoWELL Negative: 89 (88+1)
• Total ImmunoWELL Positive: 4

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

• Sample Size for the Test Set: 93 samples (88 negative by predicate + 4 positive by predicate + 1 discrepant). The table shows a total of 93 samples analyzed in the comparison study.
• Data Provenance: The document does not explicitly state the country of origin. It mentions "sera from suspected patients," suggesting these were patient samples collected in a clinical context. The study is retrospective, as it involves testing existing serum samples and comparing the results to a predicate device.

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

The concept of "experts" and their qualifications for establishing ground truth is not applicable in this context. The "ground truth" for the test set is established by the results of the predicate device (Gull Laboratories' Epstein-Barr Viral Capsid Antigen IgM ELISA Kit). The study design compares the new device's results against those of an already legally marketed device, considering the predicate device's results as the reference.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The comparison is a direct concordance analysis between the new device and the predicate device. Discrepancies (one sample was negative by ImmunoWELL but positive by Gull EIA) are noted, but no further adjudication (e.g., by a third expert or a tie-breaker rule) is mentioned.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of a diagnostic kit, not on the interpretation skills of human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

Yes, this is a standalone study of the device (ELISA kit). The performance reported is that of the ImmunoWELL VCA IgM Test kit itself, without human interpretation as a variable. The "human-in-the-loop" concept is more relevant to imaging or AI-assisted diagnostic systems.

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the ImmunoWELL VCA IgM Test was comparison to a legally marketed predicate device (Epstein-Barr Viral Capsid Antigen IgM ELISA Kit, Gull Laboratories, Inc.). The predicate device's results served as the reference standard for assessing the new device's performance.

8. The Sample Size for the Training Set

The document does not provide information on a "training set." This type of diagnostic device (ELISA kit) typically undergoes development and validation using laboratory methods, rather than machine learning training sets. Therefore, there's no mention of a traditional "training set" in the context of an algorithm.

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

As there is no mention of a "training set" in the context of this device's development (which is assumed to be a traditional ELISA kit development rather than an AI algorithm), the establishment of ground truth for a training set is not applicable or described in the provided text.

Ask a specific question about this device

ImmunoWELL EBNA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus nuclear antigen-1 (EBNA-1) in human serum by ELISA. When the EBNA IgG test is used in conjunction with other testing such as the EBV viral capsid IgG or IgM, EBV early antigen IgG tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM) and the stage of EBV infection in adults and children.

Microtiter ELISA kit detecting EBNA antibodies

The provided text describes a 510(k) premarket notification for the "ImmunoWELL EBNA IgG Test" and its substantial equivalence to a predicate device. This document focuses on the performance of an in vitro diagnostic (IVD) device and not an AI/ML powered medical device. Therefore, several requested categories are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, or agreement percentages. Instead, the criterion for acceptance seems to be demonstrating "substantial equivalence" to a legally marketed predicate device. The performance is presented as a comparison table between the new device and the predicate.

Table 1: Gull EIA vs. ImmunoWELL EBNA IgG Test Performance (Clinical Samples)

Interpretation of Table 1:
The table compares the classification of patient samples by the new ImmunoWELL EBNA IgG Test against the predicate Gull EIA. The diagonal elements (65, 7, 8) represent agreement between the two devices. Off-diagonal elements represent disagreement. For example:

• 65 samples were classified as "Past/Recent" by both devices.
• 8 samples were classified as "Past/Recent" by ImmunoWELL but "Current" by Gull EIA.
• 5 samples were classified as "No Past Infection" by ImmunoWELL but "Past/Recent" by Gull EIA.

The summary states the predicate and new device "perform essentially the same when testing sers from suspected patients."

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

• Sample Size for Test Set: The total number of samples used in the comparison study (Table 1) is 70 + 16 + 8 = 94 samples.
• Data Provenance: The document does not explicitly state the country of origin. It describes the samples as "sérums from suspected patients," implying prospective or retrospective clinical samples from a patient population relevant to the intended use. It does not explicitly state whether it’s retrospective or prospective.

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

• Not Applicable. For an IVD device, the "ground truth" is typically established by either a reference method, confirmed clinical diagnosis, or a composite reference standard, rather than expert interpretation of images or other subjective data. In this case, the predicate device (Gull EIA) serves as the comparator for performance, effectively acting as an established "truth" for comparison within the context of substantial equivalence.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used when human interpretation is the primary method of establishing ground truth or performance. For this IVD comparison, the results are quantitative or qualitative classifications from two different assays, making an adjudication method unnecessary.

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

• Not Applicable. This is an IVD device study, not an AI-powered image analysis or diagnostic support system that typically involves multiple human readers evaluating cases with and without AI assistance. Therefore, an MRMC study and effect size in terms context of AI assistance are not relevant here.

6. If a Standalone Performance (Algorithm only without human-in-the-loop performance) was done

• Yes, a standalone performance study was done. The entire study described by Table 1 is a standalone performance comparison. The ImmunoWELL EBNA IgG Test, like the predicate, is an assay that produces an output (qualitative detection of IgG antibody) without immediate human-in-the-loop intervention during the assay execution and primary result generation. The interpretation of the results "in conjunction with other testing" is part of clinical utility, but the device performance itself is standalone.

7. The Type of Ground Truth Used

• The "ground truth" in this context is implicitly the results obtained from the legally marketed predicate device (Gull Laboratories' Epstein-Barr Nuclear Antigen (EBNA) IgG ELISA Kit). The study's goal is to demonstrate that the new device's results are "essentially the same" as those from the predicate.

8. The Sample Size for the Training Set

• Not applicable. The "ImmunoWELL EBNA IgG Test" is an ELISA kit, which is a biochemical assay, not an AI/ML algorithm that requires a training set in the conventional sense. The development of such a kit involves reagent optimization and validation, but not machine learning training.

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

• Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for training in the sense of machine learning.

Ask a specific question about this device

ImmunoWELL. VCA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgG test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgM, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

Microtiter ELISA kit detecting VCA IgG antibodies

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes a comparative study with a predicate device and concludes that the new device performs "essentially the same."

However, we can infer the implicit acceptance criteria based on the study's design: demonstrating substantial equivalence to the predicate device. The performance data presented is a cross-tabulation comparing the new device (ImmunoWELL) with an "Alternate EIA" (which, based on the context of the predicate device, likely refers to the Gull EIA, or a similar method used for comparison).

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

• Test Set Sample Size: The sum of all cases in the provided table is 65 + 8 + 0 + 0 + 7 + 0 + 5 + 1 + 8 = 94 samples.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin or whether the data was retrospective or prospective. It only refers to "sera from suspected patients."

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

This information is not provided in the text. The study relies on a comparison against an "Alternate EIA" (likely the predicate device or a similar established method) rather than a defined ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided in the text. Given that the comparison is between two EIA tests, there's no indication of an adjudication process in the traditional sense involving human review of discrepancies beyond the test results themselves.

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

• No, an MRMC comparative effectiveness study was not conducted. This study describes the performance of an in vitro diagnostic (IVD) device, which is an automated test, not a system designed to assist human readers in image interpretation or similar tasks where MRMC studies are typically performed.

6. Standalone (Algorithm Only) Performance

• Yes, the study describes the standalone performance of the ImmunoWELL VCA IgG Test. Since it is an ELISA kit, its performance is inherently "algorithm only" in the context of an IVD, meaning it operates independently to produce a result. The study compares this standalone performance to another standalone IVD (the predicate device).

7. Type of Ground Truth Used

• The study uses the results of an "Alternate EIA" (likely the predicate device or a highly similar established method) as the reference for comparison. While not explicitly termed "ground truth," this serves as the benchmark against which the new device's performance is measured to establish substantial equivalence. It's a comparative agreement study rather than a direct validation against a clinical "ground truth" like pathology or long-term outcomes. The text mentions the results "can serve as an aid in the diagnosis of infectious mononucleosis (IM)" when used with other tests, indicating that a definitive diagnosis relies on a panel of results, not just this one.

8. Sample Size for the Training Set

• This information is not provided in the text. For IVD devices like this ELISA kit, there isn't typically a "training set" in the machine learning sense. The device's parameters and performance characteristics are established through analytical and clinical validation studies, rather than by training a learnable algorithm.

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

• As there is no "training set" in the context of an ELISA kit, this question is not applicable. The development of such a kit involves biochemical and immunological design, optimization, and characterization rather than a data-driven training process for an algorithm.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device