Search Results

The ARCHITECT HSV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of specific IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum (collected in serum and serum separator tubes) and plasma (collected in dipotassium EDTA, lithium heparin plasma separator tubes) on the ARCHITECT i System.

The ARCHITECT HSV-2 IgG assay is to be used for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lessociated disease manifestations, particularly for primary infection. The predictive value of a reactive or nonreactive result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

NOTE: The performance of the ARCHITECT HSV-2 IgG assay has not been established for use in the pediatric population, for neonatal screening, or for testing immunosompromised or immunosuppressed patients. The assay has not been FDA cleared or approved for screening blood or plasma donors.

The ARCHITECT HSV-2 IgG assay is an automated, two-step immunoassay for the qualitative detection of IgG antibodies to HSV-2 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.

The kit contains different components: Reagent (microparticles, conjugate and assay diluent), Calibrator, and external Controls (reactive and nonreactive).

The document describes the ARCHITECT HSV-2 IgG assay, a diagnostic device for detecting specific IgG antibodies to herpes simplex virus type 2 (HSV-2). The study aims to demonstrate that this new device is substantially equivalent to legally marketed predicate devices.

While the document does not explicitly state "acceptance criteria" in the format of a separate table setting thresholds beforehand, the performance summary sections detail the studies and the observed performance. The key performance metrics demonstrated are:

• Clinical Performance (Positive Percent Agreement - PPA and Negative Percent Agreement - NPA): This is the primary measure of the device's accuracy in correctly identifying positive and negative samples for HSV-2 IgG antibodies.
• Precision (Within-Laboratory and Reproducibility): These studies evaluate the consistency and reliability of the assay results across different runs, days, and sites.
• Analytical Specificity (Interference and Cross-reactivity): These studies assess the device's ability to accurately measure HSV-2 IgG without being affected by other substances or related conditions.
• Specimen Collection Types: This confirms the assay's performance across various accepted sample types.
• Carry-Over: Verifies that prior samples do not affect subsequent sample results.

Here's an interpretation of the implied acceptance criteria and reported performance based on the provided document:

Acceptance Criteria and Reported Device Performance

• PPA: 96.54% (223/231) with 95% CI: 93.32% to 98.24%
• NPA: 96.90% (375/387) with 95% CI: 94.66% to 98.22%

Pregnant Population:

• PPA: 95.12% (78/82) with 95% CI: 88.12% to 98.09%
• NPA: 98.60% (212/215) with 95% CI: 95.98% to 99.52%

CDC Panel Agreement:

• PPA (Reactive samples): 100% (30/30)
• NPA (Nonreactive samples): 97.14% (68/70) |
  | Precision (Within-Laboratory) | Low %CV for different panels and controls, demonstrating consistent results within the laboratory. | 20-Day Within-Laboratory Precision:
• Positive Control: Mean S/CO 3.01, Within-Laboratory %CV 3.9
• Serum Panel 2: Mean S/CO 1.60, Within-Laboratory %CV 6.8
• Serum Panel 3: Mean S/CO 2.47, Within-Laboratory %CV 11.6
• Plasma Panels: %CVs ranging from 3.3 to 5.7

12-Day Within-Laboratory Precision (Higher Analyte Levels):

• Serum Panel 4: Mean S/CO 7.14, Within-Laboratory %CV 5.2
• Serum Panel 5: Mean S/CO 14.73, Within-Laboratory %CV 4.6
• Plasma Panel 4: Mean S/CO 7.85, Within-Laboratory %CV 4.5
• Plasma Panel 5: Mean S/CO 14.90, Within-Laboratory %CV 5.0 |
  | Precision (Reproducibility) | Low %CV across multiple sites/instruments, demonstrating consistent results regardless of testing location. | Reproducibility (3 testing sites):
• Positive Control: Mean S/CO 2.98, Reproducibility %CV 5.2
• Serum Panel 2: Mean S/CO 1.56, Reproducibility %CV 4.0
• Serum Panel 3: Mean S/CO 2.52, Reproducibility %CV 4.3
• Plasma Panels: %CVs ranging from 5.2 to 5.4 |
  | Analytical Specificity (Interference) | Minimal impact (

Ask a specific question about this device

lmmunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

This test is not FDA-cleared for screening blood or plasma donors.

The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients or for use at point-of-care facilities.

The Elecsys HSV-2 IgG immunoassay makes use of a sandwich test principle using biotinylated recombinant HSV-2-specific antigens and HSV-2-specific recombinant antigens labeled with a ruthenium complex. The Elecsys HSV-2 IgG immunoassay is intended for the qualitative determination of lgG class antibodies to HSV-2 in human serum and in the presumptive diagnosis of HSV-2 infection. It is intended for use on the cobas e immunoassay analyzers. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration.

The Elecsys HSV-2 IgG (08948887160) device is an immunoassay for the qualitative determination of IgG class antibodies to HSV-2. The study involved a comparison against a predicate device (K121895).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity thresholds) that were required for clearance or the corresponding reported device performance values in a quantitative manner. Instead, it focuses on demonstrating substantial equivalence to a predicate device and improved technical characteristics.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)" section is where such data would typically be found, but it is not expanded upon in the provided text. The submission describes technological improvements to biotin tolerance and streptavidin interference, which are performance characteristics.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed within the non-clinical and/or clinical test summary.

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

The provided text does not specify the number of experts used to establish the ground truth for the test set or their qualifications. For an immunoassay, the ground truth would typically be established by a reference method or a panel of samples with confirmed HSV-2 status, rather than expert interpretation of images or clinical cases.

4. Adjudication Method

The provided text does not specify any adjudication method. For an immunoassay, adjudication might not be relevant in the same way as for subjective diagnostic tasks like image interpretation, as the result is typically a quantitative measurement converted to a qualitative outcome.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, as this device is an immunoassay and does not involve human readers interpreting cases in the same way an imaging diagnostic device would. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone Performance

The device itself is a standalone immunoassay. Its performance is measured directly through its ability to detect HSV-2 IgG antibodies. While the document mentions "cobas e immunoassay analyzers" for its use, the performance described would implicitly be the standalone performance of the assay on these automated platforms. The provided text does not provide quantitative standalone performance metrics such as sensitivity and specificity.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated in the provided text. However, for an immunoassay for antibodies, the ground truth for test samples would typically be established by:

• Reference methods: Such as Western blot, more sensitive PCR, or another highly validated immunoassay.
• Clinical diagnosis and follow-up: Including a history of recurrent genital lesions confirmed by viral culture or PCR.
• Well-characterized seroconversion panels: For sensitivity studies.

Given that this is an immunoassay for IgG antibodies to HSV-2, the ground truth would likely involve confirmed HSV-2 infection status based on established laboratory methods and/or clinical presentation.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set. Immunoassays are typically "trained" during their development and optimization phases using numerous characterized samples to establish appropriate cut-offs and ensure performance.

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

The provided text does not specify how the ground truth for the training set was established. Similar to the test set, it would have involved established laboratory reference methods and/or clinical confirmation of HSV-2 status. For an immunoassay, training involves optimizing reagent concentrations, reaction conditions, and setting cut-off values using panels of known positive and negative samples.

Ask a specific question about this device

The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA), which is performed in microwells, at room temperature, and in three thirty-minute incubations. The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.

This document describes the performance of the SeraQuest® HSV Type 2 Specific IgG assay when performed on the ChemWell® Automated Analyzer, comparing it to the previously cleared manual method.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated section. However, the "Method Comparison Study" presents the core performance metrics (Positive Percent Agreement and Negative Percent Agreement) against the predicate device. For the purpose of this response, we infer that high agreement with the predicate device is the acceptance criterion.

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

• Sample Size for Test Set: 226 samples.
• Data Provenance: Samples were developed from "remnants of patient samples and samples from vendors." Additional samples were prepared by spiking negative samples with positive samples or dilution with diluent reagent to span the range of the assay's measuring interval. The country of origin is not specified, but it can be inferred as being related to the applicant's location (Palm City, Florida, USA). The study appears to be a retrospective evaluation using existing or manufactured samples.

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

The ground truth for the test set was established by comparison against a predicate device (manual method), not by independent expert interpretation. Therefore, experts were not explicitly used to establish the ground truth for this device in the context of this study. The "ground truth" here is the result obtained from the established manual method.

4. Adjudication Method for the Test Set

No adjudication method using multiple readers or experts is described, as the comparison is between two automated/semi-automated assay methods (the new device vs. the predicate). The "truth" for the comparison was the result generated by the manual method.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This study focuses on the equivalence of an automated assay to a manual assay, not on human reader performance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone comparison was done. The study directly compares the performance of the "SeraQuest® HSV Type 2 Specific IgG assay performed by ChemWell® Automated Analyzer" (the new device) against the "SeraQuest® HSV Type 2 Specific IgG assay performed by Manual Method" (the predicate device). This evaluates the algorithm/device performance independently of human interpretation, focusing on concordance between the two methods.

7. Type of Ground Truth Used

The type of ground truth used was comparison to a predicate device (manual assay results). This means the "truth" for evaluating the automated analyzer was the result provided by the already cleared manual method.

8. Sample Size for the Training Set

The document does not explicitly mention a separate training set or its sample size. The study focuses on verifying the performance of the automated analyzer against the predicate manual method using the 226 samples for method comparison and additional samples for precision studies.

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

Since a separate training set is not explicitly described, the method for establishing its ground truth is also not detailed. The validation approach is based on demonstrating equivalence to an existing, cleared method.

Ask a specific question about this device

The ADVIA Centaur® Herpes-2 IgG (HSV2) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum and plasma (EDTA and lithium heparin).

The ADVIA Centaur Herpes-2 IgG (HSV2) assay is a fully automated two-step sandwich immunoassay using indirect chemiluminometric technology. The specimen is incubated with the Solid Phase, which contains HSV-2-specific recombinant-gG2 antigen. Antigen-antibody complexes will form if anti-HSV-2 antibody is present in the specimen. The Lite Reagent contains monoclonal anti-human IgG labeled with acridinium ester, and is used to detect HSV-2 IgG in the specimen.

The provided document describes the performance of the ADVIA Centaur Herpes-2 IgG (HSV2) assay, which is an in vitro diagnostic device. The study aims to demonstrate that the device meets acceptance criteria for substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance characteristics and compares them against design requirements or expected outcomes.

2. Sample Size and Data Provenance

• Precision Study: 6 samples and Negative/Positive Controls. Each material tested in duplicate, twice a day for 20 days.
  • N = 80 replicates per level for within-lab precision.
• Sample Matrix Study: 68 sets of matched samples (serum, serum separator tube, EDTA plasma, lithium heparin plasma).
• Panel Testing:
  • ToRCH-mixed Zeptometrix panel: 24 characterized HSV samples.
  • CDC panel: 100 blind characterized HSV samples.
• Cross-Reactivity Study: 522 specimens across various clinical categories.
• Multi-site Reproducibility: 6 samples and Negative/Positive Controls.
  • N = 90 replicates per level (from 3 external sites, 5 days, 2 runs/day, 3 replicates/run).
• Clinical Study:
  • Total: 864 specimens (≥ 18 years of age), including 274 pregnant women.
  • Data Provenance: Specimens collected within the United States. The study was conducted at 3 independent external laboratories. The nature of the specimen collection implies it was prospective for the purpose of this study, although the individual samples may have been sourced retrospectively from biobanks or collected prospectively for the study itself. The document does not explicitly state "retrospective" or "prospective" for the clinical sample collection, but "collected within the United States" and tested at external labs suggests purpose-collected samples for the study.

3. Number of Experts and Qualifications for Ground Truth

• The document implies the use of "reference assay 1" for the ToRCH-mixed Zeptometrix panel and "results provided by the CDC" for the CDC panel, as well as a "Comparative Assay" and "validated Western Blot reference confirmatory test (University of Washington, Seattle)" for the clinical study and cross-reactivity assessment.
• Number of Experts: Not explicitly stated how many individual experts established the ground truth for these reference methods. The description refers to "characterized HSV samples" for panels and "validated Western Blot" from a university, which implies expert consensus or highly standardized laboratory procedures.
• Qualifications of Experts: Not explicitly stated (e.g., "radiologist with 10 years of experience" is not applicable here as it's an in vitro diagnostic test for antibodies). However, the use of "validated Western Blot" from a reputable institution (University of Washington, Seattle) and "CDC" as sources for ground truth implies the highest level of expertise and validated methodologies in serological testing.

4. Adjudication Method for the Test Set

• For the clinical study: Of the 864 specimens, 22 were equivocal with the Comparative Assay. These 22 samples were resolved by Western Blot testing. 20 were resolved to be negative, and 2 remained equivocal. This describes a form of adjudication where an equivocal result from one reference method is adjudicated by a more definitive reference method (Western Blot).
• No multi-reader consensus (e.g., 2+1, 3+1) is mentioned, as this is an in vitro diagnostic assay, not an image-reading task.

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

• No MRMC comparative effectiveness study was done. This type of study is typically performed for AI/CAD systems that assist human readers in interpreting medical images, not for in vitro diagnostic assays like this one which provides a quantitative or qualitative result directly.

6. Standalone (Algorithm Only) Performance

• This device is an automated immunoassay (ADVIA Centaur HSV2 assay). Its performance is inherently "standalone" in the sense that it directly measures antibodies without human interpretation in the loop to generate the initial result. The reported sensitivity and specificity values are for the device (algorithm) itself against the established ground truth.

7. Type of Ground Truth Used

• Expert Consensus / Highly-validated Reference Methods:
  • For panels: "characterized HSV samples," "reference assay 1," and "results provided by the CDC."
  • For clinical and cross-reactivity studies: A Comparative Assay (likely another FDA-cleared or well-established commercial immunoassay) and a validated Western Blot reference confirmatory test (University of Washington, Seattle). Western Blot is generally considered a highly specific and confirmatory test for antibody presence in serology. The use of a confirmatory test like Western Blot for equivocal results strengthens the ground truth.

8. Sample Size for the Training Set

• The document describes a 510(k) submission for an in vitro diagnostic device (immunoassay). Immunoassays are based on biochemical reactions and established calibration curves, not typically on machine learning models requiring large "training sets" in the same sense as AI/ML software. Therefore, a "training set" for an algorithm, as understood in AI/ML, isn't applicable or mentioned for this device. The development process would involve characterization, optimization, and validation using various samples, but not "training data" for a learnable algorithm.

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

• As explained in point 8, the concept of a "training set" with ground truth establishment in the AI/ML sense does not apply to this immunoassay. The device's performance is driven by its reagent chemistry and instrumentation, not by a trained algorithm.

Ask a specific question about this device

Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA) , which is performed in microwells, at room temperature, and in three thirty minute incubations The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has 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 HSV Type 2 Specific IgG device, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Precision Testing: 6 serum specimens (2 negative, 4 positive) and the SeraQuest Positive and Negative Controls. Each sample/control was assayed in triplicate, on three separate occasions, at three different laboratories (Quest International and two external independent laboratories). This results in a total of 27 data points per sample/control (3 triplicates * 3 occasions * 3 labs).
   • Specificity Testing:
     • HSV 1 IgG: 9 samples
     • CMV IgG: 11 samples
     • VZV EBNA IgG: 14 samples
     • VZV VCA IgG: 17 samples
     • VZV IgG: 21 samples
     • Measles IgG: 19 samples
     • Rubella IgG: 18 samples
     • Toxoplasma IgG: 6 samples
     • Syphilis IgG: 4 samples
     • Human Papilloma Virus: 7 samples
     • Chlamydia trachomitis: 8 samples
     • Neisseria gonorrhea: 7 samples
     • Provenance: Samples positive for various related pathogens/antibodies but negative for Type 2 HSV by another legally marketed device. Human Papilloma Virus, Chlamydia trachomitis, and Neisseria gonorrhea samples were from individual patients with confirmed sexually transmitted infections.
   • Interference Testing: Samples that were negative, weakly positive, and moderately positive for antibodies to Type 2 HSV were tested with and without the addition of elevated levels of specific interfering substances. (No specific number of samples provided for this test).
   • Comparison with Predicate Device:
     • Sexually Active Adults: 164 serum samples. Provenance: Prospectively collected, masked, archived, and tested at Quest International, Inc. from a clinical laboratory in the Southeastern United States.
     • Expectant Mothers: 242 serum samples. Provenance: Prospectively collected, masked, archived, and tested at Quest International, Inc. from clinical laboratories in the Northeastern and Southeastern United States. 82% from first trimester, 8% second, 10% third.
   • CDC Panel: 100 sera (30 HSV-2 IgG positive and 70 HSV-2 IgG negative samples). Provenance: Centers for Disease Control and Prevention (CDC) serum panel.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated for most studies.

   • For the cross-reactivity study, the samples were determined positive for various related pathogens "by other legally marketed devices" and confirmed negative for Type 2 HSV by a legally marketed device. This implies a standard diagnostic process, but no specific human experts or qualifications are mentioned for this initial determination.
   • For the comparative studies with the predicate device (Immunoblot), the ground truth was established by the predicate device itself. While the predicate device is a "legally marketed" test, it doesn't specify human expert interpretation or qualifications.
   • For the CDC Panel, the ground truth is "CDC consensus results" and the panel samples are described as "well characterized," implying established expert consensus or reference methods. No specific number of experts or their qualifications are detailed.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated. The ground truth seems to be established by reference methods or legally marketed devices rather than direct human adjudication of results in most cases. For the CDC panel, it's "CDC consensus results," which implies an agreed-upon truth, but the adjudication method isn't described.

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:

   • No MRMC comparative effectiveness study involving human readers or AI assistance was conducted or reported for this device. This is an IVD (In Vitro Diagnostic) assay, not an imaging AI device.

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

   • Yes, the performance characteristics (sensitivity, specificity, precision, etc.) of the SeraQuest HSV Type 2 Specific IgG assay were evaluated as a standalone device. Its results are compared to a predicate device (Immunoblot) or a "well characterized serum panel" (CDC panel). There is no "human-in-the-loop" component described for this specific device in the context of its performance evaluation.

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

   • Precision: Internal controls and reference samples.
   • Specificity: Samples characterized by other legally marketed devices (positive for related pathogens, negative for HSV-2) and confirmed sexually transmitted infections.
   • Interference: Artificially spiked samples.
   • Comparison Studies: A "commercial HSV 2 Immunoblot test" (predicate device) was used as the reference standard for both sexually active adults and expectant mothers. This is a type of reference test ground truth.
   • CDC Panel: "CDC consensus results" from a "well characterized serum panel." This implies expert consensus or a gold standard determination for each sample in the panel.

7. The sample size for the training set: Not applicable and not mentioned. This document describes the performance evaluation of a medical device (an ELISA assay), not a machine learning or AI model that requires a "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection.

The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing.

The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.

Not Found

This document describes the FDA's decision to clear the Zeus ELISA HSV gG-2 IgG Test System, not a study report detailing its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided text.

However, I can extract what is implied about the regulatory context and intended use, which informs the type of studies typically required for such devices.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided as the document is an FDA clearance letter, not a study report. It does not contain specific acceptance criteria values (e.g., sensitivity, specificity thresholds) or the reported performance data from a clinical study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not describe the test set size, its provenance, or whether the study was retrospective or prospective.

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)

• Cannot be provided. The document does not describe how ground truth was established, nor the number or qualifications of experts. Given that this is an in-vitro diagnostic device for serological testing, the "ground truth" would likely be established through a combination of other established testing methods rather than expert consensus on images.

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

• Cannot be provided. The document does not discuss adjudication methods.

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 and cannot be provided. This is an in-vitro diagnostic device (ELISA test) for detecting antibodies, not an imaging device intended for interpretation by human readers, nor does it involve AI assistance for human interpretation.

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

• Implied as 'yes' for the device itself. The device, an ELISA test system, operates as a standalone diagnostic tool to detect antibodies. It's a laboratory test, not an AI algorithm. Its performance is measured directly, not in conjunction with human interpretation for improvement.

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

• Cannot be provided explicitly, but typically for serological tests: Ground truth for serological assays like this often involves a composite reference standard, which can include multiple established laboratory tests (e.g., Western Blot, viral culture, PCR, or other highly sensitive and specific serological assays).

8. The sample size for the training set

• Cannot be provided. The document does not mention a training set, as it's an ELISA assay, not a machine learning algorithm that requires supervised training data.

9. How the ground truth for the training set was established

• Cannot be provided. Not applicable as explained above.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter for the Zeus ELISA HSV gG-2 IgG Test System. It indicates that the device has been found "substantially equivalent" to legally marketed predicate devices, allowing its commercialization. The letter itself does not contain the detailed clinical study data, including acceptance criteria or performance metrics, that would have been submitted by the manufacturer to the FDA for review.

The primary information available is:

• Device Name: Zeus ELISA HSV gG-2 IgG Test System
• Indications for Use: Qualitative detection of type-specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum for aiding in the presumptive diagnosis of HSV-2 infection in sexually active individuals or pregnant women.
• Limitations: Not intended for donor screening or self-testing. Performance not established for pediatric population, neonates, or immunocompromised patients.
• Regulatory Class: Class II
• Product Code: MYF
• Regulatory Pathway: 510(k) (substantial equivalence)

To obtain the specific acceptance criteria and detailed study data, one would typically need to consult the 510(k) summary submitted by Zeus Scientific, Inc. to the FDA, which is usually publicly available on the FDA's website after clearance, or the device's Instructions For Use (IFU)/package insert. These documents would detail the specific studies performed (e.g., sensitivity, specificity, reproducibility, interference studies) and the results that demonstrated substantial equivalence.

Ask a specific question about this device

The LIAISON® HSV-2 Type Specific IgG assay is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the qualitative determination of type specific IgG antibodies to Herpes simplex virus Type 2 (HSV-2) in human serum. The assay is indicated for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection.

The LIAISON® HSV-2 Type Specific IgG assay has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. The assay is neither FDA cleared nor approved for testing blood or plasma donors.

The LIAISON® Control HSV-2 (negative and positive) are intended for use as assayed quality control samples to monitor the performance of the LIAISON® HSV-2 Type Specific IgG assay.

The method for qualitative determination of specific IgG to HSV-2 is an indirect chemiluminescence immunoassay (CLIA). HSV-2 gG2 recombinant antigen is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody is linked to an isoluminol derivative (isoluminolantibody conjugate), During the first incubation, HSV-2 antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with HSV-2 IgG already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of HSV-2 IgG concentration present in calibrators, samples or controls.

The information provided details the performance study for the LIAISON® HSV-2 Type Specific IgG assay, but it does not explicitly state pre-defined acceptance criteria for sensitivity and specificity that the device must meet. Instead, it presents the performance data and then concludes that the device performed equivalently to an FDA-cleared comparison method.

However, based on the provided data, we can infer the reported performance metrics.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

As mentioned, no explicit "acceptance criteria" are given in terms of numerical thresholds for sensitivity and specificity. The study aims to demonstrate "equivalent performance" to the predicate device. Therefore, the table below will list the reported performance values.

2. Sample size used for the test set and the data provenance:

• Total Test Set Sample Size: 951 samples for comparison against the FDA-cleared Immunoblot.
  • 401 samples from Sexually Active Adults
  • 430 samples from Expectant Mothers
  • 120 samples from a "Low Prevalence" population
  • Additionally, a 100-sample CDC panel (52% positive, 48% negative) was used for further performance assessment.
• Data Provenance:
  • Country of Origin: Northeastern United States for the 951 samples. The CDC panel provenance is not specified beyond being from the Centers for Disease Control and Prevention.
  • Retrospective or Prospective: Not explicitly stated, but the description "samples collected" and "samples obtained" suggests a retrospective collection of existing samples, rather than prospective enrollment for the purpose of this study.

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

The ground truth was primarily established using an FDA-cleared Immunoblot (Predicate Device: Focus Diagnostics HerpeSelect® 1 and 2 Immunoblot IgG, K000238). For equivocal samples on the predicate device, Western Blot testing was performed by a Reference Laboratory in the Pacific Northwest.

• Number of Experts: Not applicable in the context of human expert review for independent ground truth. The initial ground truth was established by another diagnostic device (the predicate Immunoblot).
• Qualifications of Experts: Not applicable, as the primary ground truth was instrument-based. The "Reference Laboratory" for Western Blotting implies trained laboratory personnel, but specific qualifications are not mentioned.

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

• Adjudication Method: Not applicable in the traditional sense of multiple human readers adjudicating results. The ground truth was established by a predicate device, and for equivocal results from the predicate, a Western Blot was used for resolution. This acts as a form of reference method adjudication for indeterminate cases from the predicate.

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:

• MRMC Study: No, this was not a multi-reader multi-case comparative effectiveness study. This study compares the performance of a new in vitro diagnostic device (LIAISON® HSV-2 Type Specific IgG assay) against a legally marketed predicate device (FDA cleared Immunoblot). It does not involve human readers' interpretation of results that are enhanced or assisted by AI.

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

• Standalone Performance: Yes, the study evaluated the LIAISON® HSV-2 Type Specific IgG assay as a standalone diagnostic device. It is an automated chemiluminescent immunoassay (CLIA) and its performance is measured independently against the predicate device and Western Blot as reference methods. It does not involve a human in the loop for interpreting the assay's primary output.

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

• Ground Truth Type: A combination of a legally marketed predicate device (FDA-cleared Immunoblot) and a reference laboratory method (Western Blot) for resolving equivocal results from the predicate device. This is a common approach for establishing ground truth in diagnostic device comparisons. The CDC panel serves as an external, well-characterized control for further validation.

8. The sample size for the training set:

• Training Set Sample Size: Not explicitly stated or provided in the document. The document describes a "comparative clinical trial" and "reproducibility study" for performance validation, not the development or training of the assay itself. The LIAISON® HSV-2 Type Specific IgG assay is an immunoassay, the "training" aspect is related to the assay's development and optimization, for which specific sample sizes are not typically released in 510(k) summaries for such devices.

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

• Ground Truth for Training Set: Not specified. As an immunoassay, its "training" involves optimizing reagents, concentrations, and reaction conditions during its development phase. The ground truth for this optimization would typically involve well-characterized positive and negative serum samples, likely confirmed by established reference methods (e.g., Western Blot, clinical diagnosis, culture), but these details are not part of the provided 510(k) summary focused on validation.

Ask a specific question about this device

The EUROIMMUN Anti-HSV-1 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against Herpes simplex virus type 1 (HSV-1) specific glycoprotein C1 in human serum. It is intended for the presumptive diagnosis of type specific HSV-1 infection with EUROIMMUN Anti-HSV-2 EUSA (IgG) in persons suspected of herpes viral infection.

The EUROIMMUN Anti-HSV-2 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against herpes simplex virus type 2 (HSV-2) specific glycoprotein G2 in human serum. It is intended for the presumptive diagnosis of type specific HSV-2 infection with EUROIMMUN Anti-HSV-1 EUSA (lgG) in persons suspected of herpes viral infection.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the EUROIMMUN Anti-HSV-1 ELISA (IgG) Kit and EUROIMMUN Anti-HSV-2 ELISA (IgG) Kit. It primarily focuses on the FDA's determination of substantial equivalence to previously marketed devices. While it states the intended use of the devices, it does not contain detailed information about the acceptance criteria and study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval letter, not a study report.

Ask a specific question about this device

The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 2 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human serum. In conjunction with the Trinity Biotech Captia™ Herpes Simplex Virus (HSV) I Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western blot. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment. The user is responsible for establishing assay performance in these populations and with automated equipment.

The CaptiaTM HSV 2 IgG Type Specific kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to Herpes simplex Type 2 antigen. The Captia™ HSV 2 IgG Type Specific assay may be used as an aid in the diagnoses of Herpes infection. Purified recombinant HSV gG2 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.

The provided document details the performance characteristics of the Captia™ HSV 2 IgG Type Specific ELISA Test Kit. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve X% sensitivity and Y% specificity"). Instead, it presents the performance of the device against a predicate device (Western Blot) and an alternate ELISA. The reported performance is summarized below from different study populations. The predicate device used for comparison is the Western Blot (WB) from a Pacific Northwest university.

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

The document describes several distinct test sets:

• Expectant Mothers:
  • Sample Size: n = 210
  • Data Provenance: Consented, coded, unselected, banked, and masked sera. The reference method (Western Blot) was from a Pacific Northwest university. This suggests retrospective data.
• Sexually Active Adults:
  • Sample Size: n = 198
  • Data Provenance: Consented, unselected, and masked sera. The reference method (Western Blot) was from a Pacific Northwest university. This suggests retrospective data.
• Low Prevalence Population:
  • Sample Size: n = 184
  • Data Provenance: Unselected, banked, and masked sera. The reference method (Western Blot) was from a Pacific Northwest university. This suggests retrospective data.
• Culture Positives:
  • Sample Size: n = 56
  • Data Provenance: Unselected, retrospective, and masked sera from patients at least six weeks but not more than one year post clinical presentation and culture HSV 2 positive. Reference methods (culture and Western Blot) were from a Pacific Northwest university.
• Prospectively Collected, Sequential Sera (vs. Alternate ELISA):
  • Sample Size: n = 200
  • Data Provenance: Prospective, unselected, sequentially submitted specimens. Collected by an outside investigator at a Pacific Northwest University.
• Type Specificity with HSV 1 Western Blot Positives:
  • Sample Size: n = 292
  • Data Provenance: HSV 1 Western Blot positive and HSV 2 Western Blot negative sera from the above described populations (expectant mothers, sexually active adults, low prevalence persons, and HSV 1 culture positives). Collected by an outside investigator at a Pacific Northwest University. This is a retrospective analysis of previously collected samples.

In general, the data seems to be from the United States (Pacific Northwest university) and is predominantly retrospective (banked, unselected, masked, retrospective sera), with one prospective study for comparison against an alternate ELISA.

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

The document does not explicitly mention "experts" in the context of establishing ground truth. The ground truth for comparative studies is established by reference methods, primarily:

• Western Blot (WB): From a "Pacific Northwest university." No specific detail on the qualifications of the individuals performing or interpreting the Western Blot.
• Culture (for Culture Positives set): Implies standard laboratory procedure for viral culture, not explicitly associated with "experts" in this context.

Therefore, the specific number and qualifications of experts beyond the unspecified standard practices of a university lab for performing Western Blots and cultures are not detailed in the provided information.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1). The comparisons are directly between the Captia™ ELISA and the reference method results. There's no mention of a process where multiple readers or experts review discordant results to reach a consensus.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (ELISA test kit) and does not involve human readers interpreting images or results, nor does it incorporate AI. Its performance is measured directly against laboratory reference standards.

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

Yes, the studies presented describe the standalone performance of the Captia™ HSV 2 IgG Type Specific ELISA Test Kit. This is an enzymatic immunoassay (ELISA) performed in a laboratory setting, and its efficacy is measured by comparing its outputs directly against established reference methods (Western Blot, culture, or another ELISA). There is no "human-in-the-loop" component in the performance evaluation described, beyond the technical execution of the tests themselves.

7. The type of ground truth used

The primary type of ground truth used across the various studies is:

• Reference Standard (Western Blot): The Western Blot (WB) method from a Pacific Northwest university served as the gold standard for serological detection of HSV 2 IgG antibodies in most studies.
• Culture: For the "Culture Positives" group, the ground truth for actual infection was established by HSV 2 culture positivity.
• Alternate ELISA: In one study, another commercially available HSV 2 type-specific IgG ELISA was used as a comparative reference.

8. The sample size for the training set

The document provides performance data based on comparative studies with clinical samples. It does not mention a "training set" in the context of machine learning or algorithm development. This is a traditional IVD device, not an AI-driven algorithm. The performance evaluation focuses on the device's accuracy against established reference methods using specific test populations.

9. How the ground truth for the training set was established

As there is no explicit "training set" described for the development of a machine learning algorithm, this question is not applicable. The device's underlying mechanism is a biochemical ELISA, not an algorithm that learns from data. Its "ground truth" for development would relate to the antigen/antibody interactions it's designed to detect.

Ask a specific question about this device

MRL Diagnostics' HSV-2 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human sera. In conjunction with the MRL HSV-1 ELISA IgG, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-2 infection. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment.

In the MRL Diagnostics HSV-2 ELISA IgG assay, the polystyrene microwells are coated with recombinant gG-2 antigen. Diluted serum samples and controls are incubated in the wells to allow specific antibody present in the samples to react with the antigen. Nonspecific reactants are removed by washing, and peroxidase-conjugated anti-human IgG is added and reacts with specific IgG. Excess conjugate is removed by washing. Enzyme substrate and chromogen are added, and the color is allowed to develop. After adding the Stop Reagent, the resultant color change is quantified by a spectrophotometric reading of optical density (OD). Sample optical density readings are compared with reference cut-off OD readings to determine results.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text for the MRL Diagnostics HSV-2 ELISA IgG device (K993724):

The provided text describes a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit "acceptance criteria" for performance in the same way a clinical trial might. However, we can infer performance targets based on the data presented and comparisons to the reference methods.

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Ask a specific question about this device