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The INCSTAR Toxoplasma IgM Capture ELISA kit contains instructions and materials for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active Toxoplasma gondii infection. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.

The INCSTAR Toxoplasma IgM Capture ELISA Kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with monoclonal mouse antibody against human IgM (u chain specific) bound to the solid surface of the microtiter well. : Patient IgM is "captured" by the surface bound antibody. The presence of patient anti-Toxoplasma IgM antibodies are then "detected" and bound by Toxoplasma antigen which is linked to an anti-Toxoplasma antibody conjugated to horseradish peroxidase. Bound horseradish peroxidase is reacted with chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm / 630 nm, is directly proportional to the concentration of IgM to Toxoplasma antigen present in the reaction solution.

{
  "1": {
    "table_of_acceptance_criteria_and_reported_device_performance": {
      "Acceptance Criteria": [
        "Relative sensitivity: 91% to 99% (95% confidence intervals)",
        "Relative specificity: 99% to 100% (95% confidence intervals)",
        "Overall agreement: 97% to 100% (95% confidence intervals)"
      ],
      "Reported Device Performance": [
        "Relative sensitivity: 91% to 99%",
        "Relative specificity: 99% to 100%",
        "Overall agreement: 97% to 100%"
      ]
    },
    "sample_size_test_set_data_provenance": "406 serum samples from 375 individuals. The data provenance is not explicitly stated as retrospective or prospective, nor the country of origin, but it represents a \"mixed population of healthy donors, transplant patients, immunocompromised hosts, pregnant women, Toxoplasma proven individuals, and patients having various other illnesses.\"",
    "number_of_experts_ground_truth_test_set_qualifications": "Not applicable. The ground truth for the test set was established by comparison to a cleared predicate device (BioWhittaker TOXOCAP-M ELISA kit), not by expert consensus.",
    "adjudication_method_test_set": "Not applicable. The ground truth for the test set was established by comparison to a cleared predicate device, not through expert adjudication.",
    "multi_reader_multi_case_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a diagnostic kit, not an AI-assisted interpretation system for human readers.",
    "standalone_algorithm_only_performance": "Yes, a standalone performance study was done. The study compares the performance of the INCSTAR Toxoplasma IgM Capture ELISA Kit to a predicate device, which inherently evaluates the algorithm (kit) on its own.",
    "type_of_ground_truth_used": "Comparative ground truth based on a predicate device (BioWhittaker TOXOCAP-M ELISA kit).",
    "sample_size_training_set": "Not applicable. The document describes a diagnostic kit, and the performance study is a validation study comparing it to a predicate device, not a study involving iterative training and testing of a machine learning model. Therefore, a distinct 'training set' in the machine learning sense is not mentioned or relevant to the described study.",
    "how_ground_truth_for_training_set_established": "Not applicable, as there is no training set described in the context of a machine learning model."
  }
}

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The INCSTAR Toxoplasma IgG ELISA kit contains instructions and materials for qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgG ELISA is of value in the determination of immunological response to infection with Toxoplasma gondii. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary or reactivated infection with Toxoplasma gondii. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.

The method for the determination of specific anti-Toxoplasma IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified Toxoplasma gondii antigen. Diluted patient serum is incubated with the purified antigen bound to the solid surface of a microtiter well. The Toxoplasma IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat antihuman IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a dual wavelength of 450 nm / 630 nm. The measured enzyme activity is directly proportional to the concentration of specific anti-Toxoplasma IqG bound to the solid phase.

{
  "acceptance_criteria_and_performance": {
    "table": {
      "Acceptance Criteria (Implicit)": [
        "Relative Sensitivity",
        "Relative Specificity",
        "Overall Agreement"
      ],
      "Reported Device Performance": [
        "98% to 100%",
        "92% to 99%",
        "96% to 99%"
      ]
    },
    "study_description": "In clinical performance studies, 300 serum samples representing 269 individuals were tested with the INCSTAR Toxoplasma IgG Kit and results were compared to those generated from the Gull Toxoplasma IgG ELISA kit. This comparison allowed for the determination of relative sensitivity, specificity, and overall agreement, demonstrating that the device meets an implied acceptance criteria if these values fall within an acceptable range, which they appear to do given the confidence intervals."
  },
  "sample_size_and_provenance": {
    "test_set_sample_size": "300 serum samples representing 269 individuals",
    "data_provenance": "The samples utilized represent a mixed population of infants, transplant patients, immunocompromised hosts, pregnant women being screened for toxoplasmosis, and patients having various other illnesses. The country of origin is not specified, but the context implies a clinical setting."
  },
  "number_and_qualifications_of_experts_for_ground_truth": "Not applicable, as ground truth was established by comparison to a cleared predicate device rather than expert consensus on individual cases.",
  "adjudication_method": "Not applicable, as ground truth was established by comparison to a cleared predicate device.",
  "mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study compares the device's performance to a predicate device, rather than human readers with and without AI assistance.",
  "standalone_performance_study": "Yes, a standalone performance study was done in the sense that the INCSTAR Toxoplasma IgG ELISA Kit's performance was evaluated independently against the predicate device. The reported sensitivity, specificity, and agreement are measures of its standalone performance in comparison to a reference standard.",
  "type_of_ground_truth": "The ground truth was established by comparison to the Gull Toxoplasma IgG ELISA kit (510(k) No. [K915891](https://510k.innolitics.com/search/K915891)), which is described as an \"FDA cleared\" and \"currently in U.S. commercial distribution\" predicate device. This implies the predicate device serves as the reference standard for defining positive and negative cases.",
  "training_set_sample_size": "Not specified. The document describes a comparison study using 300 samples, but does not detail a separate training set size for the development of the INCSTAR Toxoplasma IgG ELISA Kit.",
  "how_training_set_ground_truth_established": "Not specified. The document focuses on the performance study of the completed device against a predicate, rather than the development or training phase of the device."
}

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The INCSTAR Toxoplasma IgG "fast" ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IqG "fast" ELISA test is of value in the determination immunological response to infection with Toxoplasma gondii. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary or reactivated infection with Toxoplasma gondii. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.

The method for the determination of specific anti-Toxoplasma IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified Toxoplasma gondii antigen. Diluted patient serum is incubated with the purified antigen bound to the solid surface of a microtiter well. The Toxoplasma IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat antihuman IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a dual wavelength of 450 nm / 630 nm. The measured enzyme activity is directly proportional to the concentration of specific anti-Toxoplasma IgG bound to the solid phase.

This is an ELISA kit, not an AI device. The questions are not applicable. I will extract the available information.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: 294 serum samples representing 263 individuals. The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated, but the samples represented a mixed population including infants, transplant patients, immunocompromised hosts, pregnant women being screened for Toxoplasmosis, and patients with various other illnesses.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" was established by comparison to a legally marketed predicate device (Gull Toxoplasma IgG ELISA, K915891), not by expert opinion.

3. Adjudication method for the test set: Not applicable. The comparison was against a predicate device.

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: Not applicable. This is an ELISA kit, not an AI device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is an ELISA kit, not an AI device. The performance reported is that of the assay.

6. The type of ground truth used: Comparison with the results generated from the legally marketed predicate device, the Gull Toxoplasma IgG ELISA (K915891).

7. The sample size for the training set: Not applicable. This is an immunoassay kit, not a machine learning model where a "training set" would be used in the same context. The device's performance characteristics are established through validation studies.

8. How the ground truth for the training set was established: Not applicable.

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The INCSTAR Rubella IgG "fast" ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Rubella IgG "fast" ELISA test is of value in the determination of rubella immunological status. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of current or recent infection with rubella.

The INCSTAR Rubella IgG "fast" ELISA test kit utilizes the ELISA technique for the detection of rubella IgG antibodies. Diluted patient serum is incubated with purified rubella antigen bound to the solid surface of a microtiter well. If IgG antibodies to rubella are present in the patient's serum, antigen-antibody complexes are formed. These complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgG antibodies to rubella antigen present in the reaction solution.

This document describes the safety and effectiveness of the INCSTAR Rubella IgG "fast" ELISA Kit by comparing it to a previously cleared device. The study is a retrospective analysis of human serum samples.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states the device is "substantially equivalent" to a predicate device, implying that the acceptance criteria are met if its performance is comparable to the predicate device within acceptable statistical bounds.

2. Sample Size and Data Provenance:

• Test Set Sample Size: 497 serum samples.
• Data Provenance: The samples were from a mixed population of clinical patients (non-rubella disease related), newborns, employee/student screenings, and pregnant women. The country of origin is not explicitly stated, but given the 510(k) submission to the FDA, it is highly likely the data includes samples collected in the United States. The study is retrospective, as it compares the performance of a new kit against an existing one using collected samples.

3. Number of Experts and Qualifications:

• Not Applicable. This study is a diagnostic device performance study comparing two ELISA kits using human serum samples. The ground truth is established by the results of a predicate device and a third reference assay, not by expert interpretation of clinical data in the traditional sense of medical imaging or clinical diagnosis.

4. Adjudication Method for the Test Set:

• The primary comparison was between the INCSTAR Rubella IgG "fast" ELISA Kit and the Rubella IgG Clin-ELISA kit (the predicate device).
• For discrepant results between these two assays, a third commercial Rubella IgG EIA (Abbott Rubazyme EIA) was used for "further resolution." This acts as an adjudication step, though not explicitly a consensus panel. For example:
  • 5 samples were positive by INCSTAR but negative by the reference ELISA; 3 of these were found positive by Rubazyme.
  • 3 samples were negative by INCSTAR but positive by the reference ELISA; 2 of these were found negative by Rubazyme.

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

• No. This is a diagnostic assay comparison, not an MRMC study involving human readers interpreting clinical cases.

6. Standalone Performance:

• Yes, in the context of a diagnostic kit. The reported performance metrics (relative sensitivity, relative specificity, overall agreement) reflect the standalone performance of the INCSTAR Rubella IgG "fast" ELISA Kit when compared against the defined "ground truth" (the predicate device and the adjudicating third assay).

7. Type of Ground Truth Used:

• The ground truth in this study is based on the results of a predicate device (Rubella IgG Clin-ELISA kit), supplemented by a third commercial Rubella IgG EIA (Abbott Rubazyme EIA) for resolving discrepant cases. This is a common method for establishing "ground truth" in diagnostic kit comparisons, where a well-established and cleared assay serves as the reference.

8. Sample Size for the Training Set:

• Not explicitly stated in this summary. This document describes a clinical performance study for validation and comparison, not the development process. Therefore, information about the training set used during the development of the INCSTAR Rubella IgG "fast" ELISA Kit is not provided here.

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

• Not explicitly stated in this summary. As per point 8, this document focuses on the validation study. The method for establishing ground truth during the original development and training phases of the kit would not typically be included in a 510(k) summary focused on clinical performance data.

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The INCSTAR Rubella IgG ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme-linked immunosorbent assay (ELISA) - all technique. When performed according to instructions, the Rubella IgG ELISA test is of value in the determination of rubella immunological status. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of current or recent infection with rubella.

The INCSTAR Rubella IgG ELISA test kit utilizes the ELISA technique for the detection of rubella IgG antibodies. Diluted patient serum is incubated with purified rubella antigen bound to the solid surface of a microtiter well. If IgG antibodies to rubella are present in the patient's serum, antigen-antibody complexes are formed. These complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgG antibodies to rubella antigen present in the reaction solution.

Here's an analysis of the provided text regarding the acceptance criteria and study for the INCSTAR Rubella IgG ELISA Kit:

It's important to note that this document is a 510(k) Summary of Safety and Effectiveness from 1996. The level of detail and specific reporting requirements for device studies have evolved significantly since then. Therefore, some of the requested information, particularly regarding ground truth establishment and MRMC studies, is not explicitly present in this summary.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: 497 serum samples, representing 497 individuals.
   • Data Provenance: The samples utilized represented a "mixed population of clinical patients (nonrubella disease related), newborns, employee/student screenings, and pregnant women." The country of origin is not explicitly stated, but given it's an FDA submission, it's highly probable the samples were collected in the United States. The collection method (retrospective or prospective) is not specified, but for a 510(k) submission of this era, retrospective collection of banked samples would be common.

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

   • Not explicitly stated. The "ground truth" in this context is established by comparison to a legally marketed predicate device (Rubella IgG Clin-ELISA Kit, K860145) and, for discrepant samples, a commercial Rubella IgG EIA (Abbott Rubazyme EIA, K885297). The performance of these reference devices presumes their own validation and established accuracy, but no human expert ground truth establishment is detailed for the test samples themselves.

3. Adjudication Method for the Test Set:

   • Not explicitly stated. The comparison is directly between the INCSTAR device and the reference ELISA kit. For discrepant samples, a third commercial EIA product (Abbott Rubazyme EIA) was used for "further resolution." This acts as a form of tie-breaking or verification for discordant results, analogous to a 2+1 adjudication if the primary two disagree, but it's not a human expert adjudication in the traditional sense.

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. This is an in vitro diagnostic (IVD) device for serological testing, not an imaging or AI-assisted diagnostic, so MRMC studies involving human readers and AI assistance are not applicable in this context.

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

   • Yes, effectively. The study described here is a standalone performance study. The INCSTAR Rubella IgG ELISA Kit itself is an assay, and its performance (sensitivity, specificity, agreement) is evaluated independently against a comparator. While technical staff perform the ELISA, the interpretation of the results as positive/negative/semi-quantitative is based on optical density readings and predefined cutoff values, making it an "algorithm only" type of evaluation in the sense that human subjective interpretation of results is minimized after the initial lab work.

6. The Type of Ground Truth Used:

   • Reference standard/comparator assay. The primary "ground truth" used for evaluating the INCSTAR device was the results generated from the "Rubella IgG Clin-ELISA kit" (K860145), which is a legally marketed predicate device. For discrepant samples, a second commercial Rubella IgG EIA (Abbott Rubazyme EIA, K885297) was used as an additional reference. This is a common approach for IVD devices seeking substantial equivalence.

7. The Sample Size for the Training Set:

   • Not applicable/Not explicitly stated for a traditional "training set" in the context of an algorithm or AI. This is a laboratory assay. The development and internal calibration of such kits would involve various internal studies (e.g., linearity, precision, cross-reactivity) using various samples, but these are not typically referred to as a "training set" for a classical algorithm. The 497 samples were for the clinical performance evaluation/validation.

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

   • Not applicable, as there isn't a "training set" in the sense of predictive modeling. The development of the assay, including establishing cutoff values and calibrators, would have been based on extensive internal studies using characterized samples, likely with confirmed rubella status (positive/negative) determined by a combination of established reference methods, clinical history, and often, panels of characterized serum samples. This process is usually part of the manufacturer's R&D and internal validation, which precedes the 510(k) submission. The summary does not provide details on this internal development process.

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The INCSTAR CMV IgM Capture ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active CMV infection. The evaluation of paired CMV IgM sera can also aid in determining the stage of active CMV infection.

The INCSTAR CMV IgM Capture ELISA test kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with mouse monoclonal antibody against human IgM (u chain specific) bound to the solid surface of a microtiter well. Patient IgM is "captured" by the surface bound antibody. The presence of patient anti-CMV IgM antibodies are then "detected" and bound by CMV antigen which is linked to an anti-CMV monoclonal antibody conjugated to horseradish peroxidase. Bound horseradish peroxidase is reacted with chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgM to CMV antigen present in the reaction solution

1. Table of Acceptance Criteria and Reported Device Performance

* The acceptance criteria are implicit in the claim of substantial equivalence to the BioWhittaker CMV CAP-M ELISA test. The reported performance falls within ranges typically considered acceptable for diagnostic assays in this context.

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

• Sample Size: 529 serum samples, representing 474 individuals.
• Data Provenance: The provenance is not explicitly stated in terms of country of origin, but the samples represent a mixed population of healthy donors, immunocompromised hosts, transplant patients, congenital CMV babies, and patients having various other illnesses. This suggests a clinical setting. The study appears to be prospective in the sense that the INCSTAR device was tested against an existing reference method, but the specific collection method for the 529 samples (e.g., whether they were newly collected for the study or retrospective samples from a biobank) is not detailed.

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

Not applicable. The ground truth was established by comparison to a predicate device, the BioWhittaker CMV CAP-M ELISA Test, and subsequently by a third commercial CMV IgM ELISA method (Gull CMV IgM ELISA) for discrepant results. This is a technical comparison rather than a human expert-driven ground truth.

4. Adjudication Method for the Test Set

A form of adjudication was performed for discrepant results:

• When results between the INCSTAR CMV IgM Capture ELISA Kit and the BioWhittaker CMV CAP-M ELISA Test disagreed, a third commercial CMV IgM ELISA method (Gull CMV IgM ELISA) was used.
• For the 21 samples where INCSTAR was positive and BioWhittaker was negative, 17 had sufficient quantity for resolution. Of these 17, 10 were found positive by Gull.
• For the 10 samples where INCSTAR was negative and BioWhittaker was positive, 9 had sufficient quantity for resolution. Of these 9, 8 were found negative by Gull.

This can be described as a two-plus-one (2+1) adjudication for discrepant samples, where the "1" is the Gull assay.

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

No. This study evaluates an in vitro diagnostic device, not an imaging or interpretation device that would typically involve human readers.

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

Yes, this was a standalone performance study. The INCSTAR CMV IgM Capture ELISA Kit's performance was evaluated purely based on its analytical output compared to a reference method, without human interpretation as part of its primary function.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a predicate device (BioWhittaker CMV CAP-M ELISA Test), supplemented by a second predicate device (Gull CMV IgM ELISA) for discrepant resolution. This is a technical ground truth based on established diagnostic assays rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a study for a diagnostic kit, not a machine learning algorithm requiring a separate training set. The device's performance characteristics are based on its inherent biochemical properties and manufacturing.

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

Not applicable, as there is no training set in this context.

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The INCSTAR 25-Hydroxyvitamin D 1251 RIA Kit is intended for the quantitative measurement of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency.

This assay requires serum or plasma samples to be extracted with acetonitrile to free vitamin D and its metabolites which are almost completely associated with binding proteins as well as remove lipids which would interfere with the assay. Calibrators (kit standards) containing known concentrations of 25hydroxycholecalciferol (25-OH Vitamin D3) in a human serum matrix are likewise extracted. The primary antibody (goat anti-25-OH vitamin D) selected for use in the assay demonstrates high affinity and equal cross-reactivity to both 25(OH)D2 and 25(OH)Da but very low cross-reactivity to non-hydroxylated vitamin D2 or D3 and 1.25(OH)2 D. The primary antiserum used in the assay does recognize several other dihvdroxylated metabolites of vitamin D; however, these metabolites are found in relatively low concentrations in the circulation and are believed to be of minor biological importance. During the assay reaction, samples compete with an 1251 labeled analog of 25-OH D3 for binding sites on the primary antiserum. Phase separation is accomplished using a donkey anti-goat, polyethylene glycol precipitating reagent. The amount of radioactivity contained in the resulting precipitate is inversely proportional to the concentration of 25-OH-D present in the sample.

The provided text describes the INCSTAR 25-Hydroxyvitamin D 125I RIA Kit, a device intended for the quantitative measurement of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum or plasma.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to established methods (HPLC and CPBA) and the achievement of strong correlation coefficients. While explicit numerical thresholds for acceptance are not stated as "acceptance criteria," the reported performance demonstrates "substantial equivalence" to these methods.

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

• Study 1:
  • Test Set Sample Size: 72 serum samples (36 from each of two external sites).
  • Data Provenance: Not explicitly stated, but "various patient groups" and "external sites" suggest real-world, likely retrospective, human data. The country of origin is not mentioned.
• Study 2:
  • Test Set Sample Size: 106 serum samples.
  • Data Provenance: Not explicitly stated, but "one external site" and "various patient groups" suggest real-world, likely retrospective, human data. The country of origin is not mentioned.

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

This information is not provided in the given text. The "ground truth" for the test set is established by comparison to existing, accepted methods (HPLC and CPBA), which are themselves laboratory techniques rather than expert human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is established by quantitative laboratory methods (HPLC and CPBA), not by expert consensus requiring adjudication.

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

An MRMC comparative effectiveness study was not done. This device is a quantitative assay (RIA kit) for measuring a biomarker, not an AI-assisted diagnostic imaging tool that would involve human readers.

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

This is a standalone device in the sense that its performance is measured independently against reference methods. It's a laboratory assay that produces a quantitative result; there isn't a "human-in-the-loop" component in its direct operation or interpretation that would typically apply to AI/imaging diagnostics. Its performance is the algorithm's (assay's) performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is measurement by established laboratory methods, specifically:

• High-Pressure Liquid Chromatography (HPLC)
• Competitive Protein Binding Assay (CPBA)
  These are considered established and accepted methods for determining 25-OH-D levels.

8. The Sample Size for the Training Set

The text does not provide information about a separate "training set" in the context of machine learning. This is a traditional in vitro diagnostic (IVD) kit, not an AI/ML device that requires a distinct training phase in the same way. The development and validation of the kit itself would have involved extensive R&D, but the concept of a "training set" as defined for AI is not applicable here.

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

As noted above, the concept of a "training set" in the AI/ML sense is not directly applicable to this type of device based on the provided text. The kit's internal components (e.g., antibody specificity, assay conditions) would have been developed and optimized against known standards and characterized samples, but this is part of the product development rather than a ground truth establishment for a training set in the AI context.

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The INCSTAR Herpes Simplex Virus I/II IgG "fast" ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the INCSTAR Herpes Simplex Virus I/II IgG "fast" ELISA test is of value in the determination of immunological response to infection with HSV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection with herpes simplex virus.

The method for the determination of specific anti-HSV type 1 and/or type 2 IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified HSV type 1 and type 2 antigens. Diluted patient serum is incubated with the purified HSV antigens bound to the solid surface of the microtiter well. The HSV type 1 and/or type 2 IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat anti-human IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a wavelength of 450 nm. The measured enzyme activity is directly proportional to the concentration of specific anti-HSV IgG bound to the solid phase.

The provided text describes the INCSTAR HSV I/II IgG "fast" ELISA Kit, which is intended for the qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum.

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

Strict acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the device's performance is presented relative to a predicate device. The general "acceptance criteria" can be inferred as achieving comparable or superior performance to the predicate devices.

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

• Sample Size: 305 serum samples, representing 305 individuals.
• Data Provenance: Not explicitly stated regarding country of origin. The samples represented "a mixed population of healthy individuals, transplant patients, and patients with various illnesses." The study appears to be a retrospective comparison study, as the INCSTAR kit results were compared to "results generated from the Herpes 1 IgG Clin-ELISA and Herpes 2 IgG Clin-ELISA kits," implying these results were already established or run in parallel.

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

The concept of "experts" establishing ground truth in the traditional sense for a diagnostic test like an ELISA is not directly applicable here. The "ground truth" for the performance study was established by comparison to existing, cleared predicate devices (Herpes 1 IgG Clin-ELISA and Herpes 2 IgG Clin-ELISA kits).

For discrepant results, a "commercial HSV IgG IFA" (Immunofluorescence Assay) was used for further resolution. The expertise of those who performed or interpreted the IFA is not specified.

4. Adjudication Method for the Test Set

The primary comparison was against the predicate ELISA assays. For discrepant results (samples where the INCSTAR assay disagreed with the predicate assays), "further resolution of discrepant results by a commercial HSV IgG IFA" was performed. This implies a form of adjudication by a third, presumably more definitive, method (IFA). There's no mention of multiple human readers or a specific consensus method for interpreting the IFA results.

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

No, an MRMC comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting cases with and without AI assistance to measure improvement in human performance. The INCSTAR device is a laboratory diagnostic kit, not an AI-assisted diagnostic tool for human interpretation.

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

Yes, the performance study describes the standalone performance of the INCSTAR HSV I/II IgG "fast" ELISA Kit. This means the device's results were generated independently and then compared to the predicate devices. ELISA kits inherently operate as standalone systems, providing a result without requiring continuous human-in-the-loop interpretation once the assay is run and read by a photometer.

7. The Type of Ground Truth Used

The primary "ground truth" for the initial performance metrics (relative sensitivity, specificity, and overall agreement) was established by comparison against predicate ELISA devices that were already cleared by the FDA. For discrepant samples, a commercial HSV IgG IFA served as a higher-level "ground truth" for resolution.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI components. This is a traditional in-vitro diagnostic (IVD) kit. Therefore, the concept of a "training set" for an algorithm is not applicable.

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

As no training set is mentioned or applicable to this type of device, this question is not relevant.

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Not Found

Not Found

I apologize, but the provided text segments are either in a non-English language (Khmer, Arabic, Hindi, Japanese as identified by optical character recognition) or contain a lot of noise and fragmented characters that prevent me from understanding the content.

Therefore, I cannot extract any information related to acceptance criteria, device performance, study details, expert qualifications, or ground truth establishment to answer your request.

If you can provide the input in a clear, English-readable format, I would be happy to assist you in describing the acceptance criteria and study details.

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The INCSTAR CMV IgG ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to cytomegalovirus in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgG ELISA test is of value in the determination of immunological response to infection with CMV. The evaluation of parred sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection, reactivated infection, or reinfection with cytomegalovirus.

The INCSTAR CMV IgG ELISA test kit utilizes the enzyme-linked immunosorbant assay (ELISA) technique for the detection of cytomegalovirus IgG antibodies. Polystyrene microtiter wells are coated with purified CMV antigen. Diluted patient serum is incubated with purified CMV antigen bound to the solid surface of a microtiter well. The CMV antibodies that are present in the patient's serum will be captured by the solid phase. After washing, these complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen (tetramethylbenzidine), resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgG antibodies to CMV antigen present in the reaction solution.

{
  "acceptance_criteria_and_performance": {
    "table": [
      {
        "criterion": "Relative Sensitivity",
        "acceptance_range": "99% to 100%",
        "reported_performance": "99% to 100%"
      },
      {
        "criterion": "Relative Specificity",
        "acceptance_range": "96% to 99%",
        "reported_performance": "96% to 99%"
      },
      {
        "criterion": "Overall Agreement",
        "acceptance_range": "90% to 100%",
        "reported_performance": "90% to 100%"
      }
    ]
  },
  "study_details": {
    "sample_size_test_set": "308 serum samples representing 296 individuals",
    "data_provenance": "Mixed population of healthy donors, immunocompromised hosts, transplant patients, and patients having various other illnesses. (Country of origin not specified, retrospective implied as samples were collected and then tested)",
    "num_experts_ground_truth": "Not applicable, ground truth established by comparison to a predicate device (GULL CMV IgG ELISA Test) and a commercial CMV IgG ELISA for discrepant results.",
    "qualifications_experts": "Not applicable",
    "adjudication_method": "Discrepant results between the INCSTAR CMV IgG ELISA Kit and the GULL CMV IgG ELISA Test were resolved by a commercial CMV IgG ELISA.",
    "mrmc_comparative_effectiveness_study": "No, this was a device-to-device comparison, not a human reader study.",
    "standalone_performance": "Yes, the study describes the performance of the INCSTAR CMV IgG ELISA Kit in comparison to a predicate device.",
    "type_of_ground_truth": "Comparison to a predicate device (GULL CMV IgG ELISA Test) and a commercial CMV IgG ELISA for resolving discrepancies.",
    "sample_size_training_set": "Not specified; this is likely a locked-down assay, not a machine learning model requiring training data from the clinical study perspective.",
    "how_ground_truth_training_set_established": "Not applicable (as above)."
  }
}

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