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The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a single use, unitized immunochromatographic test that uses recombinant B. burgdorferi antigens for the qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood. This test should be used only in patients with history, signs and symptoms that are consistent with Lyme disease. The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is intended for use in clinical and physicians' office laboratories.

The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a Class II in vitro diagnostic device that utilizes standard immunochromatographic chromophore technology to qualitatively detect, in serum or whole blood, the presence of IgG and IgM antibodies to recombinant Borrelia burgdorferi antigens, as an aid in the diagnosis of Lyme Disease. It consists of a plastic housing, containing an absorbent material that collects the specimen and, with the addition of buffer, delivers it and adjacent adsorbed reagents, onto a chromatographic strip, onto which recombinant test antigen and control antibodies have been adsorbed within their respective test and control detection zones. As the mixture migrates along the strip, gold-conjugated antibodies specific for human IgG and IgM bind to the antibodies in the specimen. Antibodies specific for Borrelia burgdorferi antigens, if present, will bind to the adsorbed recombinant antigens in the test zone, resulting in a visually detectable colored line due to the presence of goldconjugated antibodies, which are bound to the specimen antibodies. If no antibodies to Borrelia burgdorferi are present, no line will appear in the test zone. A line will always appear in the control zone, indicating a valid result, as goat anti-human IgG antibodies adsorbed in the control zone bind excess IgG in the specimen, which have been bound to the gold-conjugate.

The provided text describes a medical device, the Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay, but does not contain the detailed acceptance criteria or the study data that proves the device meets specific performance criteria. The document is a 510(k) summary for regulatory submission, focusing on device description, intended use, and substantial equivalence to a predicate device, rather than a full study report with detailed results.

Therefore, I cannot populate the requested table with acceptance criteria and reported device performance, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about the training set.

The document mainly focuses on establishing the device's functionality and its substantial equivalence to another device (Wampole Borrelia burgdorferi IgG/IgM ELISA) for regulatory approval.

What information is available in the provided text:

• Device Name: Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay
• Intended Use: Qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood using recombinant B. burgdorferi antigens. It's intended for patients with a history, signs, and symptoms consistent with Lyme disease, and for use in clinical and physicians' office laboratories.
• Predicate Device: Wampole Borrelia burgdorferi IgG/IgM ELISA (510(k) Document Control Number: K965131)
• Technology: Immunochromatographic in vitro diagnostic device, utilizing recombinant Borrelia burgdorferi antigens.
• Claimed Advantages of Recombinant Antigens: Improved specificity and a continued supply of high-quality, uniform antigen.

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An OTC hCG Pregnancy Test for home use intended for the early detection of pregnancy. It is intended to measure hCG, a placental hormone, in urine sample.

The Sure Check™ Pregnancy Test is a self contained immunochromatographic test designed for use in detecting hCG in urine samples. After the person wets the wick in the device the urine is absorbed and transferred to a pad where a labelled colloidal gold containing a monoclonal antibody directed against beta hCG is present. If the antigen (hCG) is present, an antigen/antibody reaction takes place forming a complex. This migrates along the nitrocellulose support to the Test Line which is printed on the membrane. This is another antibody, in this case a monoclonal anti-hCG antibody, which captures the colored complex when it passes over the immobilized test line antibody. As the complex adheres to the capture antibody a visible light to dark purple band appears indicating a positive test result. The remaining complex travels further along the membrane to another immobilized control antibody. This captures the remaining complex forming another purple band indicating that the test has been performed properly.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Sure Check™ Pregnancy Test Performance vs. Predicate Device (Chembio HCG STAT-PAK)",
    "headers": ["Metric", "Acceptance Criteria", "Reported Sure Check™ Performance"],
    "rows": [
      ["Early Detection of Pregnancy", "Not explicitly stated, but implied to be comparable to predicate", "Effective in diagnosing pregnancy"],
      ["Accuracy (vs. Predicate Device)", "Comparable to predicate device", "Demonstrated substantial equivalence"],
      ["Sensitivity/Detection Limit", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #6a)"],
      ["Specificity", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #7b)"],
      ["Interfering Substances", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #8c)"],
      ["Time Study for Holding Device in Urine Stream", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #9d)"],
      ["Optimal Reaction Time", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #10e)"],
      ["Reproducibility", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #11f)"],
      ["Linearity", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #12g)"]
    ]
  },
  "sample_size_test_set": "Not specified in the provided text. The document refers to \"clinical trials\" and \"Comparative Study Data\" (Exhibit #3) but does not provide the exact sample size.",
  "data_provenance": "The clinical trials were conducted by Target Health Inc. in New York, NY. The data appears to be prospective, collected for the purpose of the study (an \"Open Study to Evaluate the Ability of Sure Check™ to Determine Pregnancy\"). The country of origin for the data is the USA.",
  "number_of_experts_ground_truth_test_set": "Not specified. The ground truth for the clinical trials was established by comparison to a \"currently marketed device (Professional Use)\", the Chembio HCG STAT-PAK, K#923925/A. It's not explicitly stated that experts established the ground truth for individual cases, but rather a professional-use device served as the reference standard.",
  "qualifications_experts_ground_truth_test_set": "Not applicable, as expert involvement in establishing ground truth for individual cases is not specified. The reference standard was a professional-use device.",
  "adjudication_method_test_set": "Not applicable/Not specified. The study compared the Sure Check™ to a predicate device; it doesn't mention a specific adjudication method for discrepancies between test results and a true ground truth if that ground truth itself was established by human readers.",
  "mrmc_comparative_effectiveness_study": "No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study compares the new device (Sure Check™) to a predicate device (Chembio HCG STAT-PAK) in clinical trials for accuracy. It's a device-to-device comparison, not an evaluation of human readers' improvement with or without AI assistance.",
  "standalone_performance_done": "Yes, a standalone performance study was done for the device. The clinical trials evaluate the device's accuracy in diagnosing pregnancy. The non-clinical tests (Sensitivity/Detection Limit, Specificity, etc.) also assess the device's inherent performance characteristics.",
  "type_of_ground_truth_used": "The ground truth for the clinical trials was established by correlation with a currently marketed professional-use device, the Chembio HCG STAT-PAK. This implies that the results of the predicate device were considered the reference standard for truth in diagnosing pregnancy.",
  "sample_size_training_set": "Not applicable. This device is an immunochromatographic test, not an AI/ML algorithm that requires a training set in the conventional sense.",
  "how_ground_truth_training_set_established": "Not applicable, as this device does not use an AI/ML algorithm that requires a training set with established ground truth."
}

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