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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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