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Beckman Coulter, Inc's Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.

The Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma.

{
  "acceptance_criteria_and_device_performance": {
    "title": "Acceptance Criteria and Reported Device Performance for Access® Ostase® Assay",
    "table": {
      "headers": ["Performance Characteristic", "Acceptance Criteria (Implicit via predicate comparison)", "Reported Device Performance"],
      "rows": [
        ["Method Comparison (Slope vs. Predicate)", "Close to 1", "0.9756"],
        ["Method Comparison (Intercept vs. Predicate)", "Close to 0", "-0.5987"],
        ["Method Comparison (Correlation r vs. Predicate)", "Close to 1", "0.9895"],
        ["Mean % Difference (Osteoporosis vs. Predicate)", "Low Percentage Difference", "-5.96%"],
        ["Mean % Difference (Paget's vs. Predicate)", "Low Percentage Difference", "-7.01%"],
        ["Between-Run %CV (Imprecision)", "Low Percentage (e.g., <10%)", "3.3% to 5.9%"],
        ["Within-Run %CV (Imprecision)", "Low Percentage (e.g., <10%)", "1.5% to 2.6%"],
        ["Total %CV (Imprecision)", "Low Percentage (e.g., <10%)", "3.6% to 6.4%"],
        ["Recovery (Spike and Recovery)", "Close to 100%", "Average 92.4% (range 89.9% to 95.3%)"],
        ["Recovery (Specimen Dilution Average)", "Close to 100%", "Average 92.2% (range 78.1% to 106.1%)"],
        ["Interference (Absence of significant interference)", "No significant interference", "No significant interference from tested substances"]
      ]
    },
    "notes": "The acceptance criteria for the Access® Ostase® Assay are implicitly defined by its substantial equivalence claim to the Tandem®-R Ostase® Assay predicate device. The reported performance data demonstrate close agreement, high correlation, and low variability, indicating that the device performs comparably to the predicate and meets general expectations for diagnostic assays."
  },
  "study_details": {
    "sample_size_test_set": {
      "method_comparison": "172 samples (88 osteoporosis, 84 Paget's)",
      "imprecision": "Across various concentrations (exact number of individual samples not specified, but multiple runs and concentrations were evaluated).",
      "recovery_spike": "15 samples",
      "recovery_dilution": "10 samples",
      "interfering_substances": "Not explicitly stated for the test set, but substances were tested at specified concentrations.",
      "data_provenance": "Not explicitly stated for the test set. However, a crucial statement indicates that all clinical studies were generated using the Tandem-R Ostase Assay (the predicate device), implying that the clinical utility data, rather than the analytical performance data, came from studies on the predicate."
    },
    "number_of_experts_ground_truth_test_set": "Not applicable; this is a quantitative immunoassay comparing a new device to a predicate device, not a qualitative diagnostic interpretation requiring expert consensus on images or similar data.",
    "qualifications_of_experts": "Not applicable.",
    "adjudication_method": "Not applicable.",
    "multi_reader_multi_case_comparative_effectiveness_study": "No, this is an in vitro diagnostic (IVD) device for quantitative measurement of a biomarker, not an imaging or interpretive device requiring human-in-the-loop assessment.",
    "standalone_performance": "Yes, the study presents the standalone performance of the Access® Ostase® Assay by comparing its measurements directly to those of the predicate device (Tandem®-R Ostase® Assay) and evaluating its analytical characteristics (imprecision, recovery, interference).",
    "type_of_ground_truth_test_set": "The 'ground truth' for the analytical performance studies (method comparison, imprecision, etc.) is the quantitative measurement provided by the established predicate device (Tandem®-R Ostase® Assay) and established analytical methodologies. For clinical utility, the 'ground truth' for indications (managing osteoporosis and Paget's disease) was established by studies performed using the predicate device, which were then referenced for the new device through the substantial equivalence pathway.",
    "sample_size_training_set": "Not applicable for this type of IVD device. The device is not based on a machine learning algorithm that requires a dedicated training set in the typical sense. Performance is established through analytical validation against a predicate.",
    "ground_truth_for_training_set_established": "Not applicable."
  }
}

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