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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.,

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