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The Paramax® Salicylate Reagent is intended for use as quantitative determination of salicylate in plasma and serum.

The Paramax® Salicylate Reagent is based on colormetric methodology.

{
  "acceptance_criteria_and_performance": {
    "table": [
      {
        "criterion": "Correlation with predicate device",
        "acceptance_level": "High correlation coefficient",
        "reported_performance": "Correlation coefficient = 0.999"
      },
      {
        "criterion": "Regression equation",
        "acceptance_level": "Regression equation indicating substantial equivalence",
        "reported_performance": "Paramax® value = (1.16 x aca value) - 1.8 mg/dL"
      }
    ],
    "study_summary": "The study demonstrated substantial equivalence between the Paramax® Salicylate Reagent and the DuPont aca Salicylate Reagent based on the high correlation coefficient (0.999) and a regression equation of Paramax® value = (1.16 x aca value) - 1.8 mg/dL."
  },
  "sample_size_test_set": 49,
  "data_provenance": "Not specified (likely clinical samples, but country/retrospective/prospective not mentioned in snippet).",
  "number_of_experts_ground_truth": "Not applicable; the ground truth for this comparison study was established by the predicate device (DuPont aca Salicylate Reagent).",
  "qualifications_of_experts": "Not applicable",
  "adjudication_method": "Not applicable",
  "mrmc_comparative_effectiveness_study": "No, this was a device-to-device correlation study, not an MRMC study involving human readers.",
  "standalone_performance_study": "Yes, the study evaluated the standalone performance of the Paramax® Salicylate Reagent by comparing its results to a predicate device's results on the same samples.",
  "type_of_ground_truth": "Predicate device's results (DuPont aca Salicylate Reagent). The predicate device's measurements are considered the reference for establishing substantial equivalence.",
  "sample_size_training_set": "Not applicable; this is a device validation study, not a machine learning model training.",
  "how_ground_truth_for_training_set_established": "Not applicable"
}

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