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K Number
K964715
Device Name
PARAMAX SALICYLATE REAGENT
Manufacturer
DADE INTL., INC.
Date Cleared
1997-04-25

(151 days)

Product Code
DKJ
Regulation Number
862.3830
Type
Traditional
Panel
TX
Reference & Predicate Devices
K771805
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

The Paramax® Salicylate Reagent is based on colormetric methodology.

AI/ML Overview
{
  "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"
}

§ 862.3830 Salicylate test system.

(a)
Identification. A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.(b)
Classification. Class II.