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The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzodiazepines in human urine at a cut-off concentration of 300 ng/mL set relative to oxazepam, a major metabolite of benzodiazepines. They are intended for healthcare professionals including professionals at point of care sites.

The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Benzodiazepines in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Benzodiazepines in urine at a cut-off concentration of 300 ng/mL. These tests can be performed without the use of an instrument.

A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Benzodiazepines at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred,

{
  "acceptance_criteria": {
    "device_performance_table": [
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Positive Agreement",
        "reported_performance": "90% (95% CI: 84% - 95%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Negative Agreement",
        "reported_performance": "97% (95% CI: 93% - 99%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Overall Agreement",
        "reported_performance": "94% (95% CI: 91% - 96%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Device vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Positive Agreement",
        "reported_performance": "90% (95% CI: 84% - 94%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Device vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Negative Agreement",
        "reported_performance": "97% (95% CI: 92% - 99%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Device vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Overall Agreement",
        "reported_performance": "94% (95% CI: 90% - 96%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. GC/MS - Positive Agreement",
        "reported_performance": "97% (95% CI: 92% - 99%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. GC/MS - Negative Agreement",
        "reported_performance": "95% (95% CI: 91% - 98%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. GC/MS - Total Agreement",
        "reported_performance": "96% (95% CI: 93% - 98%)"
      },
      {
        "criterion": "ACON BZO One-Step Benzodiazepines Test Device vs. GC/MS - Positive Agreement",
        "reported_performance": "96% (95% CI: 92% - 98%)"
      },
      {
        "criterion": "ACON BZO One-Step Benzodiazepines Test Device vs. GC/MS - Negative Agreement",
        "reported_performance": "96% (95% CI: 92% - 99%)"
      },
      {
        "criterion": "ACON BZO One-Step Benzodiazepines Test Device vs. GC/MS - Total Agreement",
        "reported_performance": "96% (95% CI: 94% - 98%)"
      }
    ],
    "study_details": {
      "test_set_sample_size": 300,
      "data_provenance": "Clinical urine specimens, retrospective (implied by the nature of clinical evaluation and GC/MS retrospective analysis)",
      "number_of_experts_ground_truth": "Not specified, but the comparison is against another FDA-cleared device and Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which serves as the gold standard.",
      "qualification_of_experts": "Not specified, as the ground truth is established by objective methods (GC/MS) and comparison to a predicate device.",
      "adjudication_method": "Not applicable, as the ground truth is established by objective methods (GC/MS) and comparison to a predicate device rather than human consensus.",
      "mrmc_comparative_effectiveness_study": "No, this was not a multi-reader multi-case (MRMC) comparative effectiveness study, as it did not involve human readers interpreting images with and without AI assistance.",
      "standalone_performance_study": "Yes, a standalone performance study was conducted comparing the device against Gas Chromatography/Mass Spectrometry (GC/MS) at the cutoff of 300 ng/ml. This represents the algorithm's (device's) performance without human intervention in the result interpretation.",
      "type_of_ground_truth_test_set": "Gas Chromatography/Mass Spectrometry (GC/MS) analysis at the cutoff of 300 ng/ml.",
      "training_set_sample_size": "Not specified in the provided document. The study describes a clinical evaluation using a test set, but does not detail the training set for the device's development.",
      "how_ground_truth_for_training_set_established": "Not specified in the provided document, as training data and how its ground truth was established are not described."
    }
  }
}

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