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Syntron's QuikStrip One Step Benzodiazepine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Benzodiazepine in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's QuikStrip One Step Benzodiazepine Test is not intended to monitor drug levels, but only to screen urines for the presence of Benzodiazepine and its metabolites:

Syntron's QuikStrip One Step Benzodiazepine Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 200 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "The submission does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets). Instead, it presents the device's performance metrics from an internal study and a clinical trial. However, the FDA's acceptance of the 510(k) submission implies that these reported performances were deemed sufficient for substantial equivalence.",
    "Reported Device Performance (Internal Testing)": {
      "Relative Sensitivity (agreement within positive samples)": "1.000 (100%)",
      "Relative Specificity (agreement within negative samples)": "0.9740 (97.40%)",
      "Accuracy": "98.54%"
    },
    "Reported Device Performance (Clinical Trial)": {
      "Relative Sensitivity": "100%",
      "Relative Specificity": "95.42%",
      "Accuracy": "97.69%"
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": {
    "Test Set Sample Size": "303 samples (for the clinical trial)",
    "Data Provenance": "The document does not specify the country of origin of the data. It mentions 'Clinical Trial' which typically implies prospective data collection, even if the samples themselves might be collected over time. No explicit statement about retrospective or prospective is given for the 303 samples, but 'clinical trial' strongly suggests prospective."
  },
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "The ground truth for the test set was established using Gas Chromatography/Mass Spectrophotometry (GC/MS) for all positive samples from either screening method. GC/MS is a laboratory analytical technique and typically does not involve 'experts' in the same way as medical imaging interpretation. The document does not specify the number or qualifications of personnel operating the GC/MS or interpreting its results, assuming standard laboratory protocols.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable in the conventional sense for this type of test. The ground truth (presence/absence of benzodiazepines above a certain cutoff) was determined by GC/MS, an objective analytical method. There's no indication of multiple readers or an adjudication process for the GC/MS results themselves.",
  "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable. This is a standalone diagnostic test (QuikStrip) and not an AI-assisted interpretation tool for human readers. There is no mention of a human-in-the-loop component or a MRMC study.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, standalone performance was done. The QuikStrip One Step Benzodiazepine Test is a qualitative immunoassay designed to provide a direct visual result (presence or absence of a color band) without human interpretation beyond reading the band. The presented sensitivity, specificity, and accuracy are for the device's performance on its own.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth was established by Gas Chromatography/Mass Spectrophotometry (GC/MS). This is an objective analytical method considered the 'gold standard' for confirming the presence and concentration of drugs and their metabolites.",
  "8. The sample size for the training set": "The document does not explicitly state a 'training set' sample size. It refers to 'in-house testing' and a 'clinical trial'. For the performance evaluation, 303 samples were used in the clinical trial. The device mechanism (competitive binding immunoassay) is not typically 'trained' in the same way a machine learning algorithm is.",
  "9. How the ground truth for the training set was established": "As there is no explicitly defined 'training set' for a machine learning model, this question is not directly applicable. For the samples used in the performance evaluation (in-house and clinical trial), the ground truth for benzodiazepine presence and concentration was established by GC/MS."
}

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