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This device is intended for medical/forensic screening of urine.

Syntron's QuikPac II One Step Methamphetamine 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 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 500 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.

Acceptance Criteria and Device Performance Study for QuikPac II One Step Methamphetamine Test

The QuikPac II One Step Methamphetamine Test is a chromatographic absorbent device designed for the qualitative testing of urine for the presence of Methamphetamine and its metabolites.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" but presents performance metrics that would likely serve as such for a screening device. We will infer the acceptance criteria from the reported performance in both internal and clinical settings.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Internal Testing: Not explicitly stated, but performed "against Syva EMIT® II on samples documented to be positive by GC/MS." Implies a set of known positive samples.
  • Clinical Trial: 305 samples.
• Data Provenance: Not explicitly stated. The submission is from "Syntron Bioresearch, Inc." in Carlsbad, California, implying the testing likely occurred in the USA. The studies appear to be prospective for the clinical trial, as it was run to evaluate the device. The internal testing might have utilized a retrospective collection of samples previously characterized by GC/MS, but this is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable in the traditional sense of human readers interpreting images or data. This device is a diagnostic test where an objective chemical reaction determines the result.
• Qualifications of Experts: The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is considered the gold standard for confirming the presence and concentration of drugs in biological samples. The "experts" in this context would be the technicians and analysts proficient in operating and interpreting GC/MS results, although their specific qualifications (e.g., years of experience, certifications) are not provided.

4. Adjudication Method for the Test Set

• Internal Testing: Results from the QuikPac II test were compared against the Syva EMIT® II test, and any discrepancies or ultimately all positive samples were confirmed by GC/MS. This suggests an adjudication process where GC/MS acted as the definitive arbiter.
• Clinical Trial: All positive samples by either the QuikPac II or the screening method (presumably EMIT II, but not explicitly stated for the clinical trial) were confirmed by GC/MS. Discrepant samples were specifically analyzed by GC/MS to determine the true positive/negative status. This indicates a GC/MS adjudication for all positives and discrepant cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study typically applies to medical devices or AI algorithms where human readers interpret complex data (e.g., medical images). The QuikPac II is a rapid diagnostic test with a visual qualitative result, not requiring human "readers" in the MRMC sense.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The reported performance metrics (relative sensitivity, relative specificity, accuracy) were for the QuikPac II device itself, comparing its output directly against a gold standard (GC/MS) or a commonly accepted screening method (Syva EMIT® II). There is no "human-in-the-loop" component for interpreting the test strip's result beyond observing the color bands.

7. Type of Ground Truth Used

• The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS). For the internal testing, samples were "documented to be positive by GC/MS." For the clinical trial, "All positive samples by either screening method were confirmed by GC/MS." This method provides definitive chemical identification and quantification, making it a highly reliable form of ground truth.

8. Sample Size for the Training Set

• The document does not provide information on a specific "training set" sample size. This is common for this type of diagnostic device, which is typically developed through chemical formulation and optimization rather than machine learning algorithms requiring a distinct training phase with labeled data. The development process would involve iterative testing and refinement against samples, but these are not explicitly termed a "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

• As there's no explicitly defined "training set" in the AI sense, information on how its ground truth was established is not applicable. The development of the device would have involved internal validation and optimization where its performance was continually assessed against known positive and negative samples, likely confirmed by methods like GC/MS, to ensure accurate reagent concentrations and reaction kinetics.

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