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

The trade name of the device is QuikPac II One Step Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a class II device per 21 CFR paragraph 862.3100. Syntron's QuikPac II One Step Amphetamine 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.

Here is the analysis of the provided text regarding the QuikPac II One Step Amphetamine Test:

Acceptance Criteria and Device Performance Study

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" because the document states the device yielded these percentages, suggesting these met the sponsor's internal thresholds for acceptable performance. The target detection level is 500 ng/ml.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 308 samples were used in the clinical trial.
• Data Provenance: The document does not explicitly state the country of origin. It describes "in-house testing" which often implies samples collected or processed by the manufacturer, followed by a "clinical trial." The nature of the samples being compared to Syva EMIT® II and GC/MS suggests they are human urine samples. It is a retrospective analysis in that the samples already had existing results from EMIT® II and were subsequently confirmed by GC/MS.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth for positive samples by either screening method (QuikPac II or EMIT® II) was confirmed by GC/MS, which is a laboratory analytical technique rather than a human expert interpretation. For the discrepant samples, GC/MS identified the specific interfering substances.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated as a formal multi-reader adjudication process. However, the document describes a clear hierarchical adjudication:
  1. Initial screening by QuikPac II and EMIT® II.
  2. Any sample positive by either screening method was then confirmed by GC/MS. This acts as the final arbiter for true positivity.
  3. Discrepant samples (positive by screening, negative by GC/MS) were further analyzed by GC/MS to identify interfering substances.

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

• Was an MRMC study done? No. This device is an in-vitro diagnostic test, not an imaging or interpretation system requiring human readers. Therefore, an MRMC study is not applicable.
• Effect size of human readers with/without AI assistance: Not applicable, as there are no human readers involved in the interpretation of this device's output.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes. The entire description of the clinical trial and in-house testing refers to the performance of the QuikPac II device itself, without human interpretation beyond reading the color bands (which is a direct output of the device's biochemical reaction). The device provides a direct positive or negative result.

7. Type of Ground Truth Used

• Type of Ground Truth: Gold Standard Laboratory Confirmation (GC/MS) for all positive samples and for identifying interfering substances in discrepant samples. GC/MS (Gas Chromatography/Mass Spectrometry) is a highly accurate and widely accepted method for confirming the presence and concentration of drugs and metabolites.

8. Sample Size for the Training Set

• Sample Size: Not explicitly stated as a separate training set. The "in-house testing" mentioned might have involved some form of internal development and testing, analogous to a training or validation set. However, the document only explicitly reports the results of the final "clinical trial" of 308 samples as the primary performance evaluation. It's common for IVD devices to have internal validation performed by the manufacturer, which would implicitly involve data for training/optimization, but this data is not detailed as a distinct "training set" with its size specified.

9. How Ground Truth for the Training Set was Established

• How Ground Truth was Established: Not explicitly detailed for a training set. However, based on the approach for the test set, it is highly probable that any internal development or optimization (analogous to training) would have also relied on GC/MS confirmation for ground truth where applicable. The statement "documented to be positive by GC/MS" for in-house testing samples supports this.

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