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The ACON OPI II One Step Opiate Test Strip or the ACON OPI II One Step Opiate Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of opiates in human urine at a cut-off concentration of 2,000 ng/mL. It is a prescription use device intended for healthcare professionals including those at the point of care sites.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The ACON OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Opiate in a urine sample. The test is based on the principle of antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Opiate and its metabolite in urine at a cutoff concentration of 2,000 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 Opiate at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's a breakdown of the acceptance criteria and the study details for the ACON® OPI II One Step Opiate Test devices, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 300 clinical urine specimens.
   • Data Provenance: Clinical urine specimens. The document doesn't explicitly state the country of origin, but it references "clinical evaluation" and "clinical urine specimens," suggesting real-world samples. It is retrospective as it refers to a "clinical evaluation," implying the samples were collected prior to the evaluation.
   • Special Note: Approximately 10% of the specimens contained Opiate concentrations falling between -25% cutoff to +25% cutoff range, which is critical for assessing performance near the clinical decision point.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not specify the number of experts or their qualifications for establishing ground truth from the FDA-cleared predicate device.
   • For the GC/MS analysis (which serves as a highly definitive ground truth), it is implied that standard laboratory procedures were followed by qualified personnel, but no specific number or qualifications are provided.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not describe a specific adjudication method beyond comparing the device results to a predicate device and to GC/MS analysis. The "ground truth" for the GC/MS comparison is the GC/MS result itself, which is a definitive chemical analysis rather than an expert consensus process that would typically require adjudication.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test, not an AI-assisted diagnostic tool that would typically involve human readers interpreting imaging or complex data with and without AI assistance. The test results are visual and qualitative, read directly from the test strip/device.

5. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

   • Yes, the performance presented is standalone. This device is a manual, qualitative immunoassay. The "algorithm" is the biochemical reaction and visual readout on the test strip/device, and the performance metrics directly reflect its ability to detect opiates in urine without human interpretation beyond observing the presence or absence of a line.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Primary Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is a highly definitive analytical chemical method for drug detection and quantification.
   • Secondary Comparison: An FDA-cleared Opiate test device, serving as a predicate for comparison.

7. The sample size for the training set:

   • The document does not explicitly state a training set size. This device is an immunoassay, not a machine learning or AI-based device that typically requires a distinct "training set" in the computational sense. Its "training" is inherent in its chemical design and manufacturing process. The 300 clinical urine specimens are used for "clinical evaluation" (testing), not for training an algorithm.

8. How the ground truth for the training set was established:

   • As noted above, there is no explicit "training set" in the context of machine learning. The device's inherent design and analytical validation studies (analytical sensitivity, specificity, interference, precision, etc.) establish its performance characteristics. The 300 clinical samples were used for validation/testing, with GC/MS as the ground truth reference.

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