(67 days)
The ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device are rapid chromatographic immunoassays for the qualitative detection of Opiates in urine at a cut-off concentration of 300 ng/mL for morphine. They are intended for the healthcare professional use.
The ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Opiates 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 Opiates in urine at a cut-off concentration of 300 ng/mL for morphine. 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 Opiates at the concentration wills a logan of 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.
Here's an analysis of the provided text regarding the ACON MOP One Step Opiate Test, focusing on acceptance criteria and the supporting study:
The document describes the ACON MOP One Step Opiate Test Strip and Device, which are rapid chromatographic immunoassays for the qualitative detection of Opiates in urine at a cut-off concentration of 300 ng/mL for morphine.
1. Table of Acceptance Criteria and Reported Device Performance
The specific acceptance criteria (e.g., minimum percentage agreement) are not explicitly stated as numerical targets in the provided text. However, the study aims to demonstrate "substantial equivalency" to a predicate device and "safe and effective" detection. Therefore, 100% positive agreement and high overall agreement with the predicate and GC/MS can be considered the de-facto performance goals.
| Metric (Comparison to Predicate) | ACON MOP Test Strip Performance | ACON MOP Test Device Performance |
|---|---|---|
| Positive Agreement (vs. Predicate) | 100% (98% - 100%*) | 100% (98% - 100%*) |
| Negative Agreement (vs. Predicate) | 100% (98% - 100%*) | 100% (98% - 100%*) |
| Overall Agreement (vs. Predicate) | 100% (98% - 100%*) | 100% (98% - 100%*) |
| Metric (Comparison to GC/MS) | ACON MOP Test Strip Performance | ACON MOP Test Device Performance |
|---|---|---|
| Positive Agreement (vs. GC/MS) | 100% (97% - 100%*) | 100% (97% - 100%*) |
| Negative Agreement (vs. GC/MS) | 94% (89% - 97%*) | 94% (89% - 97%*) |
| Overall Agreement (vs. GC/MS) | 97% (94% - 98%*) | 97% (94% - 98%*) |
| ** 95% Confidence Intervals |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 300 clinical urine specimens.
- 10% of these samples had Opiate concentrations in the -25% cut-off to +25% cut-off range (i.e., near the decision point).
- Data Provenance: The data is described as "clinical urine specimens," implying prospective collection from clinical settings. The country of origin is not specified, but the submitter is based in San Diego, California, USA, suggesting the data is likely from the United States. It is a retrospective clinical evaluation of previously collected samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth when comparing to the predicate device. However, for the comparison against GC/MS, the GC/MS result itself serves as the objective ground truth, which does not typically involve human expert interpretation in the same way as, for example, image interpretation. The GC/MS analysis would be performed by trained laboratory technicians/scientists, but they are not referred to as "experts" for ground truth establishment in this context.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. For the comparison against the predicate, it implies a direct comparison of results. For the comparison against GC/MS, the GC/MS result is considered the definitive truth, so adjudication is not applicable in the traditional sense.
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
No MRMC comparative effectiveness study was done. This device is a standalone immunoassay, not an AI-assisted diagnostic tool that would be used by human readers whose performance could be improved with assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was done. The performance metrics presented (Positive Agreement, Negative Agreement, Overall Agreement) represent the performance of the ACON MOP one-step tests as standalone devices, with their results being compared against both a predicate device and GC/MS. The test delivers a visual, qualitative end result without requiring external interpretation by a machine or complex algorithm that would involve human-in-the-loop processing for the initial reading.
7. The Type of Ground Truth Used
Two types of ground truth were used for the test set:
- Results from the Screener Opiate Test Drugscreen™ DIP Opiate Test (the predicate device).
- Data from Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered the gold standard for confirmatory drug testing.
8. The Sample Size for the Training Set
The document does not mention a separate training set. This is typical for simple immunoassay devices that rely on chemical reactivity rather than machine learning algorithms that require a distinct training phase. The study described is a clinical validation study rather than a model development and training study.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described for this type of device, this question is not applicable. The device's underlying principle is antigen-antibody immunochemistry, which does not involve a "training" phase for an algorithm.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).