(234 days)
The QuikScreen™ Multi (MDMA and OPI) Drug Cup Test consists of competitive binding , lateral flow immunochromatographic assays and provides a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 ng/ml and OPI at or above the cutoff level of 300 ng/ml in human urine. The device is intended for OTC and prescription use.
QuikScreen ™ Multi (MDMA and OPI) Drug Cup Test Device is a convenient specimen collection cup with a built-in strip holder, which is able to hold the Strip of MDMA and OPI within the container. The membrane of the MDMA test strip is coated with goat anti-mouse antibody and MDMA-Bovine serum albumin conjugate. The membrane of the OPI test strip is coated with goat anti-mouse antibody and OPI-Bovine serum albumin conjugate. The sample pad of the MDMA test strip contains a colloidal gold-labeled mouse monoclonal anti-MDMA antibody. The sample pad of the OPI test strip contains a colloidal gold-labeled mouse monoclonal anti-OPI antibody. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone and will not produce a magenta color band when the drug is above the detection level of drug (500ng/ml of MDMA or 300ng/ml of OPI), Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A color line will always appear at the control region. A negative specimen produces two distinct color bands in both the test line and control area. A positive specimen produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. The test is easy and fast allowing the user to read the screen for abuse of drugs without the need for any other instrumentation to determine results. The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine. If the test result shows 1 line (preliminary positive) you should send the sample for laboratory testing.
Here's a breakdown of the acceptance criteria and the study details for the QuikScreen™ Multi (MDMA and OPI) Drug Cup Test:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Acceptance Criteria (Predicate Device K121166) | Reported Device Performance (QuikScreen™ Multi) |
|---|---|---|
| Intended Use | Detect MDMA, OPI in human urine | Detect MDMA (≥500 ng/ml) and OPI (≥300 ng/ml) in human urine |
| Analytes | MDMA, OPI | MDMA, OPI |
| Technology | Monoclonal/polyclonal antibody, colloidal gold conjugate, Drug-BSA conjugate | Monoclonal/polyclonal antibody, colloidal gold conjugate, Drug-BSA conjugate |
| Cutoff (MDMA) | 500 ng/ml | 500 ng/ml |
| Cutoff (OPI) | 300 ng/ml | 300 ng/ml |
| Assay Time | 5 minutes | 5 minutes |
| Preliminary Positive Reconfirmation | Yes (by GC/MS or LC/MS) | Yes (by GC/MS or LC/MS) |
| Matrix | Urine | Urine |
| Calibrator | None | None |
| Instrument | None, visual read | None, visual read |
| Calibration of Reagent | None | None |
| Storage | Below 28°C until expiration | Below 28°C until expiration |
| Sensitivity (MDMA) | ≥500 ng/ml shows positive result | ≥500 ng/ml shows positive result |
| Sensitivity (OPI) | ≥300 ng/ml shows positive result | ≥300 ng/ml shows positive result |
| Total Precision (within/inter-lot) | No appreciable variation across 3 lots with positive and negative spiked samples | No appreciable within and inter-lot variation when testing both positive and negative spiked samples across three (3) different lots of test device at different days. (Similar to predicate) |
| Cutoff Determination (MDMA) | 50% below cutoff negative, at cutoff and 25% above cutoff positive | 50% below the cutoff level of MDMA are negative. The result set at cutoff and 25% above cutoff level of MDMA are positive. (Similar to predicate) |
| Cutoff Determination (OPI) | 50% below cutoff negative, at cutoff and 25% above cutoff positive | 50% below the cutoff level of OPI are negative. The result set at cutoff and 25% above cutoff level of OPI are positive. (Similar to predicate) |
| Accuracy | Good correlation with reference methods | A comparison study of positive and negative specimens or lay user study with reference methods were performed, the test results was correlated very well with reference methods. (Similar to predicate). Cross-interference study indicated no cross-interference between MDMA/OPI and 11 other drugs in the multi-drug cup. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For Total Precision and Cutoff Determination, "positive and negative spiked samples across three (3) different lots of test device" were used. Specific numbers are not provided, but it implies a statistically significant sample to assess reproducibility.
- For Accuracy, "positive and negative specimens" were used. A specific number is not provided, but the statement "correlated very well" implies a sufficient sample for comparison.
- For Cross-interference study, "MDMA (500ng/ml cutoff), OPI (300ng/ml cutoff) Strip into the QuikScreen™ Multiple 11 drug cup device" was used. The number of samples tested for cross-interference is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the context of manufacturing in Tianjin, China (Submitter address), it's likely the studies were conducted there. The samples are human urine.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention the use of experts to establish ground truth in the traditional sense (e.g., interpreting results).
- Instead, reference methods (GC/MS or LC/MS) are stated as the confirmatory methods for analytical results. Therefore, the "ground truth" is established by these laboratory-based chemical methods, not by human experts interpreting the device's output.
4. Adjudication Method for the Test Set:
- No explicit adjudication method (e.g., 2+1, 3+1) is described. This is expected given that the device is a rapid diagnostic test, and ultimate confirmation is by instrumental chemical analysis (GC/MS or LC/MS) rather than expert consensus on its visual output.
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 study was done. This device is a rapid diagnostic test, not an AI-assisted diagnostic tool. Human "reading" is limited to observing color bands, and the focus is on the device's analytical accuracy compared to reference methods. The document does not mention any AI component or human-in-the-loop performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is inherently a standalone performance study of the immunoassay device itself. The "algorithm" is the biochemical reaction and visual readout. The performance characteristics (sensitivity, precision, cutoff determination, accuracy against reference methods, cross-interference) are all evaluated for the device operating independently of any human interpretation beyond simply observing the presence or absence of a line.
7. The Type of Ground Truth Used:
- The primary ground truth used is analytical confirmation by reference methods, specifically GC/MS or LC/MS. For the precision and cutoff determination studies, this would involve comparing the device's visual results to the known concentrations of spiked drug samples, which are analytically verified. For accuracy, it's a comparison against the results of GC/MS or LC/MS for actual specimens.
8. The Sample Size for the Training Set:
- Not applicable / Not explicitly mentioned. This device is a lateral flow immunoassay, not a machine learning model that requires a "training set." Its operating principles are based on biochemistry and antibody-antigen reactions. The "development" of such a device involves optimizing reagents and manufacturing processes, but not training in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As explained above, there is no "training set" for this type of device.
§ 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).