(63 days)
"Rapid Drug Screen" 3-Panel Test for Cocaine, THC and Opiates is a one-step, lateral flow immunoassay for the simultaneous detection in urine of three abused drugs at stated detectable limits. (Each assay occupies a separate channel). It is intended for use in the qualitative detection of Cocaine (Benzoyl ecgonine), 300 ng/ml, THC (Cannabinoids), 50 ng/ml) and Opiates, 300 ng/ml.
"Rapid Drug Screen" is intended for professional use. It is not intended for over the counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. These immuno-assays are simplified qualitative screening methods that provide only a preliminary result for use in the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).
"Rapid Drug Screen" provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
"Rapid Drug Screen" is not intended for use as a Point of Care test.
All of the assays employed in the Rapid Drug Screen panels are based on the same principle of highly specific reaction between antigens and antibodies.
Each assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the "test" area. The formation of a visible line in the test area occurs when the test is below the cut-off for the drug.
When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex.. If sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the test area is indicative of a positive result.
A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present in all reactions.
A negative urine will produce two colored bands, and a positive sample will produce only one band.
Here's an analysis of the provided text regarding the Rapid Drug Screen 3-Panel Test for Cocaine, THC, and Opiates, focusing on acceptance criteria and study information:
Description of Acceptance Criteria and Proving Device Performance
The provided document describes a reproducibility study as the primary method used to demonstrate the device's performance against its claimed detection levels (acceptance criteria). The study aimed to show that the device consistently produces the expected results (positive for drug presence above the cut-off, negative below) when tested multiple times.
1. Table of Acceptance Criteria and Reported Device Performance:
| Analyte | Acceptance Criteria (Detection Level / Cut-off) | Reported Device Performance (Reproducibility Study) |
|---|---|---|
| Benzoyl ecgonine | 300 ng/ml | Confirmed reproducibility using control urines above and below cut-off, and negative controls. |
| THC (Cannabinoids) | 50 ng/ml | Confirmed reproducibility using control urines above and below cut-off, and negative controls. |
| Opiates | 300 ng/ml | Confirmed reproducibility using control urines above and below cut-off, and negative controls. |
Note: The document states "The results confirmed the reproducibility of the Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates." but does not provide specific metrics like sensitivity, specificity, accuracy, or concordance rates from this reproducibility study. It only confirms that the reproducibility was demonstrated.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Each sample was tested four times, twice daily, for five days. The exact number of "control urines" used (i.e., distinct samples at specific concentrations) is not explicitly stated. It's implied there were samples above, below, and negative for each analyte. If we assume at least one unique sample for each category (above, below, negative) for each of the 3 analytes, that would be 9 initial control urine samples, each tested 20 times (4 times/day * 5 days).
- Data Provenance: Not explicitly stated. The document doesn't mention the country of origin of the control urines or if they were clinical samples. It uses the term "control urines," suggesting they were prepared samples with known concentrations. The study is presented as evidence for the premarket notification (510(k)), implying it was conducted as part of the device's development/validation. It would be considered a prospective study in the sense it was designed for this validation purpose.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Experts: Not applicable for establishing the ground truth of the test set itself.
- Qualifications: The ground truth for the test set (control urines) was established through GC/MS (gas chromatography/mass spectrometry), which is a highly accurate analytical method, not by expert interpretation.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The "ground truth" for the control urines was established by GC/MS, an objective chemical analysis. The device's results were then compared against these GC/MS verified concentrations to assess reproducibility. There was no human expert adjudication of the test results themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not done. This device is an in-vitro diagnostic (IVD) immunoassay, not an imaging or diagnostic AI system requiring human interpretation or MRMC studies comparing human readers with and without AI assistance. The performance described relates to the accuracy of the assay itself.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Yes, this is a standalone performance study. The device itself (the immunoassay strip) provides a visual result (presence or absence of a line). The reproducibility study evaluates the device's ability to consistently produce this visual result based on known drug concentrations, without direct human intervention affecting the reading mechanism itself. The output is a clear visual signal (line or no line) that a human then interprets as positive or negative.
7. Type of Ground Truth Used:
- Analytic Ground Truth: The ground truth for the control urine samples was established by Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "All concentrations were verified by GC/MS." GC/MS is considered the gold standard for confirming drug presence and concentration in urine.
8. Sample Size for the Training Set:
- Not applicable. This document describes the validation of a lateral flow immunoassay, which is a pre-designed chemical reaction on a strip. It does not involve machine learning or AI models that require a "training set" in the conventional sense. The "training" of the device is inherent in its chemical design and manufacturing process, optimized to react at specific cut-off levels.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, there is no "training set" in the context of an AI/ML model for this type of device. The development of the device (e.g., antibody selection, conjugate immobilization) would have involved extensive R&D and optimization based on known drug concentrations and chemical principles to achieve the desired cut-offs. The "ground truth" during this development phase would have been lab-prepared samples with known concentrations, verified by analytical methods like GC/MS.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).