(117 days)
The Drug Detection Devices Marijuana Test is a rapid, qualitative, competitive binding immunoassay for the determination of Cannabinoids and its metabolites in urine. The test provides only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. This test is not intended to be used in monitoring cannabinoid levels.
The sponsor Drug Detection Devices Ltd. (6620 Meadowridge Court, Suite A-7, Alpharetta, GA 30005) has had developed and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Marijuana and its metabolites in a screening format. The Trade names of the device are SCREENERS Marijuana Test and DrugScreen Dip Marijuana Test, having a designated common name of Cannabinoid Test System and a classification as a class II device per 21 CFR 862.3870. This device is intended for medical/forensic screening of urine. Drug Detection Devices Marijuana 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 up 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 rose-pink color band when the detection level of 50 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.
Here's an analysis of the provided text, focusing on the acceptance criteria and the supporting study for the DrugScreen Dip Marijuana Test SCREENERS Marijuana Test:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance (In-house) | Reported Device Performance (Clinical Trial) |
|---|---|---|
| Sensitivity | 0.9801 | 0.993 |
| Specificity | 0.9636 | 1.00 |
| Accuracy | 97.32% | 99.67% |
Note: The document does not explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >0.95"). Instead, it presents the results of the studies and implies that these results were deemed acceptable.
2. Sample Size Used for the Test Set and Data Provenance
- In-house testing: 261 individual urine samples.
- Clinical trial: The sample size for the broader clinical trial is not explicitly stated beyond being referred to as "a broader clinical trial."
- Data Provenance: The document does not specify the country of origin. The in-house testing was likely conducted by the sponsor (Drug Detection Devices Ltd.), and the clinical trial was conducted in a "NIDA certified laboratory." Both appear to be prospective in nature, as the device was developed and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth for both the in-house testing and the clinical trial was established using Syva Emit and GC/MS (Gas Chromatography/Mass Spectrometry) for the in-house study, and GC/MS as the "gold standard" for the clinical trial.
- The document does not mention the use of human experts to establish ground truth. The ground truth was based on established laboratory analytical methods.
4. Adjudication Method for the Test Set
- Not applicable. Since the ground truth was established by laboratory analytical methods (Syva Emit and GC/MS), there was no need for human expert adjudication. The comparison was direct between the device's result and the reference method's result.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The device is a diagnostic test where the output is directly compared against established analytical methods, not interpreted by multiple human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The entire evaluation described is for the device's performance (SCREENERS Marijuana Test / DrugScreen Dip Marijuana Test) without human interpretation as part of the primary test result. The device itself produces the qualitative result (presence or absence of Marijuana metabolites). The indication for use states that results "should be confirmed by other methods" and "Clinical considerations and professional judgment should be applied," but this refers to the interpretation of the preliminary result, not the device's inherent performance.
7. The Type of Ground Truth Used
- Laboratory Analytical Methods:
- In-house testing: Syva Emit and GC/MS
- Clinical trial: GC/MS (referred to as the "gold standard")
8. The Sample Size for the Training Set
- The document does not explicitly state the sample size for a training set. The testing described appears to be a validation of the final product. It's likely that internal development and optimization would have involved data, but it's not specified as a distinct "training set" in this summary.
9. How the Ground Truth for the Training Set was Established
- As a training set is not explicitly mentioned, the method for establishing its ground truth is not provided. It can be inferred that any data used during development and optimization would also have relied on reference laboratory methods similar to those used for validation.
§ 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).