(169 days)
for the qualitative testing of urine for the presence of Cannabinoids and their metabolites in a screening format. This device is intended for medical/forensic screening of urine.
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 magenta color band when the drug is above the detection level of 50 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity (compared to Emit) | 99.3% |
| Specificity (compared to Emit) | 1.00 (100%) |
| Concordance | 99.67% |
| Detection Level | 50 ng/ml for Cannabinoids |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 261 individual urine samples.
- Data Provenance: Not explicitly stated, but the mention of "in-house testing" and an "independent Clinical Trial" suggests a mix, likely domestic to the US where the company and consultants are located. It is retrospective in the sense that the samples were tested against existing reference methods.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: The ground truth was established by reference methods (Syva Emit and GC/MS), not by human experts interpreting results. The expertise lies within the accuracy and validation of these established laboratory methods.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The comparison was made against established laboratory reference methods (Syva Emit and GC/MS), which serve as the "ground truth." There was no human adjudication process described for the test set results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This study is for a diagnostic device (Cannabinoid Test System) that provides a qualitative result, not for an AI assistance system for human readers.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: Yes. The performance metrics (sensitivity, specificity, concordance) are reported for the device itself when compared against reference methods. There is no human-in-the-loop component described for this specific performance evaluation.
7. Type of Ground Truth Used
- Type of Ground Truth: Established laboratory reference methods:
- Syva Emit: A homogenous enzyme immunoassay system commonly used for screening drugs of abuse.
- GC/MS (Gas Chromatography-Mass Spectrometry): A highly accurate and definitive method for identifying and quantifying substances in a sample, often considered the "gold standard" for drug testing.
8. Sample Size for the Training Set
- Sample Size: Not explicitly stated. The provided text describes the evaluation of the final product using 261 samples. It does not provide details about a separate training set, implying that the device's development and calibration (analogous to training) were done prior to this reported performance study, and the 261 samples represent a test set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established for Training: Not explicitly stated. Given that this is a chemical diagnostic device and not a machine learning algorithm in the modern sense, the "training" would involve:
- Optimizing reagent concentrations.
- Calibrating the detection threshold (in this case, 50 ng/ml).
- Ensuring proper design and manufacturing to achieve the desired performance characteristics.
This process would have involved internal validation studies during development, likely using known positive and negative samples, but specifics are not provided in this summary.
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Summary of Safety and Effectiveness
FEB 28 1997
Karas Su
The sponsor Syntron Bioresearch Inc. (277 Loker Ave. West, Carlsbad, Ca., 92008) has developed, manufactured and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Cannabinoids and their metabolites in a screening format.
The Trade name of the device is QuikStrip™ One Step Marijuana (THC) 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.
Syntron's QuikStrip™ One Step Marijuana (THC) 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 magenta color band when the drug is above the detection level of 50 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
The sponsor subjected the final product to both in-house testing of 261 individual urine samples using both the Syva Emit and GC/MS against the new product and an independent Clinical Trial. The calculated relative sensitivity compared to Emit was 99.3% and the calculated relative specificity against Emit was found to be 1.00 with concordance of 99.67%. Statistical comparisons of all possible combinations of reference methods to the experimental new device failed to identify any significant difference between the reference method and the new Syntron method.
Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President of Drial Consultants Inc. at 805-522-6223 or by fax at 805-522-1526 who is Syntron's designated regulatory consultant. Specific Corporate information may be obtained from Dr. James Lee, President of Syntron Bioresearch at the address given in the first paragraph.
§ 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).