(189 days)
This device is intended for medical/forensic screening of urine.
The Trade name of the device is QuikPac II™ 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. Syntron's QuikPac II™ 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the QuikPac II™ One Step Marijuana (THC) Test:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| High Relative Sensitivity (compared to Syva Emit) | 99.3% |
| High Relative Specificity (compared to Syva Emit) | 1.00 (100%) |
| High Concordance (agreement with Syva Emit) | 99.67% |
| No significant difference compared to reference methods (Syva Emit and GC/MS) | "failed to identify any significant difference" |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for sensitivity, specificity, or concordance. However, the reported performance metrics (99.3% sensitivity, 100% specificity, 99.67% concordance, and no significant difference from reference methods) are presented as favorable outcomes, implying these levels met the sponsor's internal or regulatory expectations for acceptance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 261 individual urine samples.
- Data Provenance: The text states "in house testing," which typically implies the data was collected at or under the direct supervision of the sponsor (Syntron Bioresearch Inc.). It also mentions "an independent Clinical Trial," but the 261 samples seem to be from the "in house testing." The country of origin is not explicitly stated, but the sponsor is based in Carlsbad, CA, suggesting the US. The study appears to be retrospective as it uses "individual urine samples" that would have already been collected and tested by the reference methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
The ground truth was established by comparison to reference methods (Syva Emit and GC/MS), not by human expert interpretation of the device results themselves. The "experts" in this context would be the technicians operating and interpreting the reference methods, but their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Not applicable in the sense of multiple human readers adjudicating results. The comparison was directly against established laboratory reference methods (Syva Emit and GC/MS). There's no mention of an adjudication process for discrepancies between the device and these reference methods, other than statistical comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the device against established laboratory methods, not on how the device assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone study was done. The described testing of the QuikPac II™ device against Syva Emit and GC/MS is a direct measure of the device's diagnostic performance without human interpretation influencing the reported sensitivity, specificity, or concordance. The device itself provides a qualitative result (presence or absence of cannabinoids).
7. The Type of Ground Truth Used
- The ground truth was established using reference laboratory methods:
- Syva Emit (likely an enzyme immunoassay)
- GC/MS (Gas Chromatography/Mass Spectrometry), which is often considered a gold standard for drug confirmation testing due to its high specificity and ability to identify specific compounds.
8. The Sample Size for the Training Set
- The document does not specify a separate training set or its sample size. The 261 samples are described as "in house testing" of the "final product," suggesting these were used for validation, not necessarily for training a machine learning model. Given this is a chemical assay, not an AI/ML device, a "training set" in the context of model development is unlikely to apply in the traditional sense. The device's design and parameters would have been developed through R&D, but not a distinct "training set" like for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as a distinct training set with its own ground truth establishment is not mentioned or implied for this type of chemical diagnostic device. The development process would involve chemical formulation and optimization, guided by principles of antigen-antibody reactions, rather than data-driven machine learning training.
§ 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).