(68 days)
dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest tetrahydrocannabinol Test Kit are for professional and laboratory use only.
dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml.
The provided text is a 510(k) clearance letter from the FDA for a device called "dBest Tetrahydrocannabinol Test Kits." It determines the device's substantial equivalence to a predicate device. However, this document does not contain the detailed study results, acceptance criteria, or performance data that would typically be found in a device's submission or clinical study report.
Therefore, I cannot fully complete the requested table and information based solely on the provided text. The document is an FDA clearance letter, not a detailed technical report of a study.
Here's what I can extract and what I cannot:
What can be extracted:
- Device Name: dBest Tetrahydrocannabinol Test Kits
- Intended Use Statement: "dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest tetrahydrocannabinol Test Kit are for professional and laboratory use only."
- Regulatory information: This is a Class II device, Cleared via 510(k) K983188.
What cannot be extracted (as it's not present in the provided document):
- Specific acceptance criteria (e.g., sensitivity, specificity thresholds).
- Reported device performance values against acceptance criteria.
- Details of the study that proves the device met acceptance criteria (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).
Table of Acceptance Criteria and Reported Device Performance (Based on what should be there, but is not in the provided text):
| Acceptance Criterion (Hypothetical, based on typical IVD performance) | Reported Device Performance (Not in document) |
|---|---|
| Sensitivity at 50 ng/mL cutoff (e.g., ≥95%) | Not reported in provided text |
| Specificity for THC metabolites (e.g., ≥95%) | Not reported in provided text |
| Interference from common substances (e.g., no cross-reactivity) | Not reported in provided text |
| Precision/Reproducibility (e.g., consistent results) | Not reported in provided text |
Detailed Study Information (Not available in the provided document):
- Sample size used for the test set and the data provenance: Not mentioned in the provided text.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in the provided text.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned in the provided text.
- 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: Not applicable. This is an immunochromatographic assay for THC, not an AI-assisted diagnostic imaging task that would typically involve human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a "one step immunochromatographic assay," implying it is a standalone test kit, not an algorithm. Performance would be assessed directly from the test result.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned in the provided text. For a drug test, the ground truth would typically be established by a more definitive laboratory method (e.g., GC/MS or LC/MS) on the same urine samples.
- The sample size for the training set: Not applicable based on the nature of this device as a traditional immunochromatographic assay. There isn't an "algorithm" being trained in the typical AI sense.
- How the ground truth for the training set was established: Not applicable for the same reason as point 7.
In summary, the provided document is a regulatory clearance letter and does not contain the detailed technical or clinical study data requested. To answer these questions, one would need access to the full 510(k) submission document or a summary of the performance data that supported this clearance.
§ 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).