(119 days)
Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of Cannabinoids in human urine. The test is available in a cassette format. The test has a cutoff of 50ng/mL of Cannabinoids. It is intended for prescription use and over the counter use.
The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a conformed analytical result. GCMS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Immunochromatographic assay for Cannabinoids urine test using a lateral flow system for the qualitative detection of Cannabinoids in human urine. Each assay uses a monoclonal antibody-dye congugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse lgG polyclonal antibody in membrane.
Here's an analysis of the provided text, extracting information related to acceptance criteria and the supporting study:
1. A table of acceptance criteria and the reported device performance
Unfortunately, the provided text does not explicitly state specific acceptance criteria in a quantitative manner (e.g., "sensitivity must be >95%"). It generally states that the device has "similar technological characteristics and performance to the predicate and are equivalent." Therefore, the table below reflects what can be inferred or is directly mentioned.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Qualitative detection of Cannabinoids | Qualitatively detects Cannabinoids in human urine |
| Cutoff concentration | 50 ng/mL of Cannabinoids |
| Performance similar to predicate device (K020771) | Device is deemed "equivalent" to the predicate, implying similar performance characteristics. |
| Intended for prescription and OTC use | Indicated for prescription and over-the-counter use |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not contain any information about the sample size used for the test set or the data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The provided text does not contain any information about the number of experts used or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided text does not contain any information about an adjudication method. The device is an immunochromatographic assay, which typically produces a direct "positive" or "negative" result based on chemical reaction, rather than requiring expert adjudication. However, it does state that "A more specific alternative chemical must be used in order to obtain a conformed analytical result. GCMS is the preferred confirmatory method," indicating that initial results are preliminary and further, more definitive testing is recommended for confirmation.
5. 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
The provided text does not contain any information about an MRMC study or AI assistance. The device is a diagnostic test kit, not an AI-powered system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device's inherent performance. The Wondfo Cannabinoids Urine Test is a standalone device in that it provides a direct qualitative result without a "human-in-the-loop" for interpreting the primary reaction. The "standalone performance" is implicitly established by demonstrating its ability to detect cannabinoids at the specified cutoff.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The text mentions that "A more specific alternative chemical must be used in order to obtain a conformed analytical result. GCMS is the preferred confirmatory method." This indicates that Gas Chromatography-Mass Spectrometry (GCMS) is the accepted "ground truth" or gold standard for confirming the presence and concentration of cannabinoids.
8. The sample size for the training set
The provided text does not contain any information about the sample size for a training set. This type of information is usually associated with machine learning or AI-based devices, which this diagnostic test is not.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of this immunochromatographic assay, there is no information provided on how ground truth for a training set was established.
§ 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).