(166 days)
The Cannabinoids assay is used for the qualitative analysis of cannabinoids in human urine with a cutoff of 50 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoids use or overdose.
The Cannabinoids assay is calibrated with 11-nor-Δ'-THC-9-COOH and will detect a variety of -Δ'-THC metabolites.
The Cannabinoids assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Cannabinoids assay is an in vitro diagnostic assay for the qualitative analysis of cannabinoids in human urine. The assay is a homogeneous enzyme immunoassay with a 50 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically.
This 510(k) summary describes a new Cannabinoids assay for qualitative analysis of cannabinoids in human urine, using a 50 ng/mL cutoff.
Here's an analysis of the provided information according to your criteria:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative analysis of cannabinoids in human urine with a 50 ng/mL cutoff | The Cannabinoids assay is an in vitro diagnostic assay for the qualitative analysis of cannabinoids in human urine with a 50 ng/mL cutoff. |
| Acceptable concordance with predicate device (Emit® II Cannabinoid assay on SYVA®-30R Analyzer) | 100% agreement between the new Cannabinoids assay and the Emit® II Cannabinoid assay. |
| Acceptable concordance with GC/MS (Gas Chromatography/Mass Spectrometry), generally considered the gold standard for confirmation. | 97% agreement with GC/MS. |
| Precision (within-run and total %CV) for various control levels should be low, indicating reliability and reproducibility. | Total %CV for Verifier I: 1.19% |
| Total %CV for Cutoff Calibrator: 1.13% | |
| Total %CV for Verifier II: 0.63% | |
| Total %CV for -25% Control of Cutoff Calibrator: 2.32% | |
| Total %CV for +25% Control of Cutoff Calibrator: 2.70% | |
| Limit of detection (sensitivity) | 15 ng/mL |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the total number of clinical specimens used for the concordance studies. It only mentions that "The clinical specimens tested ranged from 14.2 to 61.8 ng/mL."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the ground truth was established by laboratory methods (predicate device and GC/MS), not by human expert interpretation of images or other subjective data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Comparisons were made against a predicate device and a confirmatory analytical method (GC/MS).
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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:
- No, an MRMC study was not done. This device is an in vitro diagnostic assay, not an AI-powered diagnostic imaging tool that would typically involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The Cannabinoids assay (the "algorithm" equivalent in this context) was evaluated for its direct comparison against a predicate device and GC/MS without human intervention in the interpretation of the assay's output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used for performance evaluation was:
- Predicate Device: Emit® II Cannabinoid assay on the SYVA®-30R Analyzer.
- Confirmatory Method: Gas Chromatography/Mass Spectrometry (GC/MS), which is cited as the "preferred confirmatory method."
- The primary ground truth used for performance evaluation was:
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The sample size for the training set:
- Not applicable/Not mentioned. Immunoassays like this one do not typically involve "training sets" in the same way machine learning algorithms do. The assay is developed based on chemical principles and reagent optimization rather than data-driven training.
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How the ground truth for the training set was established:
- Not applicable/Not mentioned, as there isn't a "training set" in the context of this immunoassay. The development and optimization of such assays would involve extensive analytical chemistry and biochemical validation rather than establishing ground truth on a data set in the AI sense.
§ 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).