Search Results

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.

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.

Ask a specific question about this device

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

Study Details

1. 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).

2. 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.

3. 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).

4. 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.

5. 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.

6. 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."

7. 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.

8. 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.

Ask a specific question about this device