Search Results

The evidence®Cannabinoids test has been designed for use only on the evidence® analyser to detect cannabinoids in urine, using a cut-off of 50ng/ml. Qualitative results obtained can be utilised in the diagnosis of cannabinoid use or abuse.

This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS.

The Cannabinoids Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The evidence® Drugs of Abuse Calibrators.

The evidence®Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and 11-nor-D9-THC-9 carboxylic acid.

There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system.

The evidence®Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Not Found

This appears to be a 510(k) premarket notification letter for the Randox Laboratories, Ltd. "evidence® Cannabinoids Assay and evidence® Drugs of Abuse Calibrators." This type of document from the FDA primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than a detailed study report demonstrating performance against specific acceptance criteria in the manner of a clinical trial for a novel AI/software medical device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not typically found in this kind of 510(k) letter. This letter is a regulatory approval document, not a scientific publication of a performance study.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that would accompany a premarket submission (PMA or a more detailed 510(k) for a device with novel characteristics).

Based on the provided document, I can infer the following limited information, but I cannot provide the detailed breakdown requested:

• Device Type: This is a diagnostic test kit (Cannabinoids Assay) and associated calibrators. It is not an AI/software medical device that performs image analysis or requires expert interpretation in the way your prompt implies.
• Performance (Inferential): The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This means its performance is considered comparable to existing devices already on the market. However, the specific performance metrics and acceptance criteria for this device are not detailed here. The indication for use mentions a "cut-off of 50ng/ml," which is a performance characteristic, but not a full set of acceptance criteria.
• Ground Truth (Inferential): The document states, "This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS." This implies that Gas Chromatography-Mass Spectrometry (GC/MS) is considered the "gold standard" or ground truth for confirming cannabinoid use, but this relates to post-assay confirmation, not how the ground truth for validating the assay itself was established during its development.
• No Information Available: All other specific details requested (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, training set ground truth establishment) are not present in this FDA 510(k) letter.

In summary, I cannot fill out the requested table or provide the detailed study information because the provided document is a regulatory approval letter, not a performance study report for the device.

Ask a specific question about this device