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The Randox Laboratories Ltd. Cannabinoid Assay is an in vitro diagnostic test for the detection of 11-nor-d -THC-9-COOH (THC) in human urine on the Rx imola and Rx Daytona. The cut off for 11-nor-A-THC-9-COOH (THC) is 50ng/ml, This in vitro diagnostic device is intended for prescription use only.

The semi-quantitative mode is for purposes of

• (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS
  or

• (2) permitting laboratories to establish quality control procedures.

This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) 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.

The Randox Cannabinoid Calibrator Set consists of liquid calibrators containing 11-nor-Δ2-THC-9-COOH (THC). There are 5 levels of calibrator. They have been developed for use in the calibration of THC assays on the X day to na™ and Anmond analysers. This in vitro diagnostic device is intended for prescription use only.

The Randox Cannabinoid Controls, level 1 and 2 are liquid controls containing 11-nor-A -THC-9-COOH (THC). There are 2 levels of controis. They have been developed for use in the quality control of the THC assay on the X day to na™ and Amond analysers. This in vitro diagnostic device is intended for prescription use only.

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Here's an analysis of the provided text, focusing on acceptance criteria and study information:

Acceptance Criteria and Device Performance for Randox Cannabinoids Assay

Based on the provided document, the Randox Cannabinoids Assay is an in vitro diagnostic test for the detection of 11-nor-d-THC-9-COOH (THC) in human urine. The key performance aspect described is its ability to detect THC relative to a specified cutoff.

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states one critical acceptance criterion, which is a cutoff level. While it doesn't provide a comprehensive table of all acceptance criteria (e.g., sensitivity, specificity, accuracy against a reference method, precision statistics), it does state the primary analytical threshold.

Note: The document describes the intended use and the cutoff for the assay. It does not provide detailed performance metrics (like sensitivity, specificity, or accuracy) derived from a specific study within these pages. Therefore, a comprehensive "reported device performance" against a full suite of acceptance criteria cannot be extracted solely from this text. The statement "This assay provides only a preliminary analytical result" implies that further confirmatory testing (like GC/MS) is required, highlighting its role as a screening test.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This information would typically be found in a detailed study report that supports the 510(k) submission, which is not present here.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The provided document does not specify the number of experts used to establish ground truth or their qualifications. Given that the device is a chemical assay for a biomarker, the ground truth would likely be established through a definitive analytical method rather than subjective expert interpretation (like in imaging).

4. Adjudication Method for the Test Set

The provided document does not specify any adjudication method for a test set. This is consistent with a chemical assay where results are quantifiable and less subject to subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or discussed in the provided document. This type of study is typically relevant for interpretative devices (e.g., medical imaging AI) where multiple human readers are involved. The Randox Cannabinoids Assay is an in vitro diagnostic test that provides a quantitative or semi-quantitative result; therefore, an MRMC study is not applicable.

6. Standalone Performance Study

The document implies that standalone performance was evaluated in terms of establishing the 50 ng/ml cutoff. However, the details of the study (e.g., sensitivity, specificity, accuracy against a reference method) that demonstrate this standalone performance are not provided in this extract. The device's nature as an "in vitro diagnostic device" performing a "test for the detection" inherently means its performance without human intervention (beyond operating the instrument) is what is being assessed.

7. Type of Ground Truth Used

The type of ground truth used for this device would almost certainly be a more specific and definitive analytical method, such as Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method," indicating it serves as the gold standard for confirmation. While not explicitly stated as the ground truth for the preliminary assay's development, it is the implied standard against which the assay's performance would be compared for validation.

8. Sample Size for the Training Set

The provided document does not specify the sample size for any training set. This information would be found in a detailed study report. For an in vitro diagnostic assay, the "training" aspect might relate to the development and optimization of the assay reagents and conditions, rather than a machine learning training set in the typical AI sense.

9. How the Ground Truth for the Training Set Was Established

The provided document does not specify how the ground truth for any training set was established. Similar to point 8, if a "training set" were relevant, the ground truth would likely be established using a definitive analytical method like GC/MS.

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