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The Randox Laboratories Ltd. Methadone Metabolite Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of 2-ethylidene-1,5-diphenylpyrrolidine (EDDP) in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for EDDP. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of EDDP use or overdose. The Randox Metabolite Assay has been developed for use on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. 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 EDDP Calibrator Set consists of liquid calibrators containing EDDP. There are 5 levels of calibrator. They have been developed for use in the calibration of EDDP assays on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.

The Randox EDDP Controls, level 1 and 2 are liquid controls containing EDDP. There are 2 levels of controls. They have been developed for use in the quality control of the EDDP assay on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.

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The provided text is a 510(k) summary for the Randox Methadone Metabolite (EDDP) Assay, EDDP Calibrator Set, and EDDP Controls Level 1 & 2. It outlines the regulatory clearance of the device but does not contain a detailed description of the acceptance criteria nor a comprehensive study report with the specific information requested in your prompt.

Specifically, the text is a letter from the FDA informing Randox Laboratories, Ltd. that their device is substantially equivalent to legally marketed predicate devices. It states the indications for use, regulatory classification, and general controls provisions.

Therefore, I cannot provide the requested information based solely on the provided input. The document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• Number/qualifications of experts, adjudication methods for ground truth, or details about the ground truth itself (pathology, outcomes data, etc.).
• Information on MRMC studies or standalone algorithm performance.

To obtain the information you're looking for, you would typically need to review the full 510(k) submission document or a more detailed study report.

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