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The Randox Laboratories Ltd. Methadone Assay Is an in vitro diagnostic test for the qualitative and semiquantitative detection of Methadone in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for methadone. The Randox Methadone Assay has been developed for use on the seems analysers, which includes the day to name and the seemer ". 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 chromatographimass 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 proliminary result is positive.

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The provided document is a 510(k) premarket notification letter from the FDA to Randox Laboratories, Ltd. for a Methadone Assay, Multidrug Calibrator Set, and Multidrug Controls. Unfortunately, the document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study that proves the device meets them.

The document primarily focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• The device's regulation number, product code, and regulatory class.
• General controls provisions of the Act that apply to the device.
• Contact information for various FDA offices.
• The Indications for Use statement for the Methadone Assay, Multidrug Calibrator Set, and Multidrug Controls.

Missing Information

The document does not provide the following crucial details needed to address the request:

1. A table of acceptance criteria and the reported device performance: This would typically include metrics like sensitivity, specificity, accuracy, precision, limit of detection, etc., along with the predefined targets for these metrics.
2. Sample size used for the test set and the data provenance: There is no mention of the clinical or analytical study design, the number of samples, or their origin.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is integral to understanding the validation process.
4. Adjudication method: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is more common for imaging diagnostics involving human interpretation, which is not the case for an in vitro diagnostic assay like this one. Therefore, it is highly unlikely such a study was performed or would be relevant.
6. Standalone performance (algorithm only without human-in-the-loop performance): While the device is an IVD assay and its performance would inherently be "standalone" in terms of measurement, the document does not present the data.
7. Type of ground truth used: For an IVD assay, ground truth is usually established by a reference method (e.g., GC/MS), but this is not explicitly detailed with performance data. The "Indications for Use" does state that GC/MS is the preferred confirmatory method, implying it would be used for confirmation if a preliminary positive result is obtained.
8. Sample size for the training set: Not applicable for this type of 510(k) submission unless an AI/ML component was specifically part of the device's analytical engine, which is not indicated. These are typically validated through analytical and clinical performance studies, not AI-style training and test sets in the same way.
9. How the ground truth for the training set was established: See point 8.

In summary, this document only confirms the FDA's clearance of the device based on substantial equivalence and specifies its intended use and regulatory classification. It does not contain the detailed validation study results or acceptance criteria. To obtain this information, one would typically need to refer to the full 510(k) submission document or the device's labeling (Instructions for Use or Package Insert) which would contain the performance data.

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1 Methadone Assay: The 1 methadone assay has been designed for use only on the 1 analyser for qualitative detection of methadone, a narcotic pain-relieving drug, in urine using a cutoff concentration of 300 ng/mL. Qualitative results obtained can be utilised in the diagnosis and treatment of methadone use or overdose. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The 1 Methadone Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Evidence Drugs of Abuse Calibrators: The Evidence Drugs of Abuse Calibrators are liquid Calibrators containing Methadone. There are 9 levels of calibrator. They have been developed for use in calibration of the 1 system. The Evidence Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "1 Methadone Assay and Evidence Drugs of Abuse Calibrators." This document determines substantial equivalence to a predicate device and outlines the intended use. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone performance study for the algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in the 510(k) submission document itself, particularly in the sections detailing analytical and clinical performance studies, which are not part of this clearance letter.

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