(478 days)
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.
Not Found
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:
- 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.
- 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.
- 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.
- Adjudication method: Not mentioned.
- 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.
- 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.
- 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.
- 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.
- 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.
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).