(581 days)
The Randox Laboratories Ltd. Ecstasy Assay is an in vitro diagnostic test for the detection of MDMA in human urine with a cut off concentration of 500ng/ml, for use on the Unean of the uneath of Mondal analysers in qualitative or semi-quantititive mode. The assay is calibrated against MDMA. 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 difution 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 chromations chemic ടpectrometry (GCMS) 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.
The Randox Ecstasy Calibrator Set consists of liquid calibrators containing MDMD. There are 5 levels of calibrator. They have been developed for use in the calibration of Ecstasy assays on the J X day to na" and Amela" analysers. This in vitro diagnostic device in the daily as a line a for prescription use only.
The Randox Ecstasy Controls, level 1 and 2 are liquid controls containing MDMA. There are 2 levels of controls. They have been developed for use in the quality control of the Ecstasy assay on the a X day to na" and annual analysers. This in quality control of the ebstay of the only.
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The provided document is a 510(k) clearance letter for the Randox Ecstasy (MDMA) Assay, Calibrator Set, and Controls. It describes the device's intended use and the regulatory approval process. However, it does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.
The document is a regulatory communication, not a performance study report. It confirms that the device is substantially equivalent to legally marketed predicate devices, meaning that its performance is considered comparable to existing, approved devices. The specific performance data and the studies demonstrating that performance are typically found in the submission documents to the FDA, which are not included here.
Therefore,Based on the provided document, I cannot fulfill your request for the following information:
- A table of acceptance criteria and the reported device performance: This detailed performance data is not present in the 510(k) clearance letter.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
- Adjudication method for the test set: Not available in this document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an in vitro diagnostic assay (a laboratory test) for MDMA in urine, not an AI-powered image analysis tool for human readers. Therefore, an MRMC study is not relevant here.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: As an in vitro diagnostic assay, its performance is inherently "standalone" in the sense that it provides a direct analytical result. However, the specific details of performance studies are not in this document.
- The type of ground truth used: While the indication for use mentions Gas Chromatography-Mass Spectrometry (GCMS) as the preferred confirmatory method, the document does not explicitly state that GCMS was used as the ground truth for the equivalence study.
- The sample size for the training set: Not available in this document. This is an assay, not a machine learning algorithm with a "training set" in the typical sense.
- How the ground truth for the training set was established: Not applicable for this type of device in the context of a "training set."
What the document does provide:
- Device Name: Randox Ecstasy (MDMA) Assay, Calibrator Set, and Controls.
- Indication for Use: In vitro diagnostic test for the detection of MDMA in human urine with a cutoff concentration of 500ng/ml. For use on specific analysers (though the analyser names are obscured as "Unean of the uneath of Mondal" and "J X day to na" and "Amela"). Primarily qualitative or semi-quantitative. Semi-quantitative mode is for determining dilution for confirmatory methods (like GCMS) or for quality control.
- Confirmatory Method: States that a more specific alternative chemical method must be used for confirmation, with GCMS being the preferred method.
- Prescription Use: The device is for prescription use only.
- Ground Truth (implied/recommended confirmatory): GCMS is mentioned as the preferred confirmatory method.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).