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The Randox Laboratorles Ltd. barbiturates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on the Rx Imola and Rx Daytona. The cutoff for secobarbital is 200 ng/mL. This in vitro diagnostic device Is intended for prescription use only.

The semi-quantitative mode is for purpose of

• (1) enabling laboratories to determine an appropriate dilution of the specimen for
• confirmation by a confirmatory method such as GCMS.
• Or
• .. .. . ... . . . . . . (2) permilting 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 Multidrug Calibrator Set consists of liquid calibrators containing Secobarbital, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Barbiturates, Benzodiazepines and Methadone assays for use on the JSC and analysers, which includes the a y to na" and the moss™. This in vitro diagnostic device is intended for prescription use only.

The Randox Multidrug Controls level 1 and 2 are liquid controls containing Secobarbital, Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Barbiturates, Benzodiazepines and Methadone assays for use on the I Kommanalysers, which includes the X day to na™ and the Anmone™. This in vitro diagnostic device is intended for prescription use only.

Not Found

The provided text is a 510(k) premarket notification letter for the Randox Barbiturates Assay, Randox Multidrug Calibrator Set, and Randox Multidrug Controls. It mentions the device's indications for use but does not contain information about acceptance criteria, analytical studies, or clinical studies that prove the device meets specific performance criteria.

Therefore, I cannot fully complete the requested table and answer all the questions based on the provided document. The document is primarily an FDA clearance letter, not a study report.

However, I can extract what little information is available regarding the device itself.

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the given document. The document is a clearance letter, not a study report detailing performance data against acceptance criteria.

2. Sample size used for the test set and the data provenance:

This information is not provided in the given document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the given document.

4. Adjudication method for the test set:

This information is not provided in the given document.

5. 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 is an in vitro diagnostic (IVD) assay for detecting barbiturates in urine. It is not an AI-driven device or an imaging device that would involve human readers or MRMC studies. Therefore, this question is not applicable to the device described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is an IVD assay, not an algorithm. The concept of "standalone performance" in the context of an algorithm is not applicable to this device.

7. The type of ground truth used:

This information is not explicitly provided in the given document. However, the "Indication for Use" section states: "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." This strongly implies that GC/MS would be used as the ground truth for confirming preliminary analytical results of the assay.

8. The sample size for the training set:

This information is not provided in the given document.

9. How the ground truth for the training set was established:

This information is not provided in the given document. However, similar to item 7, it's highly probable that GC/MS would be the method for establishing ground truth for any calibration or validation samples.

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