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The Dimension Vista™ System Drugs of Abuse Positive Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista™ System.

The Dimension Vista™ System Drugs of Abuse Negative Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista™ System.

The Dimension Vista™ System Drugs of Abuse Positive Control is a liquid, multi-analyte, human urine-based product containing the following constituents at above the cutoff levels of the methods: D-methamphetamine, Secobarbital, Nordiazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, and 11-nor-Δ9-THC-9-COOH. The kit consists of six vials which are ready for use (no preparation is required). The volume per vial is 2.5 mL.

The Dimension Vista™ System Drugs of Abuse Negative Control is a liquid, multi-analyte, human urine-based product containing the following constituents below the cutoff levels of the methods: D-methamphetamine, Secobarbital, Nordiazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, and 11-nor-Δ9-THC-9-COOH. The kit consists of six vials which are ready for use (no preparation is required). The volume per vial is 2.5 mL.

The provided document describes the acceptance criteria and the study conducted for the Dimension Vista™ System Drugs of Abuse Positive Control (UDAT CONT (+) - KC515) and the Dimension Vista™ System Drugs of Abuse Negative Control (UDAT CONT (-) - KC516). These are quality control products, not a diagnostic device for direct patient diagnosis, so the performance criteria and study details are focused on the stability and traceability of the control materials themselves.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a control material, the performance criteria are related to its stability and traceability. The "reported device performance" is essentially that the device met these stability and traceability requirements.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a distinct "test set sample size" in terms of number of unique subjects or samples. Instead, the stability studies involve testing vials of the control material at specific time points. For the punctured vial stability, "multiple tests" are performed, and vials are tested on Day 8, 15, 22, and 32. The number of vials or replicates used for each time point is not specified.
• Data Provenance: The human urine used as the matrix is mentioned, implying human origin. The studies appear to be prospective as they involve real-time stability testing over a period (e.g., 12 months for shelf-life, 7 days for on-board, 31 days for open vial). The location of the studies is implicitly at Dade Behring Inc. in Newark, DE, USA, as they are the applicant and manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in the context of these control materials. "Ground truth" for diagnostic devices typically refers to a definitive diagnosis or condition established by clinical experts or gold standard methods. For control materials, the "ground truth" for the concentration of the analytes is established by Gas Chromatography / Mass Spectrometry (GC/MS) Reference Testing, which is a highly precise analytical technique, not by human expert interpretation in the traditional sense. The expertise lies in operating and interpreting GC/MS results.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" involves analytical measurements against established chemical standards (GC/MS), not subjective human interpretation requiring adjudication.

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 information is not applicable. The device is a quality control material, not an AI-powered diagnostic device. No human reader studies, AI assistance, or MRMC studies were performed or are relevant for this product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a chemical control material. There is no algorithm involved in its primary function, nor is it standalone in the context of AI performance. Its function is to verify the performance of an analytical instrument (Dimension Vista™ System).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the individual analyte concentrations within the control materials is established through Gas Chromatography / Mass Spectrometry (GC/MS) Reference Testing. This is a highly accurate and precise analytical method considered a gold standard for quantifying these substances. The document explicitly states: "The assigned values... are traceable to Gas Chromatography / Mass Spectrometry (GC/MS) Reference Testing."

8. The Sample Size for the Training Set

This information is not applicable. This is a quality control product, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of product.

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