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The Cocaine assay is used for the qualitative analysis of benzolecgonine (cocainc metabolite) in human urine with a cutoff of 300 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

The Cocainc assay is calibrated with Benzoylcegonine and will detect cocaine and the major metabolites.

The Cocaine assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Cocaine is an in vitro diagnostic assay for the qualitative analysis of benzoylecgonine (cocaine metabolite) in human urine. The assay is a homogencous enzyme immunoassay with a 300 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenasc (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity.

Here's a breakdown of the acceptance criteria and study information for the Abbott Laboratories Cocaine assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "acceptable correlation" as the general criteria for comparison studies. For precision, the low coefficient of variation (%CV) values implicitly define the acceptable range.

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

• Sample Size: The document mentions that the clinical specimens tested for the GC/MS comparison ranged from 56.8 to 70,040.0 ng/mL, implying a range of cocaine metabolite concentrations. However, the number of clinical specimens used as a test set for the comparison studies (both with the predicate and GC/MS) is not explicitly stated.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The term "clinical specimens tested" suggests real-world samples, but further details are not provided.

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

• Number of Experts: Not applicable, as this device uses laboratory assays as its comparative standards, not human expert interpretation of images or clinical data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The comparisons are based on analytical results from other laboratory assays (predicate device and GC/MS), which have predefined analytical criteria for results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic assay, meaning its performance is evaluated against other laboratory tests, not by human readers interpreting results.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Yes, the performance characteristics (precision, cutoff, limit of detection) of the Cocaine assay were evaluated in a standalone manner. The comparison studies (with the predicate device and GC/MS) also represent the standalone performance of the new device against established methods.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for evaluating the Cocaine assay's performance was established using two methods:
  • Comparison to a legally marketed predicate device: The Emit® II Cocaine assay on the SYVA® 30R Analyzer (K902579).
  • Comparison to a confirmatory chemical method: Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is explicitly stated as the "preferred confirmatory method" and serves as a higher-level analytical ground truth for drug testing.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated. The document describes performance and comparison studies but does not provide details about a specific "training set" in the context of machine learning, as this device is an immunoassay, not an AI/ML-based diagnostic. It's likely that internal development and validation samples were used during the assay's creation and optimization, but these are not specified as a "training set" in the provided text.

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

• Ground Truth for Training Set: Not applicable in the context of machine learning. For an immunoassay, the "ground truth" for development would involve known concentrations of the analyte (cocaine metabolite) in control samples, and the assay is optimized to accurately detect these concentrations around the specified cutoff. This is established through standard laboratory practices for assay development and analytical validation using certified reference materials and known-concentration samples.

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