Search Results

The Opiates assay is used for the qualitative analysis of opiates in human urine with a cutoff of 300 ng/mL or 2,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of opiates use or overdose. The Opiates assay is calibrated with morphine and will detect a variety of opiates and their metabolites. The Opiates 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 (GCMS) 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.

Opiates is an in vitro diagnostic assay for the qualitative analysis of opiates in human urine. The assay is a homogeneous 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 dehydrogenase (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.

The provided text describes the acceptance criteria and the study demonstrating the performance of the Opiates assay.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily focuses on demonstrating "substantial equivalence" to a predicate device (Emit II Opiates assay) and acceptable performance against a confirmatory method (GC/MS). The specific numerical acceptance criteria (e.g., minimum concordance percentages) are not explicitly stated as "acceptance criteria" but are implied by the reported results being deemed "acceptable concordance."

2. Sample Size and Data Provenance for Test Set

• Sample Size (AEROSET vs. Emit II): Not explicitly stated, however, the concordance tables provide a combined percentage for both cutoffs.
• Sample Size (AEROSET vs. GC/MS): Not explicitly stated, however, the concordance tables provide a combined percentage for both cutoffs. For the 300 ng/mL cutoff, clinical specimens ranged from 189.0 to 3,063.0 ng/mL, and for the 2,000 ng/mL cutoff, they ranged from 575.0 to 34,980.0 ng/mL.
• Data Provenance: Not explicitly stated (e.g., country of origin). The data appears to be retrospective as it involves comparative performance studies on existing clinical specimens.

3. Number of Experts used to establish ground truth for the test set and their qualifications

This information is not provided in the document. For an immunoassay device, the "ground truth" is typically established by a gold standard laboratory method like GC/MS, rather than human experts.

4. Adjudication method for the test set

This information is not applicable and therefore not provided, as the ground truth was established by laboratory methods (GC/MS and the predicate device), not through human expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging or interpretation-based diagnostic devices where human readers play a significant role. The Opiates assay is an in vitro diagnostic immunoassay, and its performance is assessed against other laboratory methods.

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

Yes, the performance studies described are essentially standalone studies. The Opiates assay is an automated in vitro diagnostic assay, and its performance is evaluated directly through its own analytical output compared to reference methods (Emit II and GC/MS), without direct human-in-the-loop interpretation being part of the primary performance evaluation.

7. The type of ground truth used

The ground truth used for the performance comparison studies was:

• Predicate Device Performance: The Emit II Opiates assay on the SYVA® 30R Analyzer.
• Confirmatory Analytical Method: Gas Chromatography/Mass Spectrometry (GC/MS).

8. The sample size for the training set

This information is not provided in the document. For an in vitro diagnostic assay, a "training set" in the context of machine learning for an algorithm is generally not relevant. The device is likely calibrated using known standards and controls, but a distinct "training set" like in AI/ML model development is not mentioned.

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

This information is not provided. As noted above, the concept of a "training set" and associated ground truth establishment (as typically understood in AI/ML) is not applicable or described for this type of in vitro diagnostic device. The assay uses known calibrators (morphine) and controls, which serve as reference points for its proper function and measurement.

Ask a specific question about this device

Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels G2 and G3 are intended for use as a consistent tool for monitoring assay performance of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.

Not Found

I am sorry, but the provided text only contains a cover letter from the FDA regarding a 510(k) premarket notification for "Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels 1 and 2". It also includes a "Statement of Indications for Use" for "Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels G2 and G3".

This document does not contain any information about:

1. Acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth was established for the training set.

Therefore, I cannot fulfill your request with the input provided.

Ask a specific question about this device

Opiates 2000 Drugs of Abuse Controls are intended for use as a consistent test sample of known concentration for monitoring assay conditions in quantitative and qualitative analyses of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3". It acknowledges that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, the provided text does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. It is a regulatory approval document, not a performance study report.

Therefore, I cannot provide the requested information based on the input text. The elements you asked for (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are typically found in a clinical study report or a technical performance document, which this is not.

Ask a specific question about this device