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The cassette COBAS Integra Serum Barbiturates contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum, heparinized plasma or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose.

The COBAS INTEGRA Serum Barbiturates assay is an in vitro diagnostic reagent for use on the COBAS INTEGRA systems for the detection of barbiturates and their metabolites in plasma, serum or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose. The COBAS INTEGRA Serum Barbiturates assay is based on fluorescence polarization (FP) methodology. Fluorescence polarization measures the change in angle of polarized light emitted by a fluorescent molecule. This change in polarization is dependent on molecule rotation, which is dependent on molecule size. FP utilizes a homogeneous competitive binding immunoassay with particle-bound fluorescein-labeled drug derivative to detect barbiturates and their metabolites in unknown samples. In the absence of sample drug, free antibody (R1) binds to fluorescein-labeled drug derivative (R3), causing the fluorescein-labeled drug derivative to rotate slowly. The large complex rotates more slowly than the free fluoresceinlabeled drug derivative in solution, thereby causing the light emitted to remain highly polarized. When a urine sample contains the drug in question, this drug competes with the fluorescein-labeled drug derivative for antibody. The small fluoresceinlabeled drug derivative molecules will rotate rapidly in solution and the emitted light will be depolarized. The large molecules (antibody bound to fluorescein labeled drug) will rotate slowly and the light emitted will remain highly polarized. Large molecules = slow rotation = polarized light retained = high polarization Small molecules = rapid rotation = depolarized light = low polarization Unknown sample drug content is determined relative to the value obtained from samples of known drug content, which have been used to establish a standard curve. The presence of drug decreases polarization in proportion to the concentration of drug in the sample.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets these criteria. The document is primarily a 510(k) summary for the Roche COBAS INTEGRA Serum Barbiturates assay, focusing on its substantial equivalence to a predicate device and its intended use.

However, based on the information provided, here's what can be inferred and what is missing:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria in a table format or present specific performance metrics from a study to demonstrate compliance. It generally states that "The assay performance characteristics for urine and serum samples are extremely similar" to the predicate device.

Missing Information:

• Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy against a gold standard, precision, linearity ranges, cutoff values).
• Detailed performance data (e.g., test results, statistical analysis) that would show the device meets these unstated criteria.

Study Details

Given the nature of a 510(k) summary for an in vitro diagnostic device, the "study" demonstrating performance would typically involve analytical and possibly some clinical validation against a known ground truth. However, specific details of such studies are largely absent.

1. A table of acceptance criteria and the reported device performance:

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

• Sample Size for Test Set: Not specified.
• Data Provenance (e.g., country of origin, retrospective or prospective): Not specified.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. (For an IVD like this, ground truth is typically established by reference methods or clinical diagnosis, not necessarily by "experts" in the sense of image interpretation).

4. Adjudication method for the test set:

• Adjudication Method: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC study is not typically applicable or mentioned for this type of in vitro diagnostic assay. MRMC studies are usually relevant for imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated.

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

• Yes, for an in vitro diagnostic device, the performance characteristics described are inherently "standalone," meaning they represent the algorithm (assay system) itself determining the presence or concentration of barbiturates in a sample. The device operates without human-in-the-loop decision making for the analytical result.

7. The type of ground truth used:

• Type of Ground Truth: Not explicitly stated. For in vitro diagnostic assays, ground truth is typically established against:
  • Reference Methods: Such as Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) for drug detection.
  • Clinically Confirmed Samples: Samples from patients with known barbiturate use or overdose, or samples spiked with known concentrations of barbiturates.
    While not explicitly mentioned, it can be inferred that a combination of these methods would have been used for an IVD.

8. The sample size for the training set:

• Sample Size for Training Set: Not specified. For this type of homogeneous fluorescence immunoassay, "training" is less about machine learning algorithms and more about establishing standard curves and calibrating the instrument. The "training set" would correspond to the samples used to establish these curves and confirm assay parameters.

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

• Ground Truth for Training Set: Not specified. Similar to the test set, ground truth for calibrator and control samples would be established using highly accurate reference methods or by gravimetric preparation of known concentrations of barbiturates. This ensures the standard curve accurately reflects drug concentrations.

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