(11 days)
The VALP method for the Dimension® clinical chemistry system is a device used to quantitatively measure valproic acid, an anti-convulsant drug, in serum or plasma. VALP test results may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
The VALP method for the Dimension® clinical chemistry system is a particle enhanced turbidimetric inhibition immunoassay which uses a latex particle-valproic acid conjugate and valproic-acid specific monoclonal antibody (Ab). Valproic acid present in the sample competes with the particles for the antibody, thereby decreasing the rate of aggregation. The rate of aggregation is inversely proportional to the concentration of valproic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340nm and 700nm
- Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Correlation Coefficient | 0.995 |
| Slope | 1.10 |
| Intercept | -2.82 µg/mL |
The study demonstrates that the Dade Behring Valproic Acid Method has a very strong correlation (0.995) and a slope close to 1 (1.10) when compared to the Abbott AxSYM® Valproic Acid Assay, indicating substantial equivalence.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 158 clinical patient samples.
- Data Provenance: The document does not specify the country of origin. The data is retrospective, as it involves a "split sample comparison" with existing clinical patient samples.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The ground truth for the test set is established by the results from the predicate device (Abbott AxSYM® Valproic Acid Assay), not by expert review.
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Adjudication Method for the Test Set:
- An adjudication method is not applicable here as the ground truth is established by the predicate device's results, not by expert consensus requiring adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted as this is a comparison for an in-vitro diagnostic device, not an imaging or interpretive device that would typically involve human readers.
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Standalone (Algorithm Only) Performance:
- Yes, a standalone performance was done. The study directly compares the results of the new Dade Behring Valproic Acid Method (an algorithm/assay) against the predicate device. The performance metrics (correlation, slope, intercept) are for the device itself, without human-in-the-loop assistance.
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The Type of Ground Truth Used:
- The ground truth used for the test set was the results obtained from the Abbott AxSYM® Valproic Acid Assay, which served as the predicate device. This is a form of comparative ground truth against a legally marketed and established method.
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Sample Size for the Training Set:
- The document does not explicitly mention a separate "training set" or its sample size. The 158 clinical patient samples are used for the comparison study, which assesses the device's performance against the predicate. In the context of an immunoassay, the "training" (calibration) would typically involve a set of known standards rather than a clinical patient dataset for algorithm development in the way a machine learning model might.
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How the Ground Truth for the Training Set Was Established:
- Given that a specific "training set" of clinical samples with established ground truth a la machine learning is not described, this question is not directly applicable. For new in-vitro diagnostic assays, the device's calibration curve (which is analogous to 'training' the assay to accurately measure concentrations) is typically established using a series of known valproic acid calibrators with assigned concentrations, rather than a dataset of patient samples with independent ground truth established by experts.
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.