(51 days)
The Roche ONLINE TDM Valproic Acid assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of valproic acid in human serum or plasma on automated clinical chemistry analyzers. Valproic acid is primarily used in the treatment of petit mal seizures and other generalized and partial complex seizures.
The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with valproic acid and rapidly aggregate in the presence of a valproic acid antibody solution. When a sample containing valproic acid is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to valproic acid concentration is obtained, with the maximum rate of aggregation at the lowest valproic acid concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.
The provided text describes the Roche ONLINE Valproic Acid Assay. Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section. However, the comparison to the predicate device and the discussion of "acceptable results" imply that performance characteristics aligning with or improving upon the predicate device's performance serve as the de facto acceptance criteria.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Roche ONLINE TDM Valproic Acid Assay) |
|---|---|---|
| Method Comparison | R value comparable to predicate (Roche Valproic Acid II or Abbott TDx) | Versus Roche Valproic Acid II: N = 75, Y = 0.969X + 3.003, R = 0.992 |
| Versus Abbott TDx Valproic Acid Assay: N = 77, Y = 1.08X - 0.61, R = 0.972 | ||
| Precision (CV%) | Lower or comparable CV% to predicate device | Level 1: Within Run CV% = 0.8, Total CV% = 2.1 |
| Level 2: Within Run CV% = 0.6, Total CV% = 2.4 | ||
| Level 3: Within Run CV% = 0.6, Total CV% = 1.9 | ||
| Range | Comparable to predicate device | 11.3 to 144.2 µg/mL |
| Other (General) | Acceptable results compared to the predicate device for lower detection limit, specificity, and interfering substances | "All of the evaluation studies gave acceptable results compared to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Method Comparison:
- N = 75 for comparison against Roche Valproic Acid II Assay.
- N = 77 for comparison against Abbott TDx Valproic Acid Assay.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. The study involves comparing a new assay to existing predicate assays, which are themselves considered established methods for measuring valproic acid. Ground truth, in this context, is implicitly defined by the results of the predicate devices.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Given the nature of a quantitative immunoassay comparison, typical adjudication methods used in image interpretation or diagnostic agreement studies (like 2+1 or 3+1) are not directly applicable. The "adjudication" is essentially the statistical comparison between the new assay's results and the predicate assay's results.
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 is not applicable to this device. The Roche ONLINE Valproic Acid Assay is an in vitro diagnostic reagent system for quantitative determination, not an AI-assisted diagnostic tool that aids human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone assay (reagent system run on automated clinical chemistry analyzers); there is no "human-in-the-loop" performance in its direct function. The performance described (precision, method comparison) reflects the algorithm's (assay's) standalone accuracy and reproducibility.
7. The Type of Ground Truth Used:
The ground truth for the performance evaluation was the results obtained from the legally marketed predicate devices, specifically:
- Roche Valproic Acid II Assay (K930734)
- Abbott TDx Valproic Acid Assay
These predicate devices are assumed to provide accurate measurements of valproic acid.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This device is a chemical immunoassay, not a machine learning or AI-based algorithm that requires a "training set" in the computational sense. The "development" of the assay would involve chemical formulation and optimization, not algorithmic training on data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).
§ 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.