(175 days)
The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.
The ARCHITECT iValproic Acid Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of valproic acid in human serum or plasma.
The ARCHITECT iValproic Acid assay is a one-step STAT immunoassay for the quantitative measurement of valproic acid in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antivalproic acid coated paramagnetic microparticles, and valproic acid acridiniumlabeled conjugate are combined to create a reaction mixture. The anti-valproic acid coated microparticles bind to valproic acid present in the sample and to the valoroic acid acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is mcasured as relative light units (RLUs). An indirect relationship exists between the amount of valproic acid in the sample and the RLUs detected by the ARCHITECT i System optics.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the ARCHITECT iValproic Acid assay:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalency to AxSYM Valproic Acid assay in terms of precision. | Demonstrated through non-clinical performance data (specific value not given, but stated as meeting equivalency). |
| Substantial equivalency to AxSYM Valproic Acid assay in terms of linearity. | Demonstrated through non-clinical performance data (specific value not given, but stated as meeting equivalency). |
| Substantial equivalency to AxSYM Valproic Acid assay in terms of interferences. | Demonstrated through non-clinical performance data (specific value not given, but stated as meeting equivalency). |
| Correlation coefficient with AxSYM Valproic Acid assay. | 0.986 |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the clinical performance study (test set) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that clinical performance demonstrated substantial equivalency with a correlation coefficient of 0.986.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not include information on experts, ground truth establishment, or their qualifications for the clinical performance study. This type of information is typically not required for an immunoassay 510(k) where the comparison is against an existing, legally marketed device. The "ground truth" in this context would likely be the measurements from the predicate device itself.
4. Adjudication Method for the Test Set
The provided text does not mention any adjudication method. This is expected as the study is a comparison between two quantitative assays, not a study involving subjective interpretations that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a quantitative immunoassay meant for direct measurement, not an imaging device or diagnostic tool that involves human readers interpreting results in a comparative effectiveness setting. The study focused on the analytical performance of the new assay compared to a predicate device.
6. Standalone Performance
The clinical performance summary describes the standalone performance of the ARCHITECT iValproic Acid assay by demonstrating its correlation with the predicate AxSYM Valproic Acid assay. The correlation coefficient of 0.986 directly reflects the algorithm's (immunoassay's) performance in measuring valproic acid.
7. Type of Ground Truth Used
The "ground truth" for the clinical performance study was the measurements obtained from the legally marketed predicate device, the AxSYM Valproic Acid assay. The study aimed to show substantial equivalency of the new device's measurements to those of the predicate device.
8. Sample Size for the Training Set
The provided text does not specify a sample size for the training set. Immunoassay development typically involves extensive internal validation and optimization, but the regulatory submission focuses on the performance of the final assay.
9. How the Ground Truth for the Training Set was Established
The provided text does not detail how ground truth was established for a training set. For an immunoassay, training would involve optimizing reagents, protocols, and calibration curves using known concentrations or reference materials. The "ground truth" for these processes would be the expected or known concentrations of valproic acid in standards and controls used during development and calibration, rather than expert consensus on patient data.
§ 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.