(140 days)
The Abbott Aeroset® Phenytoin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenytoin in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenytoin concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anti-convulsant medication for the following reasons:
- Serum phenytoin concentrations correlate better with pharmacologic activity than does . dosage because of individual differences in absorption, metabolism, disease states, concomitant medication, and compliance. Serum concentration monitoring helps physicans individualize dosage regimens.
- The hepatic enzyme system for metabolizing phenytoin can become saturated within the . drug's therapeutic range. When this occurs, small dosage alterations can lead to unexpected drug accumulation and clinical toxicity.
- Phenytoin is safe and effective only in a narrow range of serum concentrations. .
- Methods historically used to monitor serum phenytoin concentrations include . chromatographic assays and immunoassays.
The Abbott Aeroset® Phenytoin Assay is a homogenous enzyme assay intended for use in quantitative analysis of Phenytoin in human serum or plasma.
The Abbott Aeroset Phenytoin Assay device is a homogeneous enzyme immunoassay intended for the quantitative analysis of phenytoin in human serum or plasma.
Here's an analysis of the provided information:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparative Analysis: Equivalent to predicate device (Emit® 2000 Phenytoin Assay) with strong correlation. | Comparative Analysis: Correlation of 1.0 with a slope value of 1.04 to the predicate method. |
| Precision (Within-run %CV): Acceptable | Precision (Within-run %CV): Ranging from 1.67% to 1.83% |
| Precision (Total %CV): Acceptable | Precision (Total %CV): Ranging from 2.82% to 3.54% |
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "A Precision study was performed" and "The comparative analysis to the predicate method".
3. Number of Experts and Qualifications
This information is not provided in the document. The nature of this in vitro diagnostic device (quantitative analysis of a chemical compound) typically relies on laboratory measurements and comparison to a predicate device rather than expert interpretation of images or clinical cases.
4. Adjudication Method
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of data (e.g., medical images) to establish ground truth from multiple experts. For this device, the performance is based on analytical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This type of study assesses how AI assistance impacts human reader performance, which is not relevant for a standalone analytical assay like the Abbott Aeroset Phenytoin Assay.
6. Standalone Performance
Yes, a standalone performance was done. The document describes the "Comparative Analysis" and "Precision" studies of the Abbott Aeroset Phenytoin Assay, which represent its performance without human-in-the-loop assistance for the core measurement. The device's output is a quantitative value.
7. Type of Ground Truth Used
The ground truth for the "Comparative Analysis" was the results obtained from the predicate device, Emit® 2000 Phenytoin Assay (K913429). For the "Precision" study, typical ground truth would be based on expected values for control samples or replicate measurements.
8. Sample Size for the Training Set
This information is not provided. For an enzyme immunoassay, the "training set" would typically refer to the data used for assay development, optimization, and calibration curve generation. The document does not detail this.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. For an immunoassay, the training set's ground truth would likely be established through:
- Reference materials: Known concentrations of phenytoin used to create calibration curves.
- Analytical methods: Independent, highly accurate analytical methods (e.g., GC-MS or HPLC) to confirm the concentrations of standards and controls.
- Predicate device results: If the assay was benchmarked against an existing method during development, results from the predicate device would also serve as a form of ground truth for method development.
§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.