(140 days)
The Abbott Aeroset® Carbamazepine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of carbamazepine in human serum or plasma on intended for as in the quarkhatr. 900367). Monitoring serum carbamazepine concentrations, the Abbot Acresul clinical assessment, is the most effective means of improving seizure control, along with barchar oliniour associeting the need for additional anticonvulsant medication for the following reasons (1, 2):
- Serum carbamazepine concentrations correlate better with pharmacologic activity than does . dosage.
- Changes in carbamazepine's half-life with prolonged treatment and interindividual . Official of Carbamazepine of name it difficult to predict serum levels from the differed dosage, particularly during concomitant therapy with other anticonvulsants. Serum level monitoring helps physicans individualize dosage regimens.
Carbamazepine is safe and effective only in a narrow range of serum concentrations. . Carbamazepine-10,11-epoxide, a major metabolite of carbamazepine, is pharmacologically active and found in plasma and tissues (3).
Methods historically used to monitor serum carbamazepine concentrations include gas-liquid chromatography, high-performance liquid chromatography, and immunoassay (1,2,4,5).
The Abbott Aeroset® Carbamazepine Assay is a homogenous enzyme assay intended for use in quantitative analysis of carbamazepine in human serum or plasma. The Abbott Aeroset® Carbamazepine Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Carbamazepine Assay (K913066) with regard to intended use, assay sample, and overall performance characteristics.
This Abbott Aeroset Carbamazepine Assay 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria for standalone performance against clinical outcomes. Therefore, the information provided reflects this equivalence-based approach.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation to Predicate Method | Coefficient of variation (%CV) for within-run precision: 1.42% to 2.88% |
| > 0.95 (implied good correlation from predicate equivalence) | Coefficient of variation (%CV) for total precision: 2.74% to 3.28% |
| Precision: | Correlation of 0.99 with a slope value of 1.06 to the predicate method (Emit® 2000 Carbamazepine Assay K913066). |
| Acceptable within-run precision (implied by "demonstrated acceptable within-run precision") | |
| Acceptable total precision (implied by "demonstrated acceptable total precision") |
2. Sample Size Used for the Test Set and Data Provenance
Specific sample sizes for the comparative analysis and precision studies are not explicitly stated in the provided document. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. For this in vitro diagnostic device (IVD), the "ground truth" for evaluating the new assay's performance is typically established by comparing its results to a legally marketed predicate device (Emit® 2000 Carbamazepine Assay). This is a quantitative comparison, not one requiring expert interpretation of primary data like images or clinical cases.
4. Adjudication Method for the Test Set
Not Applicable. As mentioned above, the comparison is quantitative against a predicate device, not involving human expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for devices where human readers interpret data (e.g., imaging devices) and the AI aims to assist or replace them. This is an in vitro diagnostic assay for chemical analysis, so an MRMC study is not applicable.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, implicitly. The reported performance characteristics (correlation and precision) are for the Abbott Aeroset® Carbamazepine Assay as a standalone analytical device. There's no mention of human-in-the-loop performance; it's a quantitative measurement system.
7. The Type of Ground Truth Used
The ground truth used for comparison was the results obtained from the legally marketed predicate device, the Emit® 2000 Carbamazepine Assay (K913066).
8. The Sample Size for the Training Set
Not applicable/Not explicitly stated. For traditional in vitro diagnostic assays like this homogeneous enzyme immunoassay, there isn't a "training set" in the sense of machine learning algorithms. The assay development involves optimizing reagents and protocols, but not training an algorithm on a specific dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no "training set" in the machine learning sense for this type of device. The assay itself is a chemical reaction-based system.
§ 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.