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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

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.

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