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510(k) Data Aggregation
(89 days)
ONLINE TDM CARBAMAZEPINE
The ONLINE TDM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. This neuroleptic drug assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of carbamazepine.
The ONLINE TDM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. In combination with other clinical information, monitoring carbamazepine levels provides physicians with an effective tool to aid in adjusting dosage and achieving optimal therapeutic effect while avoiding both sub-therapeutic and toxic drug levels. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Carbamazepine reagent kits.
The ONLINE TDM Carbamazepine assay is a homogeneous microparticle agglutination immunoassay. It is a two-reagent system used for the detection of carbamazepine in serum. Kinetic interaction of microparticles (KIMS) will be measured using Roche Diagnostics / Hitachi families of automated analyzers. In this technology biotinylated drug hapten serves as the binding partner to 1.) anti-carbamazepine antibody and 2.) streptavidin coated latex A competitive reaction to a limited amount of specific antibeads. carbamazepine antibody takes place between the hapten and free carbamazepine in the serum sample. A decrease in the apparent signal is proportional to the amount of drug present in the sample.
Here's an analysis of the acceptance criteria and study details for the Roche ONLINE TDM Carbamazepine assay, based on the provided 510(k) summary:
The device being assessed is the Roche ONLINE TDM Carbamazepine assay.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Roche ONLINE TDM Carbamazepine assay are primarily inferred through comparison to its predicate device, the Roche COBAS INTEGRA Carbamazepine assay (K951595). The study aims to demonstrate substantial equivalence across key performance characteristics. The document doesn't explicitly state numerical "acceptance criteria" but rather presents the performance of both the new device and the predicate for direct comparison.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate Performance or General Standards for Substantial Equivalence) | Roche ONLINE TDM Carbamazepine Performance (New Device) |
|---|---|---|
| Precision (Within run) | Comparable to predicate: | Control 1 (2.8 µg/ml): SD 0.05, CV% 1.7 |
| - SD (µg/ml) | - Control 1: 0.08 | Control 2 (8.3 µg/ml): SD 0.13, CV% 1.5 |
| - CV% | - Control 2: 0.17 | Control 3 (14.1 µg/ml): SD 0.21, CV% 1.5 |
| - Control 3: 0.31 | ||
| Precision (Total) | Comparable to predicate: | Control 1 (2.8 µg/ml): SD 0.15, CV% 5.6 |
| - SD (µg/ml) | - Control 1: 0.12 | Control 2 (8.3 µg/ml): SD 0.36, CV% 4.3 |
| - CV% | - Control 2: 0.24 | Control 3 (14.1 µg/ml): SD 0.55, CV% 3.9 |
| - Control 3: 0.52 | ||
| Method Comparison | High correlation to predicate and linearity over relevant range (e.g., r > 0.95) | y=1.062x - 0.16, r=0.985 (N=103, Range = 0.5-11.93 µg/ml) |
| - Correlation (r) | ||
| - Regression Equation | ||
| Other (General) | Acceptable results provided for: Lower detection limit, specificity, 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 (Test Set):
- N = 103 for the comparison between the ONLINE TDM Carbamazepine and the COBAS INTEGRA Carbamazepine (FPIA) method.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for an in-vitro diagnostic, it is highly likely these were prospective clinical laboratory evaluations conducted as part of the validation process.
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 summary. For an in-vitro diagnostic device like this, the "ground truth" would typically refer to the reference method or comparative method results, which are obtained directly from laboratory measurements rather than expert consensus on images or clinical assessments.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology reads). This is an in-vitro diagnostic device (immunoassay) for quantitative determination of a drug level. Therefore, no adjudication method (in the sense of human expert disagreement resolution) was used or is relevant for this type of device performance evaluation. The "ground truth" is established through other laboratory methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for medical imaging devices where multiple human readers interpret cases. This device is an automated immunoassay, not an imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary evaluation presented is a standalone (algorithm only) performance study. The device is an automated clinical chemistry analyzer for quantitative determination of carbamazepine. Its performance (precision, method comparison) is assessed as a direct output of the instrument without human interpretation playing a role in the measurement itself, beyond standard laboratory procedures and quality control.
7. The Type of Ground Truth Used
The "ground truth" for the test set (method comparison) was established by using the predicate device's measurement (Roche COBAS INTEGRA Carbamazepine assay, specifically its FPIA method) as the comparative standard. The new device's results are then correlated against these predicate results. This is a common approach for demonstrating substantial equivalence for IVDs.
8. The Sample Size for the Training Set
The document does not provide information on a training set size. For an immunoassay, particularly one demonstrating substantial equivalence to a predicate, the development process might involve internal optimization and validation, but the 510(k) summary focuses on the final performance evaluation data presented to demonstrate equivalence. It's not a machine learning model that would typically have a distinct 'training set' in the way an AI algorithm does.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" (in the context of AI/ML) is mentioned, the method for establishing its ground truth is not applicable/not provided in this summary. Any internal development or optimization would rely on established laboratory reference methods for carbamazepine quantification.
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