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510(k) Data Aggregation
(167 days)
ROCHE ONLINE TDM QUINIDINE
The Roche ONLINE TDM Quinidine assay is for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers. Quinidine is used for the numan sorant of practicular arththmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic supraventicular (urrry annos) formulation, patient age, and individual variability in 2010, 0 Scruit levels is depondent on the proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Quinidine reagent kits.
The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with quinidine and rapidly aggregate in the presence of a quinidine antibody solution. When a sample containing quinidine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to quinidine concentration is obtained, with the maximum rate of aggregation at the lowest quinidine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.
Below is a summary of the acceptance criteria and study information for the Roche ONLINE Quinidine Assay, based on the provided text.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets in the provided text. However, the study aims to demonstrate substantial equivalence to a predicate device (Roche COBAS INTEGRA Quinidine Assay) and an Enzyme Immunoassay by showing comparable precision and method correlation. The reported device performance is presented in comparison to these predicate methods.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Roche ONLINE TDM Quinidine Reported Performance |
|---|---|---|
| Method Comparison | Versus Roche COBAS INTEGRA Quinidine Assay | |
| Correlation (R) | 0.991 (Predicate) | 0.991 |
| Regression (Y=mX+b) | Y = 1.054X - 0.036 (Predicate) | Y = 1.054X - 0.036 |
| Range | 0.16 to 5.7 µg/mL (Predicate) | 0.22 to 7.04 µg/mL |
| Versus Enzyme Immunoassay | ||
| Correlation (R) | 0.991 (Predicate) | 0.991 |
| Regression (Y=mX+b) | Y = 0.941X - 0.024 (Predicate) | Y = 0.941X - 0.024 |
| Range | Not explicitly stated for EIAA | 0.16 to 5.7 µg/mL |
| Precision (Level 1) | ||
| Mean (µg/mL) | 1.35 (Predicate) | 0.93 |
| CV% (within run) | 2.1 (Predicate) | 2.0 |
| CV% (total) | 3.2 (Predicate) | 3.9 |
| Precision (Level 2) | ||
| Mean (µg/mL) | 3.47 (Predicate) | 2.87 |
| CV% (within run) | 2.2 (Predicate) | 1.3 |
| CV% (total) | 3.5 (Predicate) | 2.7 |
| Precision (Level 3) | ||
| Mean (µg/mL) | 5.42 (Predicate) | 4.61 |
| CV% (within run) | 2.0 (Predicate) | 1.2 |
| CV% (total) | 3.2 (Predicate) | 2.7 |
2. Sample Size and Data Provenance for the Test Set
- Sample Size (Method Comparison):
- N = 150 (for comparison against Roche COBAS INTEGRA Quinidine Assay)
- N = 154 (for comparison against Enzyme Immunoassay)
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This information is not applicable as the device is an in-vitro diagnostic assay for quinidine quantification, not an imaging or diagnostic AI with subjective interpretation requiring human experts for ground truth establishment. The performance is assessed against established laboratory methods.
4. Adjudication Method (Test Set)
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., radiologists reading images), which is not the case for this automated immunoassay.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was done. The entire study focuses on the performance of the "Roche ONLINE TDM Quinidine" assay itself, in comparison to other existing assays. There is no mention of human-in-the-loop performance; the device is automated for quantitative determination.
7. Type of Ground Truth Used
The ground truth used for comparison was the results obtained from:
- The Roche COBAS INTEGRA Quinidine Assay (predicate device).
- An Enzyme Immunoassay.
The performance of these established methods served as the reference for determining the new device's accuracy and precision.
8. Sample Size for the Training Set
The provided text does not contain information regarding a specific training set or its sample size. This type of submission (510(k) for an in-vitro diagnostic) focuses on validation and comparison to a predicate, rather than the development and training of a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the method for establishing its ground truth is not applicable from the provided text.
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