(78 days)
The ONLINE TDM Amikacin assay is for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.
The ONLINE TDM Amikacin assay is for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers. Determination of serum or plasma drug levels is required to achieve optimum therapeutic efficacy and minimize toxicity. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Amikacin reagent kits. The ONLINE TDM Amikacin 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 amikacin and rapidly aggregate in the presence of an amikacin antibody solution. When a sample containing amikacin 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 formation is inhibited. Thus, a classic inhibition curve with respect to amikacin concentration is obtained, with the maximum rate of aggregation at the lowest amikacin concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.
The provided document describes the Roche Diagnostics ONLINE TDM Amikacin assay, a device for the quantitative determination of amikacin in human serum or plasma. The primary study presented is a substantial equivalence comparison to a predicate device, the COBAS INTEGRA Amikacin assay (K991597).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each performance characteristic. Instead, it states that "All of the evaluation studies gave acceptable results compared to the predicate device." The performance reported is in comparison to the predicate device, implying that achieving comparable performance to the legally marketed predicate was the acceptance criterion.
| Performance Characteristic | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (ONLINE TDM Amikacin) | Predicate Device Performance (COBAS INTEGRA Amikacin) |
|---|---|---|---|
| NCCLS Precision, Within run | |||
| Control 1 Mean (µg/ml) | Comparable to 5.3 µg/ml | 5.43 µg/ml | 5.3 µg/ml |
| Control 1 SD (µg/ml) | Comparable to 0.29 µg/ml | 0.10 µg/ml | 0.29 µg/ml |
| Control 1 CV% | Comparable to 5.4% | 1.7% | 5.4% |
| Control 2 Mean (µg/ml) | Comparable to 14.3 µg/ml | 16.88 µg/ml | 14.3 µg/ml |
| Control 2 SD (µg/ml) | Comparable to 0.25 µg/ml | 0.23 µg/ml | 0.25 µg/ml |
| Control 2 CV% | Comparable to 1.8% | 1.4% | 1.8% |
| Control 3 Mean (µg/ml) | Comparable to 27.3 µg/ml | 33.27 µg/ml | 27.3 µg/ml |
| Control 3 SD (µg/ml) | Comparable to 0.58 µg/ml | 0.47 µg/ml | 0.58 µg/ml |
| Control 3 CV% | Comparable to 2.1% | 1.4% | 2.1% |
| NCCLS Precision, Total | |||
| Control 1 Mean (µg/ml) | Comparable to 5.3 µg/ml | 5.43 µg/ml | 5.3 µg/ml |
| Control 1 SD (µg/ml) | Comparable to 0.37 µg/ml | 0.15 µg/ml | 0.37 µg/ml |
| Control 1 CV% | Comparable to 7.0% | 2.8% | 7.0% |
| Control 2 Mean (µg/ml) | Comparable to 14.3 µg/ml | 16.88 µg/ml | 14.3 µg/ml |
| Control 2 SD (µg/ml) | Comparable to 0.36 µg/ml | 0.37 µg/ml | 0.36 µg/ml |
| Control 2 CV% | Comparable to 2.5% | 2.2% | 2.5% |
| Control 3 Mean (µg/ml) | Comparable to 27.3 µg/ml | 33.27 µg/ml | 27.3 µg/ml |
| Control 3 SD (µg/ml) | Comparable to 0.78 µg/ml | 0.68 µg/ml | 0.78 µg/ml |
| Control 3 CV% | Comparable to 2.9% | 2.0% | 2.9% |
| Method Comparison (Linear Regression) | |||
| N | Comparable to N=120 | N=89 | N=120 |
| Range | Comparable to 0.30 - 41.8 µg/ml | 0.4 - 39.9 µg/ml | 0.30 - 41.8 µg/ml |
| Equation | Comparable to y=0.914x + 0.511 | $y=0.869x + 0.159$ | $y=0.914x + 0.511$ |
| Correlation (r) | Comparable to r=0.987 | r=0.976 | r=0.987 |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For the method comparison study directly comparing the ONLINE TDM Amikacin to the COBAS INTEGRA Amikacin, the sample size was N=89. For the predicate device's method comparison (COBAS INTEGRA 700 Amikacin vs. Abbott TDx), the sample size was N=120.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an in-vitro diagnostic assay for quantitative determination of a drug level. Ground truth is established by the reference method's result (predicate device in this case), not by expert interpretation.
4. Adjudication method for the test set
Not applicable. As noted above, this is a quantitative analytical measurement, not a subjective interpretation requiring adjudication among experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an in-vitro diagnostic instrument measuring drug concentration and does not involve "human readers" or "AI assistance" in the typical sense of image interpretation or clinical decision support systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies reported are for the standalone performance of the ONLINE TDM Amikacin assay. The performance characteristics like precision, lower detection limit, method comparison, specificity, and interfering substances were evaluated for the device itself.
7. The type of ground truth used
The ground truth for the performance evaluation of the ONLINE TDM Amikacin assay was established by comparison to the predicate device, the COBAS INTEGRA Amikacin assay (K991597), which itself has an established analytical performance. For the method comparison, the COBAS INTEGRA Amikacin result was the comparative truth.
8. The sample size for the training set
The document does not specify a separate "training set" with a sample size. This is common for analytical devices where fundamental chemical/biological principles are used, and "training" as in machine learning is not directly applicable. The data presented are from validation/test sets.
9. How the ground truth for the training set was established
Not applicable, as a distinct training set in the machine learning sense is not described.
§ 862.3035 Amikacin test system.
(a)
Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.(b)
Classification. Class II.