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510(k) Data Aggregation
(28 days)
| Homogeneous Particle-Enhanced Turbidimetric Immunoassay |
| Device Classification: | 21 CFR 862.3035
Indianapolis, IN 46268-5620
Re: K052815
Trade/Device Name: QMS® Amikacin Regulation Number: 21 CFR 862.3035
The QMS® Amikacin assay is intended for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.
The QMS® Amikacin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.
In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS Amikacin Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance.
The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the drug. The absorbance of unknown samples can be interpolated from the absorbance values of the calibration curve and the concentration of the drug present in the sample can be calculated.
The assay consists of reagents R1: anti-amikacin monoclonal antibody and R2: amikacin-coated microparticles. A six-level set of QMS® Amikacin Calibrators (A through F) is used to calibroothe assay.
Here's a breakdown of the acceptance criteria and study information for the QMS® Amikacin assay, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | % Recovery: 100 ± 10% | Mean Percent Recovery: 94.02% (Specific recoveries: 95.87% for 9.2 µg/mL and 92.17% for 18.4 µg/mL) - Meets criteria |
| Linearity | Correlation coefficient (R2) demonstrating linearity | Correlation Coefficient (R2): 0.9998 (Mean Percent Recovery: 100.41% over a range of 1.5 to 42.5 µg/mL; specific recoveries from 95.71% to 111.33%) - Meets criteria |
| Sensitivity | Claimed LDD: 0.8 µg/mL | Average LDD: 0.54 µg/mL - Exceeds claimed performance (better sensitivity) |
| Assay Range | Not explicitly stated as acceptance criteria, but derived from other data | Reportable Range: 1.5 to 50 µg/mL (Based on Accuracy, Linearity, and Sensitivity data) |
| Method Comparison | Excellent correlation with predicate device | Correlation to Abbott TDx/TDxFLx Amikacin: N = 56, Slope = 1.00, y-intercept = 0.25, R = 0.996, R2 = 0.992. Results show excellent correlation. - Meets criteria |
| Precision | Total CV: |
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(177 days)
Antrim United Kingdom BT29 4QY
K033884 Re:
Trade/Device Name: Amikacin Regulation Number: 21 CFR 862.3035
The Randox Laboratories Limited Amikacin Test Kit is an in vitro diagnostic reagent for the quantitative determination of amikacin in serum. Measurements obtained by this device are used in the diagnosis and treatment of patients receiving therapy with amikacin by monitoring levels of amikacin to ensure appropriate therapy.
The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with amikacin, which in the presence of amikacin antibody Solution, agglutinate. When a sample containing amikacin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is measured in scattered light as a change in absorbance. By monitoring the change in absorbance the concentration of amikacin in the sample can be determined. The change in absorbance is inversely proportional to the concentration of amikacin in the sample.
The provided text is a 510(k) premarket notification approval letter for the Randox Laboratories Ltd. Amikacin Test Kit. This document does not describe a study involving detailed acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, or adjudication methods in the context of image analysis or diagnostic performance as typically seen for AI/ML devices.
Instead, this document is a regulatory approval for an in vitro diagnostic reagent for quantitative determination of amikacin in serum using a latex-enhanced immunoturbidimetric assay. The "performance" in this context refers to the assay's chemical and analytical characteristics (e.g., sensitivity, specificity, linearity, precision), which are typically established through laboratory validation studies, not clinical studies with human readers or ground truth established by experts in the same way as an AI diagnostic device.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying that its analytical performance has been demonstrated to be comparable to existing tests for the same purpose.
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(78 days)
Re: K032279
Trade/Device Name: Roche Diagnostics ONLINE TDM Amikacin Regulation Number: 21 CFR 862.3035
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.
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