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510(k) Data Aggregation
(28 days)
KLQ
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)
KLQ
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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(65 days)
KLQ
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