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510(k) Data Aggregation
(91 days)
MULTIGENT GENTAMICIN
The Multigent® Gentamicin assay is intended for the quantitative determination of Gentamicin in human serum or plasma on the Architect C8000 System. The results obtained are used in the diagnosis and treatment of Gentamicin overdose and in monitoring levels of Gentamicin to ensure appropriate therapy.
The Multigente Gentamicin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti-gentamicin monoclonal antibody and R2: gentamicin-coated microparticles. A six-level set of Multigent" Gentamicin Calibrators (A through F) is used to calibrate the assay.
This document describes the acceptance criteria and the studies performed to demonstrate the performance of the Multigent® Gentamicin assay.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (Recovery) | 100 ± 10% or 0.1 µg/mL | Concentration (µg/mL) |
| 0.25 | 102.67% | |
| 1.00 | 99.67% | |
| 2.25 | 98.81% | |
| 4.50 | 99.33% | |
| 8.00 | 101.08% | |
| Mean Percent Recovery: 100.31% | ||
| Linearity (Recovery) | 100 ± 10% | Concentration (µg/mL) |
| 6.88 | 104.60% | |
| 5.16 | 102.20% | |
| 3.44 | 105.14% | |
| 1.72 | 95.35% | |
| Mean Percent Recovery: 101.82% | ||
| Sensitivity (LDD) | Not explicitly stated in the "Acceptance Criteria" column, but the goal is to claim 0.1 µg/mL. | The average LDD is 0.09 µg/mL. This supports a claim of 0.1 µg/mL. |
| Interference (Bilirubin) | 100 ± 10% | Mean Recovery: 3.42 µg/mL for a target of 3.44 µg/mL. (% Recovery for 20mg/dL Bilirubin: 99.42% (calculated from data). The table has an error in displaying this value.) |
| Interference (Hemoglobin) | 100 ± 10% | Mean Recovery: 3.38 µg/mL for a target of 3.44 µg/mL. (% Recovery for 2g/dL Hemoglobin: 98.26%) |
| Interference (Triglyceride) | 100 ± 10% | Mean Recovery: 3.30 µg/mL for a target of 3.44 µg/mL. (% Recovery for 1691 mg/dL Triglyceride: 95.83%) |
| Interference (Total Protein) | 100 ± 10% | Mean Recovery: 3.21 µg/mL for a target of 3.44 µg/mL. (% Recovery for 12 g/dL Total Protein: 93.41%) |
| Interference (Rheumatoid Factor) | 100 ± 10% | Mean Recovery: 3.26 µg/mL for a target of 2.46 µg/mL. (% Recovery for 582 IU Rheumatoid Factor: 132.34%) - This value exceeds the acceptance criteria of 100 ± 10%. |
| Interference (HAMA Type-1) | 100 ± 10% | Mean Recovery: 3.30 µg/mL. (% Recovery: 99.10%) |
| Interference (HAMA Type-2) | 100 ± 10% | Mean Recovery: 3.08 µg/mL. (% Recovery: 93.34%) |
| Method Comparison (Correlation with Predicate) | High correlation (e.g., R-squared close to 1) | N = 55, Slope = 1.165, y-intercept = -0.719, R = 0.996, R² = 0.992. "Results show excellent correlation between the two assays." |
| Precision | CV (%) ranges from 1.07% to 5.69% for various control levels (details in document for within-run, between-day, between-run, and total precision). | Low Control (2.68 µg/mL): Total CV 5.69%, SD 0.15 |
| Mid Control (6.47 µg/mL): Total CV 2.44%, SD 0.16 | ||
| High Control (9.41 µg/mL): Total CV 2.15%, SD 0.20 | ||
| (Full details for within-run, between-day, and between-run are available in the provided text, and all appear to be within acceptable limits for an immunoassay.) | ||
| On-Board Stability (Calibration Curve) | Data supports the stability period | 28 days |
| On-Board Stability (Reagent) | Data supports the stability period | 40 days |
| Anticoagulants | No significant difference in recovery with various anticoagulants | "The results indicate that there is no significant difference between the recovery of Gentamicin in serum or plasma. The collection tubes evaluated show no adverse effects on the recovery of Gentamicin, within the experimental error for the spiking study." |
Note regarding Rheumatoid Factor interference: The reported % Recovery (132.34%) for Rheumatoid Factor at 582 IU exceeds the stated acceptance criteria of 100 ± 10%. This indicates potential interference from high levels of Rheumatoid Factor, which should be noted in the device labeling.
2. Sample Size and Data Provenance:
- Accuracy: 5 samples (0.25, 1.00, 2.25, 4.50, 8.00 µg/mL) each run in triplicate (total of 15 measurements in the table shown). Data provenance not specified (retrospective/prospective, country of origin).
- Linearity: 4 serially diluted samples (6.88, 5.16, 3.44, 1.72 MG/ML) each run in triplicate (total of 12 measurements in the table shown). Data provenance not specified.
- Precision: 3 control levels (low, mid, high) tested, with N=80 for each (number of replicates over time). Data provenance not specified.
- Sensitivity: Calibrator A (0 µg/mL) run for a total of 20 replicates. Data provenance not specified.
- Interferences (Endogenous Substances):
- Bilirubin: 3 replicates for "N=3" (interpreted as the number of independent samples or measurement replicates, as the "N" column is inconsistent).
- Hemoglobin: 2 replicates for "N=2".
- Triglyceride, Total Protein: "N" is listed as a non-numeric character (presumably an error in transcription, but the text mentions "run in triplicate" for triglyceride and total protein).
- Rheumatoid Factor: "N" is listed as a non-numeric character (text mentions "run in triplicate").
- Data provenance not specified.
- Interferences (HAMA): Duplicate HAMA samples (Type-1 and Type-2) and duplicate control samples. Data provenance not specified.
- Interferences (Common Co-Administered Drugs): Test samples and control samples assayed in duplicate for each drug. Data provenance not specified.
- Anticoagulants: Blood drawn from at least ten healthy donors for each of the 9 tube types. Samples were spiked with Gentamicin and run in duplicate. Data provenance not specified.
- Method Comparison: 55 serum and plasma samples, ranging from 0.78 to 9.02 µg/mL Gentamicin. Data provenance not specified.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an in vitro diagnostic (IVD) assay for quantitative determination of a drug concentration. The "ground truth" for chemical concentration assays is typically established by reference methods, primary standards, or gravimetric/volumetric preparation of known concentrations. There is no mention of human "experts" establishing ground truth in the traditional sense of clinical opinion (e.g., radiologists, pathologists). The ground truth for performance studies like accuracy and linearity is based on the theoretical concentrations of prepared samples or reference materials. For method comparison, the predicate device (Abbott TDx®/TDxFLx® Gentamicin assay) serves as the reference method.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in studies involving subjective assessment (e.g., image interpretation) where multiple readers provide independent evaluations that might conflict. For quantitative chemical assays, the result is a numerical value, and "adjudication" is not a standard practice. Statistical methods are used to compare results to expected values or reference methods.
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 is an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The performance studies described (Precision, Accuracy, Linearity, Sensitivity, etc.) represent the standalone performance of the Multigent® Gentamicin assay system. The device itself generates a quantitative result without direct human interpretation of a visual output. The human-in-the-loop would be the laboratory personnel operating the Architect C8000 System and interpreting the numerical result in a clinical context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for this device's performance relies on:
- Theoretical Concentrations: For accuracy, linearity, and sensitivity studies, known concentrations of Gentamicin in control matrices serve as the ground truth. These are typically prepared using gravimetric or volumetric methods with highly pure reference standards.
- Reference Method: For the method comparison study, the Abbott TDx®/TDxFLx® Gentamicin assay served as the reference (or comparative) method, with its results considered the "ground truth" for evaluating the new device's correlation.
8. The sample size for the training set:
Not applicable. This device is a chemical immunoassay, not a machine learning or artificial intelligence system that requires a "training set" in the computational sense. The assay works based on established biochemical principles and reagents rather than being "trained" on data.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of in vitro diagnostic device.
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