(65 days)
The ONLINE TDM Vancomycin assay is for the quantitative determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
The ONLINE TDM Vancomycin assay is for the quantitative determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Vancomycin reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of vancomycin in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay.
The provided document describes the ONLINE TDM Vancomycin assay, intended for the quantitative determination of vancomycin in human serum or plasma.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet. Instead, it presents performance characteristics (precision and method comparison) and states that "All of the evaluation studies gave acceptable results compared to the predicate device." The comparison is implicitly against the performance of the predicate device, COBAS INTEGRA Vancomycin (K954992).
The table below summarizes the reported performance of the new device and the predicate device for comparison:
| Performance Characteristic | ONLINE TDM Vancomycin (New Device) | COBAS INTEGRA Vancomycin (Predicate Device) | Implied Acceptance/Description |
|---|---|---|---|
| NCCLS Precision, Within run | "Acceptable results compared to the predicate device." | ||
| Control 1 Mean (µg/ml) | 6.8 | 3.8 | |
| Control 1 SD (µg/ml) | 0.34 | 0.08 | |
| Control 1 CV% | 4.9 | 2.2 | |
| Control 2 Mean (µg/ml) | 21.0 | 8.6 | |
| Control 2 SD (µg/ml) | 0.29 | 0.17 | |
| Control 2 CV% | 1.4 | 1.9 | |
| Control 3 Mean (µg/ml) | 39.1 | 14.7 | |
| Control 3 SD (µg/ml) | 0.45 | 0.31 | |
| Control 3 CV% | 1.1 | 2.1 | |
| NCCLS Precision, Total | "Acceptable results compared to the predicate device." | ||
| Control 1 Mean (µg/ml) | 6.8 | 3.8 | |
| Control 1 SD (µg/ml) | 0.40 | 0.12 | |
| Control 1 CV% | 5.8 | 3.0 | |
| Control 2 Mean (µg/ml) | 21.0 | 8.6 | |
| Control 2 SD (µg/ml) | 0.60 | 0.24 | |
| Control 2 CV% | 2.9 | 2.8 | |
| Control 3 Mean (µg/ml) | 39.1 | 14.7 | |
| Control 3 SD (µg/ml) | 1.04 | 0.52 | |
| Control 3 CV% | 2.7 | 3.6 | |
| Method Comparison (ONLINE TDM Vancomycin Vs. COBAS INTEGRA Vancomycin) | Sample Size (N)=55, Range = 5.0-67.2 µg/ml | "Acceptable results compared to the predicate device." | |
| Linear Regression | y=1.038x - 0.094 | Desired: closer to y=x (slope 1, intercept 0). | |
| Correlation Coefficient (r) | 0.991 | Desired: closer to 1.0. |
Note on Method Comparison Table: The document's method comparison section is a bit confusing. It lists a "Linear Regression: ONLINE TDM Carbamazepine Vs. COBAS INTEGRA Carbamazepine (FPIA) method" for the new device and then "Linear Regression: COBAS INTEGRA Carbamazepine (FPIA) Vs. COBAS FARA II" for the predicate. Since the device under review is for Vancomycin, the listing of "Carbamazepine" in the method comparison for the new device appears to be a typographical error or an irrelevant comparison. Assuming this is a typo and should refer to Vancomycin, the listed regression equation and correlation coefficient are for the new device against the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Method Comparison (Test Set): N=55
- Data Provenance: Not explicitly stated in the document (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies listed are analytical performance studies (precision, method comparison) comparing the new device against a predicate device, not clinical studies involving expert interpretation of patient samples where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The studies are analytical performance comparisons, not clinical evaluations requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done for this device submission. This is an in-vitro diagnostic device measuring a chemical analyte, not an imaging or diagnostic interpretation device where human readers would be involved.
6. Standalone (Algorithm Only) Performance
The device itself is an automated assay, meaning its performance is inherently standalone (algorithm/analyzer only). The precision and method comparison studies directly evaluate this standalone performance. No human-in-the-loop performance is expected or evaluated for this type of device.
7. Type of Ground Truth Used
For the method comparison study, the "ground truth" or reference method was the predicate device, COBAS INTEGRA Vancomycin (K954992). The new device's measurements were compared against the measurements obtained by this established and legally marketed predicate device.
For the precision studies, the "ground truth" is typically the known concentration of vancomycin in control materials, against which the device's variability is assessed.
8. Sample Size for the Training Set
This information is not provided in the document. For an immunoassay like this, there isn't typically a "training set" in the machine learning sense. The device is developed and validated through analytical studies.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. As mentioned above, a "training set" in the machine learning context is not relevant for this type of immunoassay device. The assay development would involve optimizing reagents and conditions, and its performance is then characterized by analytical validation studies against known standards and comparative methods.
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.