(56 days)
The TOBR FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
The TOBR method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-tobramycin conjugate and tobramycin-specific monoclonal antibody.
This document does not contain all the requested information, but here's an analysis of what is available:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for the device's performance in a tabular format. However, it provides comparative performance data against a predicate device.
| Performance Metric | Reported Device Performance (TOBR FLEX™ vs. aca® TOBRA) |
|---|---|
| Slope | 0.99 |
| Intercept | 0.10 |
| Correlation Coefficient | 0.989 |
| Range of Samples | 0-12 µg/mL |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: 141 samples
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It simply says "One hundred forty-one samples were tested."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable or not provided. The ground truth for this device (measuring tobramycin levels) would likely be based on a reference standard or the predicate device's accepted measurement, not expert consensus in the human interpretation sense.
4. Adjudication Method for the Test Set:
Not applicable or not provided. This is a quantitative measurement device; adjudication methods are typically used for qualitative or interpretive tasks involving multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a point-of-care or lab-based diagnostic device for measuring a chemical compound, not an imaging or interpretive AI system evaluated with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, this is a standalone device. The performance metrics provided (slope, intercept, correlation coefficient) describe the algorithm's analytical performance on its own, comparing its measurements to those of the predicate device. There is no human intervention in the "measurement" process described.
7. Type of Ground Truth Used:
The "ground truth" for the performance evaluation appears to be the measurements obtained by the aca® TOBRA test pack, which is the predicate device. The study aims to demonstrate substantial equivalence to this already cleared device.
8. Sample Size for the Training Set:
Not provided. The document describes a comparison study, not the development or training of an algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable as training set information is not provided.
§ 862.3900 Tobramycin test system.
(a)
Identification. A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.(b)
Classification. Class II.