(28 days)
For in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of gentamicin in serum or plasma, as an aid in monitoring the therapeutic administration of this aminoglycoside.
IMMULITE® 2000 Gentamicin is a solid-phase chemiluminescent enzyme immunoassay for use with the IMMULITE® 2000 Automated Analyzer.
Acceptance Criteria and Study for IMMULITE® 2000 Gentamicin
The IMMULITE® 2000 Gentamicin device's performance was evaluated by comparing it to a predicate device, the Abbott AxSYM® Gentamicin. The acceptance criteria essentially revolved around demonstrating substantial equivalence in measuring gentamicin concentrations in human specimens.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied by Comparison) | Reported Device Performance (IMMULITE® 2000 vs. Abbott AxSYM® Gentamicin) |
|---|---|---|
| Correlation | Strong linear correlation (e.g., r > 0.95) | r = 0.973 |
| Linearity | Close agreement in slope and intercept | (IMMULITE 2000) = 0.94 (Abbott AxSYM® Gentamicin) + 0.2 µg/mL |
| Bias | Minimal difference in mean concentrations | Means: 3.0 µg/mL (IMMULITE 2000) vs. 2.9 µg/mL (Abott AxSYM®) |
| Range Tested | Clinically relevant concentration range | 0.5 to 8.0 µg/mL |
Note: The document does not explicitly state pre-defined quantitative acceptance criteria. The "Acceptance Criteria (Implied by Comparison)" are inferred from the typical standards for demonstrating substantial equivalence against a predicate device in method comparison studies.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 89 patient samples.
- Data Provenance: Not explicitly stated, but based on the nature of the device (in vitro diagnostic for monitoring drug levels in human specimens), it is prospective, collected from patients. The country of origin is not specified, but the manufacturer is based in the USA.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The ground truth for the test set was established by the predicate device (Abbott AxSYM® Gentamicin), not through expert consensus.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: None. The comparison was directly between the IMMULITE® 2000 and the predicate device's measurements for each sample.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This is an in vitro diagnostic device for quantitative measurement, not an imaging or diagnostic interpretation device that typically involves human readers.
6. Standalone Performance Study
- Standalone Performance Study: Yes, in the sense that the IMMULITE® 2000 Gentamicin's measurements were observed independently. However, its performance was evaluated and understood in the context of comparison to the predicate device. The results (linear regression, correlation coefficient, means) represent the standalone performance relative to a reference.
7. Type of Ground Truth Used
- Type of Ground Truth: Measurements from a legally marketed and accepted predicate device (Abbott AxSYM® Gentamicin).
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not explicitly mention a separate "training set" in the context of an AI/machine learning model. The IMMULITE® 2000 Gentamicin is a chemiluminescent immunoassay, a chemical assay, not an AI-powered algorithm that requires a training set in the typical sense. Its calibration would rely on reference standards rather than a "training set" of patient data.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, this is a chemical immunoassay, not an AI algorithm. Calibration and quality control for such assays typically involve known concentrations of gentamicin standards, which serve as the reference for accurate measurement.
§ 862.3450 Gentamicin test system.
(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.