(56 days)
The GENT FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure gentamicin, an aminoglycoside antibiotic drug, in human specimens. Measurements obtained by this assay are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
The GENT method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-gentamicin conjugate and gentamicin-specific monoclonal antibody.
This document describes a 510(k) submission for the Gentamicin FLEX™ Reagent Cartridge. The information provided is for a chemical assay for an in vitro diagnostic device, not an AI/ML-driven device. Therefore, many of the requested categories related to AI validation (e.g., sample size for AI, ground truth establishment, MRMC studies, expert qualifications) are not applicable or cannot be answered from the provided text.
Here's the information that can be extracted or reasonably inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document states the GENT FLEX™ reagent cartridge is "substantially equivalent to the Abbott AxSYM® Gentamicin assay." Substantial equivalence is the primary acceptance criterion for 510(k) devices. This is demonstrated by comparing performance metrics, specifically method comparison data.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Correlation with Predicate Device: | |
| - Slope close to 1.0 | 1.02 |
| - Intercept close to 0.0 | -0.15 |
| - High correlation coefficient (R) | 0.987 |
| Measurement Range: | 0.1-10.6 µg/mL |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 197 samples
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, for an in vitro diagnostic assay, these would typically be human serum or plasma samples. The context suggests these were likely clinical or spiked samples used in a laboratory setting for method comparison. It does not specify if they are retrospective or prospective.
3. Number/Qualifications of Experts for Ground Truth
- Not Applicable. For a chemical assay demonstrating substantial equivalence, "ground truth" is established by the performance of the predicate device (Abbott AxSYM® Gentamicin assay) and clinical utility for measuring gentamicin. There are no "experts" establishing a diagnostic ground truth in the sense of image interpretation.
4. Adjudication Method
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for diagnostic interpretations (e.g., radiology, pathology) to resolve discrepancies. This is a method comparison study for an analytical measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not relevant for a chemical assay. MRMC studies are used to assess human reader performance, often in diagnostic imaging, with and without AI assistance. This device is not an AI.
6. Standalone Performance Study
- Yes (in an analytical sense). The study presents the standalone analytical performance of the GENT FLEX™ reagent cartridge by comparing its results to a predicate device. The device's performance (slope, intercept, correlation coefficient) is reported as measured directly. This is an "algorithm only" type of performance, where the "algorithm" is the PETINIA technique.
7. Type of Ground Truth Used
- Comparative Reference Method: The "ground truth" for this study is effectively the results obtained from the Abbott AxSYM® Gentamicin assay, which serves as the predicate device. The study aims to demonstrate that the new device yields comparable results to an already FDA-cleared method.
8. Sample Size for Training Set
- Not Applicable. This is not an AI/ML device that requires a distinct "training set." The development of the assay (reagent formulation, calibration) would involve internal R&D, but there isn't a specified "training set" in the context of AI model development.
9. How Ground Truth for Training Set Was Established
- Not Applicable. As above, there's no concept of a "training set" ground truth in the AI sense for this type of device. The assay development would rely on analytical chemistry principles and internal method validation.
§ 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.