(112 days)
The Chiron Diagnostics ACS:180 Tobramycin Assay is for the quantitative determination of tobramycin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence Systems. Monitoring the patient's serum or plasma tobramycin levels is important both to ensure that the drug is present in therapeutic concentrations and to avoid toxicity.
The Chiron Diagnostics ACS:180 Tobramycin assay is a competitive immunoassay using direct, chemilumenescent technology. Tobramycin in the patient sample competes with acradinium ester-labeled tobramycin in the Lite Reagent for a limited amount of monoclonal mouse anti-tobramycin antibody, which is covalently coupled to the paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of tobramycin present in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.
Here's a summary of the acceptance criteria and study details for the Chiron Diagnostics ACS:180 Tobramycin Assay, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity (Detection Limit) | Not explicitly stated, but implies detection of therapeutic concentrations | Minimum detectable concentration of 0.18 µg/mL |
| Measurement Range | Not explicitly stated, but implies coverage of therapeutic concentrations | Measures tobramycin concentration up to 13 µg/mL |
| Accuracy (Agreement with Predicate) | Not explicitly stated, but implied high correlation with an alternate method | Correlation coefficient (r) = 0.99 for 293 samples in the range of 0.22 to 9.03 µg/mL. Equation: ACS:180 Tobramycin = 0.903 (alternate method) + 0.10 µg/mL |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 293 samples.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The "ground truth" for the accuracy study was an "alternate fluorescence polarization (FPIA) method," which is a laboratory method, not expert-based.
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Adjudication method for the test set:
- Not applicable. The comparison was against a laboratory method.
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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:
- No. This device is an automated immunoassay for drug level measurement, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes. The performance described for the ACS:180 Tobramycin assay is its standalone, automated performance.
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The type of ground truth used:
- Alternative Method Comparison: The accuracy of the ACS:180 Tobramycin assay was assessed by comparing its results against an "alternate fluorescence polarization (FPIA) method." This constitutes a comparative method study, where the FPIA method serves as the reference or "ground truth."
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The sample size for the training set:
- Not provided. The document describes performance data, but does not detail the development or training of the assay (which, in this context, refers to the development of the immunoassay reagents and calibration, not an AI model).
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How the ground truth for the training set was established:
- Not provided. As this is not an AI/machine learning model in the conventional sense, the concept of a "training set" and its "ground truth establishment" as typically applied to AI does not directly apply in the same way. The development of an immunoassay involves optimizing reagent concentrations, antibody specificity, and calibration using known standards, but these details are not in the provided summary.
§ 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.