(60 days)
- For in vitro diagnostic use only. VITROS Chemistry Products TOBRA Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure tobramycin (TOBRA) concentration in human serum and plasma. Serum or plasma tobramycin measurements are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
- For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 14 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of tobramycin (TOBRA).
- For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and TOBRA on VITROS Chemistry Systems.
The VITROS Chemistry Products TOBRA Reagent, VITROS Chemistry Products Calibrator Kit 14, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS TOBRA assay. VITROS Chemistry Products TOBRA Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure tobramycin.
VITROS Chemistry Products Calibrator Kit 14 and TDM Performance Verifiers are packaged and sold separately.
VITROS Chemistry Products Calibrator Kit 14 is a liquid ready to use calibrator set for tobramycin. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters.
VITROS Chemistry Products TDM Performance Verifier I, II and III are liquid ready to use controls with assayed values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the VITROS Chemistry Products TOBRA Reagent:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (VITROS TOBRA Assay) |
|---|---|---|
| Intended Use | Quantitative measurement of tobramycin | Quantitative measurement of tobramycin |
| Basic Principle | Homogeneous enzyme immunoassay | Homogeneous enzyme immunoassay |
| Reportable Range | 0.6 – 10 µg/mL | 0.6 – 10 µg/mL |
| Reagents | Liquid ready to use | Liquid ready to use |
| Instrumentation | SYVA-30R Biochemical System | VITROS 5,1 FS Chemistry System |
| Sample Type | Serum and plasma | Serum and plasma |
| Correlation (vs. Predicate) | Implicitly 0.997 (achieved by predicate) | 0.997 (correlation coefficient) |
| Regression Slope | Implicitly 1.01 (achieved by predicate) | 1.01 (from VITROS TOBRA assay = 1.01 X + 0.00) |
| Regression Intercept | Implicitly 0.00 µg/mL (achieved by predicate) | 0.00 µg/mL (from VITROS TOBRA assay = 1.01 X + 0.00) |
Notes on Acceptance Criteria: The document primarily uses the predicate device's characteristics and performance as the benchmark for demonstrating substantial equivalence. The specific "acceptance criteria" are therefore derived from the predicate's known performance and characteristics.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number but refers to "patient samples."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that it compares performance to an existing predicate device using a set of samples. Given the submission date and the context, it's highly likely to be US-based, but this is not confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is an IVD device measuring a chemical substance. The "ground truth" for the test set would be established by the reference method (the predicate device) or a known reference standard, not by human expert consensus or interpretation.
4. Adjudication method for the test set
Not applicable. Refer to point 3.
5. 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
Not applicable. This is an In Vitro Diagnostic (IVD) device for quantitative measurement of a substance, not an imaging or diagnostic aid for human readers/clinicians, nor does it typically involve AI assistance in the context of human interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the study describes the standalone performance of the VITROS TOBRA assay. The device measures tobramycin concentration without direct human-in-the-loop diagnostic interpretation of results (though results are interpreted by healthcare professionals). The performance evaluation involved comparing its measurements directly to those of the predicate device and assessing core analytical performance characteristics.
7. The type of ground truth used
The primary "ground truth" for comparison was assumed to be the readings from the predicate device (SYVA Emit 2000 Tobramycin Assay) using patient samples. Additionally, analytical studies (precision, linearity, specificity) would rely on known concentrations of tobramycin standards/samples.
8. The sample size for the training set
Not applicable in the context of this traditional IVD device. The VITROS TOBRA assay is based on a homogeneous enzyme immunoassay principle, not a machine learning algorithm that requires a "training set" in the conventional sense. Its "training" is inherent in its chemical design and calibration process.
9. How the ground truth for the training set was established
Not applicable. Refer to point 8.
§ 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.