(115 days)
- For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
- For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT).
- 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 GENT on VITROS Chemistry Systems.
The VITROS Chemistry Products GENT Reagent. VITROS Chemistry Products Calibrator Kit 13, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS GENT assay. VITROS Chemistry Products GENT Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure gentamicin. VITROS Chemistry Products Calibrator Kit 13 and TDM Performance Verifiers are packaged and sold separately. VITROS Chemistry Products Calibrator Kit 13 is a liquid ready to use calibrator set for gentamicin. 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).
This document describes the VITROS Chemistry Products GENT Reagent, VITROS Chemistry Products Calibrator Kit 13, and VITROS Chemistry Products TDM Performance Verifiers I, II, and III used to quantitatively measure gentamicin (GENT) concentrations.
1. Table of Acceptance Criteria and Reported Device Performance
The device is considered substantially equivalent to the predicate device (SYVA® Emit® 2000 Gentamicin Plus Assay) based on the correlation and analytical performance studies. The primary acceptance criterion for the GENT assay is its strong correlation with the predicate device.
| Device Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Quantitative measurement of gentamicin | Quantitative measurement of gentamicin |
| Basic principle | Homogeneous enzyme immunoassay | Homogeneous enzyme immunoassay |
| Reportable Range | 0.25 - 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 | Not explicitly stated as a numerical AC, but implied strong correlation is required | Linear regression: VITROS GENT assay = 1.00 X - 0.0138 ug/mL, with a correlation coefficient of 0.993 (where X is the predicate device) |
2. Sample Size Used for the Test Set and Data Provenance
- The document states that "patient samples" were used for the equivalence study. However, the exact sample size of the test set is not specified.
- The data provenance (e.g., country of origin, retrospective or prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. For in-vitro diagnostic devices like this, the "ground truth" is typically established by comparative analysis with an established, legally marketed predicate device, or by reference methods, rather than expert consensus on patient images or clinical assessments.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluation involves comparing quantitative measurements from the new device against a predicate device, rather than expert adjudication of qualitative judgments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
- A MRMC comparative effectiveness study was not performed as this device is an in-vitro diagnostic assay, not an imaging device that would typically involve human readers interpreting results. The comparison is between the new assay and a predicate assay.
6. Standalone (Algorithm Only) Performance Study
- This description refers to the device's performance as a standalone assay. The study cited (correlation with predicate device, precision, expected values, linearity, and specificity studies) falls under this category of standalone analytical performance. The device is designed to operate autonomously with the VITROS 5,1 FS Chemistry System.
7. Type of Ground Truth Used
- The ground truth for the equivalence study was established by the measurements obtained from the predicate device (SYVA® Emit® 2000 Gentamicin Plus Assay) using the same "patient samples." Additionally, the product's instructions for use refer to studies on precision, expected values, linearity, and specificity, which would use established analytical methods or reference materials to determine ground truth.
8. Sample Size for the Training Set
- This document describes a 510(k) submission for an in-vitro diagnostic assay, not an AI/ML-driven device that typically requires a distinct "training set." Therefore, information regarding a specific training set size is not applicable and not provided. The development process for such assays involves internal studies (e.g., reagent optimization, calibration curve development) that are not typically referred to as "training sets" in the context of these submissions.
9. How Ground Truth for the Training Set Was Established
- As noted in point 8, the concept of a "training set" with ground truth in the AI/ML sense is not applicable to this type of device and submission. The analytical performance (e.g., linearity, precision) is established through rigorous laboratory experiments using reference materials and spiked samples with known concentrations, or comparison to established methods.
§ 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.