(60 days)
- For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
- For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of vancomycin (VANC).
- For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assaved control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and VANC on VITROS Chemistry Systems.
The VITROS Chemistry Products VANC Reagent, VITROS Chemistry Products Calibrator Kit 11, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS VANC assay. VITROS Chemistry Products VANC Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure vancomycin.
VITROS Chemistry Products Calibrator Kit 11 and TDM Performance Verifiers are packaged and sold separately.
VITROS Chemistry Products Calibrator Kit 11 is a liquid ready to use calibrator set for vancomycin. 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 liguid 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 an analysis of the provided 510(k) summary regarding the VITROS Chemistry Products VANC assay and controls:
1. Acceptance Criteria and Reported Device Performance
The submission uses substantial equivalence to a predicate device as its basis for clearance, rather than defining explicit acceptance criteria with pre-specified thresholds for performance metrics. The primary "acceptance criteria" here are implied by the performance of the predicate device and the demonstration of equivalent performance for the new device.
| Metric / Characteristic | Acceptance Criteria (Implied by Predicate) | Reported VITROS VANC Assay Performance |
|---|---|---|
| Intended Use | Quantitative measurement of vancomycin | Quantitative measurement of vancomycin |
| Basic Principle | Homogeneous enzyme immunoassay | Homogeneous enzyme immunoassay |
| Reportable Range | 5.0 - 50 µg/mL | 5.0 - 50 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 to Predicate | Not explicitly stated, but high correlation expected | Correlation Coefficient: 0.996 (vs. SYVA Emit 2000 Vancomycin Assay) |
| Linear Regression: VITROS VANC assay = 1.00 X + 0.00 µg/mL (where X is the predicate device) | ||
| Precision | Performance comparable to predicate | Studies performed, details not provided in summary |
| Expected Values | Performance comparable to predicate | Studies performed, details not provided in summary |
| Linearity | Performance comparable to predicate | Studies performed, details not provided in summary |
| Specificity | Performance comparable to predicate | Studies performed, details not provided in summary |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary mentions "patient samples" were used for correlation studies but does not specify the sample size for the test set used to compare the VITROS VANC assay against the predicate device.
The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective), but it's implied to be retrospective as patient samples were used for correlation against an existing, cleared assay.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as the device is an in vitro diagnostic (IVD) assay for quantitative measurement. Ground truth for quantitative diagnostic assays typically refers to a reference method or a predicate device comparison rather than expert adjudication of images or clinical assessments.
4. Adjudication Method for the Test Set
This information is not applicable for this type of IVD assay. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., imaging studies) where human experts determine ground truth. For a quantitative assay, the comparison is against an established reference method or predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted and is not applicable for this device. This type of study involves human readers interpreting cases with and without AI assistance, which is irrelevant for a standalone quantitative IVD assay.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The entire evaluation described is a standalone performance study, as it assesses the algorithm (the VITROS VANC assay) directly against a predicate device and other performance characteristics (precision, linearity, specificity) without human-in-the-loop interpretation. The performance metrics reported (correlation coefficient, linear regression) are direct measures of the assay's agreement with the predicate.
7. Type of Ground Truth Used
The ground truth for the comparison was established using a predicate device (SYVA Emit 2000 Vancomycin Assay) and patient samples. This means the new device's measurements were compared against the measurements obtained from an already FDA-cleared, commercially available assay using the same patient samples.
8. Sample Size for the Training Set
The document does not provide information regarding a specific "training set" sample size. For an IVD assay, the development process might involve numerous samples for calibration development and optimization, but these are typically not referred to as a distinct "training set" in the same way as machine learning models. The correlation and performance studies act as the validation.
9. How the Ground Truth for the Training Set Was Established
Since a specific "training set" and its ground truth establishment mechanism are not detailed in the provided summary, this information is not available. However, for a chemical assay, the "ground truth" during development (analogous to training) would involve:
- Using known concentration standards to develop calibration curves.
- Testing against reference materials with established vancomycin concentrations.
- Optimization of reagent formulations to achieve desired analytical performance.
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.