(225 days)
For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The VITROS ECO2 assay is performed using the VITROS Chemistry Products ECO2 Slides and the VITROS Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS ECO2 Slide is a multi-layered, analytical element coated on a polyester support. The method is based on an enzymatic detection. All reactions necessary for a single quantitative measurement of CO2 take place within the multi-layered analytical element of a VITROS Chemistry Products ECO2 Slide. A drop of sample fluid is metered onto the slide and a reaction occurs which ultimately results in a reduction of NADH. The concentration of CO2 in the sample is determined by measuring the absorbance of the unreacted NADH by reflectance spectrophotometry.
Here's a breakdown of the acceptance criteria and study details for the VITROS Chemistry Products ECO2 Slides, based on the provided 510(k) summary (K120763):
Device Overview:
This 510(k) submission is for a modified version of the VITROS Chemistry Products ECO2 Slides. The primary modification is a change in the biological source of Phosphoenolpyruvate carboxylase (PEPC) from wheat germ to a microorganism, aiming to improve enzyme solution stability during manufacturing. The device measures total carbon dioxide (CO2) concentration in serum and plasma using various VITROS Chemistry Systems.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly detailed as numerical ranges in the provided text, but rather described through the types of performance characteristics evaluated and the overarching conclusion that the modified device "met the pre-determined acceptance criteria for all the performance testing."
The performance characteristics considered for potential hazards and subsequently validated are:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy | Not explicitly stated (e.g., specific bias, error margin) | "met the pre-determined acceptance criteria" |
| Precision | Not explicitly stated (e.g., specific CV%) | "met the pre-determined acceptance criteria" |
| Linearity | Not explicitly stated (e.g., correlation coefficient) | "met the pre-determined acceptance criteria" |
| Potential Interferents | Not explicitly stated (e.g., no significant interference from common substances) | "met the pre-determined acceptance criteria" |
| Long Term Stability | Not explicitly stated (e.g., maintaining performance over specified shelf life) | "met the pre-determined acceptance criteria" |
| On-Analyzer Stability | Not explicitly stated (e.g., maintaining performance during use on the analyzer) | "met the pre-determined acceptance criteria" |
| Limit of Detection | Not explicitly stated (e.g., specific lower detection limit) | "met the pre-determined acceptance criteria" |
| Specimen Type | Valid performance for serum and plasma | "met the pre-determined acceptance criteria" |
Overall Conclusion regarding Acceptance Criteria: The document states, "Validation and verification testing were conducted and the modified device met the pre-determined acceptance criteria for all the performance testing. The modification does not negatively impact the performance of the device or the safety and effectiveness of the device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes used for the validation and verification testing (test set). It only states that "Validation and verification testing were conducted."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that this is a 510(k) summary for a diagnostic device, it is typically expected that studies would be conducted in a controlled laboratory setting, likely in the country of the manufacturer (USA, as inferred from the Rochester, NY address).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of medical device submission. This device is an in vitro diagnostic (IVD) chemistry product, not an imaging or AI-based diagnostic tool requiring expert interpretation of results. The "ground truth" for a CO2 measurement device is established through reference methods and calibrated instruments, not subjective expert consensus.
4. Adjudication Method for the Test Set
This is not applicable as it's an IVD chemistry product, not an imaging or qualitative diagnostic requiring adjudication of human interpretations. The "adjudication" is inherent in the analytical methods and instrument calibration.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered devices where human readers' performance with and without AI assistance is being evaluated. This 510(k) is for a modification to a chemistry diagnostic slide.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A (Not Applicable in the traditional sense of an "algorithm"). This is a chemical assay, not a standalone algorithm. The "performance" is the analytical performance of the device itself (slide and chemistry system) in measuring CO2 concentrations accurately and precisely. The studies conducted (accuracy, precision, linearity, etc.) assess the standalone analytical performance of the modified product.
7. The Type of Ground Truth Used
The ground truth for this device would be established through:
- Reference Methods: Highly accurate and precise analytical methods for CO2 measurement, often traceable to international standards.
- Calibrated Materials: Certified reference materials or calibrators with known CO2 concentrations.
- Comparison to Predicate Device: A key aspect of a Special 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. This implies that the performance of the modified device is compared against the established performance of the predicate.
The document states, "The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products ECO₂ Slides (modified)... is substantially equivalent to the predicate (unmodified VITROS ECO2 Slide) and is safe and effective for the stated intended use."
8. The Sample Size for the Training Set
This is not applicable to this type of device. The VITROS Chemistry Products ECO2 Slides utilize enzymatic reactions for detection, not a machine learning model that requires a "training set" in the computational sense. The "training" for such a product involves optimizing the chemical formulation and manufacturing process, which is distinct from data-driven AI model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as #8. The "ground truth" for developing this chemical assay would be based on fundamental chemistry principles, enzyme kinetics, and analytical performance characteristics measured through laboratory experiments, not a data-labeling process for a training set.
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.