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VITROS Chemistry Products CO2 DT Slides quantitatively measure carbon dioxide (CO2) concentration in serum and plasma using VITROS DT60 and DT60 II Chemistry Systems. Total carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance. For in vitro diagnostic use only.

The VITROS Chemistry Products CO2 DT Slide assay is performed using the VITROS Chemistry Products CO2DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/DT60 II Chemistry Systems. The VITROS CO2 DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of jonic carbon dioxide. All reactions necessary for a single quantitative measurement of carbon dioxide take place within the multi-layered analytical element of a VITROS Chemistry Products CO2 DT Slide. The slide consists of two ion-selective electrodes, each containing a buffer layer, an ion-selective membrane layer, a reference layer, and silver and a silver chloride layer coated on a polvester support.

VITROS Chemistry Products CO2 DT Slides use ion-selective electrodes for potentiometric measurements of ionic carbon dioxide. Ionic carbon dioxide determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products CO2 DT Slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode, which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge. The carbon dioxide ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establishes equilibrium.

After an incubation period, the electrometer in the VITROS Chemistry System measures the potential difference between the reference and indicator electrodes. Each electrode responds to the activity of carbon dioxide ions in the respective fluids to produce a potential for the concentration cell. The VITROS DT60/DT60II Chemistry System's microprocessor uses this measurement and the stored calibration parameters to determine the concentration value of the carbon dioxide ion in the sample fluid. The test result is reported in millimoles per liter (mmol/ L).

VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added.

The VITROS DT60/ DT60 II Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

The provided text is a 510(k) summary for the VITROS Chemistry Products CO2 DT Slides. It details the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to complete the requested table and answer all questions regarding acceptance criteria, study details, and performance metrics.

Specifically, the document states: "The information presented in the premarket notification demonstrates that the performance of the VITROS Chemistry Products CO2 DT Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device. Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured carbon dioxide values spanning the assay range."

This indicates that a study was performed to show equivalence, but it does not provide:

• A table of acceptance criteria and reported device performance values (e.g., accuracy, precision, bias).
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone algorithm performance study.
• The type of ground truth used (e.g., pathology, clinical outcomes).
• The sample size for the training set.
• How ground truth for the training set was established.

Therefore, I cannot fulfill the request for a detailed description of the acceptance criteria and the study that proves the device meets them based on the provided text. The information is simply not present in this 510(k) summary.

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