FDA 510K for Bicarbonate Test System (Carbon Dioxide Test System)
A Bicarbonate/Carbon Dioxide (CO₂) Test System is used to measure the concentration of total carbon dioxide in a patient’s blood, which includes bicarbonate (HCO₃⁻), carbonic acid (H₂CO₃), and dissolved CO₂. This test is commonly performed as part of an electrolyte panel or comprehensive metabolic panel (CMP) to assess acid-base balance and metabolic status.
Intended Use of Bicarbonate/Carbon Dioxide Test System
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.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Carbon Dioxide Test System
FDA 510K for Carbon Dioxide Test System Device Code and Regulation Number
Ph Rate Measurement, Carbon-Dioxide
Intended Use
The Bicarbonate/Carbon Dioxide Test System is intended for use in the in vitro quantification of total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings. Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Device Description
The test cartridge is a single-use device that measures total carbon dioxide (TCO₂) in whole blood at the point of care or in a clinical lab. It requires 2-3 drops of blood, usually applied with a transfer device. The Analyzer is a handheld diagnostic device that works exclusively with i-STAT test cartridges. It moves fluid across sensors to provide a quantitative result in about 2 minutes. The System includes the analyzer, test cartridges, and accessories like a downloader/recharger, electronic simulator, and portable printer. It is for prescription use only and intended for trained medical professionals.
Enzymatic, Carbon-Dioxide
Intended Use
Carbon Dioxide Reagent Set is a device which is intended for measurement of Carbon Dioxide level in human serum, in vitro use only. Test results may provide information regarding the status in the assessment of acid-base balance of metabolic alkalosis or respiratory acidosis. This in vitro diagnostic device is intended for prescription use only.
Device Description
The Carbon Dioxide Reagent Set is a ready-to-use liquid kit designed for measuring total carbon dioxide (TCO₂) in a sample. It contains enzymes, buffers, stabilizers, and a preservative to support the reaction.
In the test, carbon dioxide reacts with phosphoenolpyruvate (PEP) and phosphoenolpyruvate carboxylase (PEPC), producing oxaloacetic acid (OAA). In the next step, malate dehydrogenase (MDH) converts OAA, causing a change in NADH absorbance at 405 nm. This change is measured spectrophotometrically and is directly proportional to the TCO₂ concentration in the sample.
Performance Testing (Analytical) for Carbon Dioxide Test System
- Precision/Reproducibility
- Linearity/assay reportable range
- Limit of Blank (LoB)
- Limit of Detection (LoD)
- Limit of Quantification (LoQ)
- Analytical Specificity/Interference
- Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
- Method comparison
Clinical Testing
No Guidance available for 510k submission