Roche Standards for Chloride & CO2

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K850396 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Roche Diagnostic Systems, Inc. →

• What is the Roche Standards for Chloride & CO₂ used for?

  This device is a multi-analyte calibrator designed to provide standardized reference values for chloride and carbon dioxide (CO₂) measurements in clinical chemistry. It ensures accuracy and consistency when calibrating analytical instruments used for quantitative analysis in serum, plasma, or urine samples. By maintaining precise standards, it helps laboratories deliver reliable test results critical for patient diagnosis and monitoring.

• How is the Roche Standards for Chloride & CO₂ supplied and intended for use?

  The standards are supplied as a liquid reagent, formulated specifically for single-use applications in clinical chemistry laboratories. Each vial is intended for one calibration procedure, ensuring sterility and consistency per use. This design minimizes contamination risk and reduces the need for complex storage or handling protocols beyond standard laboratory practices.

• Are the Roche Standards for Chloride & CO₂ sterile and single-use?

  Yes, the Roche Standards for Chloride & CO₂ are formulated as a single-use liquid reagent, which inherently supports sterility for clinical applications. The liquid form is sealed to prevent microbial contamination, and its intended use as a calibrator means it is not reused. This aligns with best practices for maintaining precision and safety in laboratory testing.

• What storage conditions are required to maintain the integrity of the Roche Standards for Chloride & CO₂?

  The product requires proper storage to preserve stability and integrity before use. While specific storage conditions (e.g., temperature, light exposure) are not detailed in the provided data, most liquid calibrators like this are typically stored refrigerated (2–8°C) and protected from light. Always refer to the product labeling or manufacturer guidelines for exact instructions, as deviations may compromise accuracy or shelf life.

• What distinguishes this calibrator from other multi-analyte standards?

  This calibrator is uniquely identified by the product code JIX and is FDA 510(k)-cleared (K850396) as substantially equivalent to a predicate device for chloride and CO₂ measurements. Its formulation targets quantitative analysis in serum, plasma, or urine, making it suitable for clinical chemistry laboratories requiring precise calibration. The liquid format and single-use design further differentiate it from reusable or multi-component systems.