Document Ammonia, Ethanol, Lactate Calibrator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K962629 ↗

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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• What is the primary purpose of this calibrator in a clinical chemistry lab?

  This calibrator is designed to provide standardized reference values for ammonia, ethanol, and lactate measurements. It ensures accurate calibration of automated, semi-automated, or manual clinical chemistry analyzers, helping maintain precision in laboratory testing for these key analytes.

• Is this calibrator intended for single-use or repeated use, and why?

  The calibrator is explicitly intended for single-use only. Since it is supplied as an aqueous liquid without any indication of sterilization or reprocessing compatibility, repeated use could compromise accuracy or introduce contamination risks, which is why it is not designed for reuse.

• Does this calibrator require special storage conditions beyond standard laboratory practices?

  No, the calibrator does not require any special storage conditions beyond those recommended by the manufacturer. The documentation does not mention refrigeration, temperature controls, or other unique requirements, so standard laboratory storage practices should suffice.

• How is this calibrator regulated, and what does that mean for its use?

  The calibrator is authorized under FDA 510(k) clearance (K962629), meaning it has been deemed *substantially equivalent* to a legally marketed device and meets regulatory standards for in vitro diagnostic devices under classification II. This clearance confirms its compliance with safety and performance requirements for clinical chemistry calibration, ensuring it can be legally used in U.S. laboratories.

• What types of clinical chemistry analyzers can this calibrator be used with?

  This calibrator is compatible with automated, semi-automated, or manual clinical chemistry analyzers, as specified in its description. Its multi-analyte design ensures it can standardize measurements for ammonia, ethanol, and lactate across a range of systems commonly used in laboratory settings.