Alko Calibrators and Flush Solution for IL 1300 Series pH/Blood Gas Analyzers

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K945966 ↗

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 the Alko Calibrators and Flush Solution for IL 1300 Series pH/blood gas analyzers?

  This solution is designed to ensure the accuracy and reliability of IL 1300 Series pH/blood gas analyzers by providing standardized mixtures for calibration. It helps maintain precise measurements of pH, blood gases, and related analytes in clinical chemistry applications, ensuring consistent performance in laboratory settings.

• How is the Alko Calibrators and Flush Solution supplied, and is it intended for single-use?

  The solution is supplied as a ready-to-use liquid for flushing and calibrating the analyzers. While the data does not explicitly state whether it is single-use or reusable, it is intended for use in regulated clinical chemistry environments where precision is critical, suggesting it is likely designed for single-use to maintain sterility and accuracy.

• What regulatory pathway was followed for the FDA clearance of this device?

  The Alko Calibrators and Flush Solution received FDA clearance through a 510(k) submission (K945966) under the Traditional clearance type, determined to be Substantially Equivalent (SESE) to a predicate device. The review was conducted by the Clinical Chemistry (CH) advisory committee, and the device is classified as a Class II medical device.

• Are there multiple versions or models of this calibrator solution, and if so, how are they differentiated?

  The provided data lists multiple FEI numbers (e.g., 3002808140, 3006198300), which may correspond to different lot codes, batch numbers, or specific calibrator formulations tailored for various IL 1300 Series analyzer models or calibration needs. However, the exact differentiation between models is not detailed in the provided information.

• What type of storage or handling instructions should be followed for this calibrator solution?

  While specific storage conditions (e.g., temperature, light exposure) are not detailed in the data, as a regulated clinical chemistry solution, it should be stored according to standard laboratory protocols for liquid calibrators—typically in a cool, dry place, away from direct sunlight, and protected from contamination. Always refer to the manufacturer’s labeling or accompanying documentation for precise instructions.