ION 2 Reagent KI

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

510(k) Number

K851350 ↗

FDA Product Code

CEM

Device Class

Class II

Regulation

21 CFR Part 862.1600

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Hi Chem, Inc. →

• What is the ION 2 Reagent KI used for?

  The ION 2 Reagent KI is designed for quantitative measurement of potassium ions in clinical chemistry. It supports diagnostic and monitoring procedures by providing accurate serum or plasma potassium level assessments in laboratory settings. This is particularly useful for evaluating electrolyte balance, cardiac function, and renal health.

• How is the ION 2 Reagent KI supplied and intended for use?

  The ION 2 Reagent KI is supplied as a reagent kit and is intended for single-use only. It is compatible with automated or semi-automated clinical chemistry analyzers, ensuring precise and reliable potassium ion measurements in a clinical lab environment.

• What storage conditions are required for the ION 2 Reagent KI?

  The ION 2 Reagent KI does not require special storage conditions beyond standard laboratory practices. However, it must be stored to maintain sterility and integrity until use. This means keeping it in a clean, dry environment, protected from contamination and extreme temperatures.

• Is the ION 2 Reagent KI reusable, or is it meant for single-use?

  The ION 2 Reagent KI is explicitly designed for single-use only. This ensures accuracy and reliability in potassium ion measurements, as reuse could compromise sterility and introduce variability in results. Always follow the manufacturer’s instructions to avoid cross-contamination.

• What regulatory clearance does the ION 2 Reagent KI hold?

  The ION 2 Reagent KI holds an FDA 510(k) clearance under the Clinical Chemistry advisory committee. It is classified as a Class II device under Special Controls (regulation number 862.1600), indicating it has been evaluated and deemed substantially equivalent to a predicate device for its intended use.