Modified Sodium Electrode

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

510(k) Number

K863907 ↗

FDA Product Code

JGS

Device Class

Class II

Regulation

21 CFR Part 862.1665

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Electrolyte Analyzer

  Class II

  FDA 510(k) K851808 Active Cleared 25 Jun 1985

• Calcium and Ph Electrolyte Analyzer

  Class II

  FDA 510(k) K895397 Active Cleared 12 Dec 1989

• Model 400/450 Electrolyte Analyzer

  Class II

  FDA 510(k) K932179 Active Cleared 17 Nov 1993

• Miniature Ion Selective Electrodes

  Class II

  FDA 510(k) K802856 Active Cleared 28 Jan 1981

• Potassium and Sodium Electrolyte Analyzer

  Class II

  FDA 510(k) K890792 Active Cleared 3 May 1989

• Miniature Ion Selective Electrodes

  Class I

  FDA 510(k) K830130 Active Cleared 7 Mar 1983

• What is the primary clinical use of the Modified Sodium Electrode, and where is it typically deployed?

  The Modified Sodium Electrode is designed specifically to measure sodium ion concentration in blood or other biological specimens, making it essential for precise electrolyte monitoring in clinical chemistry applications. It is intended for use exclusively in clinical laboratory settings, where accurate sodium level analysis is critical for patient diagnostics and treatment planning.

• Is the Modified Sodium Electrode intended for single-use or repeated use, and what does this mean for its handling?

  The device is explicitly labeled for single-use only, meaning each electrode is intended to be discarded after one use. This design minimizes the risk of cross-contamination and ensures consistent, reliable measurements. Laboratories must adhere to this guideline to maintain accuracy and comply with safety protocols.

• How is the Modified Sodium Electrode regulated, and what does this imply for purchasing or using it in a clinical setting?

  The device received FDA 510(k) clearance under product code JGS, classifying it as a Class 2 medical device governed by regulation 21 CFR 862.1665. This means it must meet FDA compliance standards for design, manufacturing, and labeling, but it does not require sterile packaging or special handling beyond standard clinical laboratory procedures. Purchasers should verify that their supplier adheres to these regulatory requirements.

• Are there different sizes or models of the Modified Sodium Electrode, and if so, how might they vary in application?

  The provided data does not specify distinct sizes or models beyond the core design as an ion-specific sodium electrode. However, the registration numbers and FEI numbers suggest multiple lot or batch variations may exist for manufacturing consistency. Clinicians should confirm with the manufacturer or supplier if specific model differences (e.g., electrode tip design or compatibility with analyzers) are relevant to their workflow.

• What storage conditions should be followed for the Modified Sodium Electrode to ensure its integrity and performance?

  While the data does not explicitly detail storage requirements, as a non-sterile, single-use electrode, it should be stored in a clean, dry environment protected from extreme temperatures, humidity, and direct light. Laboratories should follow the manufacturer’s instructions (available via Ionetics, Inc.) for optimal shelf life and to prevent degradation of the electrode’s sensitivity. Standard Class 2 device storage practices typically apply.