Skip to content

Sodium and Potassium Standard

by Data Medical Associates, Inc. 510(k)

Active United States

510(k) K895717

Overview

The Sodium and Potassium Standard is a multi-analyte mixture calibrator used in clinical chemistry for the quantitative measurement of sodium and potassium levels. It serves as a reference material to ensure accuracy and consistency in in vitro diagnostic testing, particularly in automated clinical chemistry analyzers. By providing a standardized concentration of electrolytes, it aids in the calibration and validation of analytical systems, reducing variability in test results.

This device is supplied as a liquid calibrator for use in clinical laboratory settings. It is intended for single-use applications and does not require sterilization. The product is classified under FDA regulation 862.1150 and holds a 510(k) clearance (K895717) as a substantially equivalent device to predecessors. No MRI safety or reusable components are specified, and storage conditions are not detailed in the regulatory submission.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895717 Date11 Jan 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JIX
Device Class
Class II
Regulation
21 CFR Part 862.1150
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Data Medical Associates, Inc.

See all devices from Data Medical Associates, Inc. →

Questions

  • What is the Sodium and Potassium Standard used for in a clinical lab setting?

    The Sodium and Potassium Standard is a multi-analyte mixture calibrator designed to ensure accurate and consistent measurement of sodium and potassium levels in clinical chemistry testing. It serves as a reference material for calibrating and validating automated analyzers, helping to minimize variability in test results and maintain precision in electrolyte testing.

  • Is this device intended for single-use or repeated use?

    This device is explicitly intended for single-use applications. It is supplied as a liquid calibrator and does not require sterilization, making it suitable for one-time use in clinical laboratory settings to maintain accuracy and avoid cross-contamination.

  • How is the Sodium and Potassium Standard regulated by the FDA?

    The Sodium and Potassium Standard holds a 510(k) clearance (K895717) from the FDA, classified under regulation 862.1150. It was determined to be substantially equivalent to predecessor devices and was reviewed by the Clinical Chemistry (CH) Advisory Committee. The clearance was granted in 1990 following a traditional review process.

  • What types of analyzers is this calibrator compatible with?

    While the exact compatibility details are not specified in the regulatory data, this calibrator is designed for use in automated clinical chemistry analyzers that measure sodium and potassium levels. It is intended to standardize and validate these systems, ensuring reliable performance across a range of laboratory equipment used for electrolyte testing.