Procainamide Calibrator Item No. 67634/95

No FDA recalls on record, checked 22 Oct 2026.

Full name

Emds Procainamide Calibrator Item No. 67634/95

510(k) Number

K874102 ↗

FDA Product Code

DLJ

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Em Diagnostic Systems, Inc. →

• What is the primary use of the EMDS Procainamide Calibrator Item No. 67634/95 in a clinical setting?

  The EMDS Procainamide Calibrator Item No. 67634/95 is specifically designed for clinical toxicology laboratories to provide standardized reference solutions for procainamide concentration measurements. It ensures accurate calibration of analytical instruments, which is critical for reliable diagnostic testing of procainamide levels in patient samples.

• Is this calibrator intended for single-use or repeated use in a laboratory?

  This calibrator is explicitly labeled as a single-use item. It is not designed for reuse, so each unit should be used once before disposal to maintain accuracy and prevent contamination.

• How is the EMDS Procainamide Calibrator supplied, and what should I consider regarding sterility?

  The calibrator is supplied as a non-sterile item, meaning it is not intended for direct patient contact or sterile procedures. It is meant solely for laboratory use in procainamide concentration calibration. Standard laboratory practices should be followed for handling to avoid contamination.

• What regulatory pathway was followed for this device’s approval, and what does that mean for its use?

  The EMDS Procainamide Calibrator received a Traditional 510(k) clearance under FDA product code DLJ, classified as a Class II device. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for clinical toxicology calibrators. The clearance confirms its compliance with FDA requirements for drug-specific calibrators.

• Are there specific storage instructions provided for this calibrator, or should I rely on general laboratory practices?

  The provided data does not specify unique storage instructions for this calibrator. However, it is recommended to follow standard laboratory practices for storage to maintain its integrity, such as keeping it in a clean, dry environment away from direct sunlight or extreme temperatures until use.