EMDS N-Acetylprocainamide Calibrator #67635/95

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

510(k) Number

K874101 ↗

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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• What is the primary purpose of the EMDS N-Acetylprocainamide Calibrator #67635/95 in a clinical setting?

  This calibrator is designed to standardize and verify the accuracy of analytical instruments that measure N-acetylprocainamide concentrations in biological samples. It ensures precise quantitative analysis, which is critical for monitoring procainamide toxicity or therapeutic drug levels in clinical toxicology settings.

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

  The EMDS N-Acetylprocainamide Calibrator #67635/95 is explicitly labeled as a single-use reagent, meaning it should not be reused after opening. This designation aligns with its role as a reference standard for one-time calibration or verification of analytical instruments.

• How is this device regulated, and what does its classification mean for buyers?

  The device holds an FDA 510(k) clearance (K874101) under 21 CFR 862.3200, classifying it as a Class II medical device with special controls for clinical toxicology applications. This means it has undergone regulatory review for safety and effectiveness, ensuring it meets established performance standards for calibrating procainamide measurements.

• Are there specific storage instructions provided for this calibrator?

  The provided regulatory data does not specify storage conditions or handling instructions for this calibrator. Buyers should consult the manufacturer’s labeling or instructions for proper storage (e.g., temperature, light exposure) to maintain its stability and accuracy before use.

• What types of laboratories would benefit most from using this calibrator?

  This calibrator is specifically designed for clinical toxicology laboratories that analyze N-acetylprocainamide levels in patient samples. It is particularly useful in settings where precise drug monitoring is required—such as hospitals, poison control centers, or specialized toxicology labs—to ensure accurate diagnostic results for procainamide-related cases.