ACA Alcohol Calibrators

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

510(k) Number

K771799 ↗

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 E.I. Dupont DE Nemours & Co., Inc. →

• What is the ACA Alcohol Calibrator used for in clinical settings?

  The ACA Alcohol Calibrator is specifically designed for clinical toxicology to ensure the accuracy and reliability of alcohol measurement in biological samples. It helps maintain precise calibration of alcohol testing equipment, which is critical for diagnosing alcohol levels in patients and ensuring compliance with regulatory standards for toxicology assessments.

• Are the ACA Alcohol Calibrators single-use or reusable?

  The ACA Alcohol Calibrators are supplied as single-use items. This design choice helps prevent cross-contamination and ensures consistent performance for each calibration procedure, which is essential in clinical toxicology where accuracy is paramount.

• What regulatory approval does the ACA Alcohol Calibrator hold?

  The ACA Alcohol Calibrator is regulated under FDA 510(k) clearance with the clearance number K771799. It is classified as a Class II device under product code DLJ and 21 CFR 862.3200, indicating it has been deemed substantially equivalent to a predicate device through the traditional clearance process.

• How are the ACA Alcohol Calibrators stored?

  While specific storage instructions are not detailed in the provided data, single-use calibrators like the ACA Alcohol Calibrators are typically stored in a clean, dry environment protected from extreme temperatures and direct light. Proper storage ensures the integrity of the calibrator until use, maintaining its accuracy for clinical toxicology applications.

• What clinical specialty does the ACA Alcohol Calibrator support?

  The ACA Alcohol Calibrator is intended for use in clinical toxicology, a specialty focused on the diagnosis and treatment of poisoning and other exposure to toxic substances. Its precise calibration aids in ensuring reliable alcohol level measurements, which are vital for accurate toxicology assessments.