EMDS Lidocaine Calibrator Item No. 67XXX/95

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

510(k) Number

K881337 ↗

FDA Product Code

DLJ

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase Test

  Class I

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• Systemate Ldh, 67210

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  FDA 510(k) K843269 Active Cleared 13 Sep 1984

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• What is the primary purpose of the EMDS Lidocaine Calibrator Item No. 67XXX/95 in a clinical setting?

  The EMDS Lidocaine Calibrator Item No. 67XXX/95 is specifically designed to establish standardized reference points for measuring lidocaine concentrations in clinical toxicology testing systems. This ensures accuracy and consistency in analytical procedures, helping laboratories maintain reliable results when testing for lidocaine levels.

• Is the EMDS Lidocaine Calibrator meant for single-use or reusable applications?

  The device is explicitly supplied as a single-use item. It is not intended for reuse, which aligns with its classification as a Class II medical device under FDA 510(k) clearance for clinical toxicology applications.

• How is this calibrator regulated by the FDA, and what does that mean for its use?

  The EMDS Lidocaine Calibrator holds an FDA 510(k) clearance (K881337) under regulation 862.3200, classified as a Class II device. This means it has undergone a review process to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for use in clinical toxicology laboratories.

• Are there any special storage requirements for the EMDS Lidocaine Calibrator Item No. 67XXX/95?

  The provided data does not specify any unique storage requirements beyond standard handling for single-use calibrators. Since it is intended for clinical toxicology testing, it should be stored in a clean, controlled environment to preserve its integrity until use, following general laboratory protocols for calibration solutions.