ACE Albumin Calibrator

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

510(k) Number

K821061 ↗

FDA Product Code

JIS

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from E.I. Dupont DE Nemours & Co., Inc. →

• What is the ACE Albumin Calibrator used for?

  The ACE Albumin Calibrator is a primary calibrator designed for quantitative measurement of albumin in biological samples, such as serum or plasma. It serves as a reference standard to maintain accuracy and consistency in laboratory assays, which is critical for diagnosing conditions related to protein levels.

• How is the ACE Albumin Calibrator supplied?

  The ACE Albumin Calibrator is supplied as a single-use device, meaning each unit is intended for one-time use in clinical chemistry laboratories. This ensures sterility and prevents cross-contamination between assays.

• Is the ACE Albumin Calibrator sterile?

  The device data does not specify whether the ACE Albumin Calibrator is sterile. Laboratories should follow standard protocols for handling single-use calibrators and ensure proper sterility practices when preparing for use.

• Can the ACE Albumin Calibrator be reused?

  No, the ACE Albumin Calibrator is explicitly designed for single-use only. Reusing it could compromise accuracy, consistency, and sterility, potentially leading to unreliable diagnostic results.

• What regulatory pathway was used for the ACE Albumin Calibrator?

  The ACE Albumin Calibrator was granted FDA 510(k) clearance (K821061) in 1982 through the Traditional 510(k) pathway. It is classified as a Class II medical device under FDA regulation 862.1150, indicating it poses a moderate risk and requires specific controls to ensure safety and effectiveness.