Prealbumin Calibrator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K982292 ↗

FDA Product Code

JIT

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 Dade Behring, Inc. →

• What clinical chemistry systems is the Prealbumin Calibrator designed to work with, and is it reusable or single-use?

  The Prealbumin Calibrator is specifically designed for use with the Dimension® clinical chemistry system. It is supplied as a single-use reagent, meaning each vial is intended for one calibration procedure to ensure accuracy and prevent cross-contamination.

• How is the Prealbumin Calibrator classified under FDA regulations, and what does this mean for its use?

  The Prealbumin Calibrator is classified as a Class II device under 21 CFR 862.1150, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness. This classification means it undergoes FDA 510(k) clearance (K982292) to demonstrate substantial equivalence to a predicate device before commercial distribution.

• Is the Prealbumin Calibrator intended for in vitro diagnostic use, and where would it typically be used?

  Yes, the Prealbumin Calibrator is intended exclusively for in vitro diagnostic use in laboratory settings. It standardizes prealbumin (PALB) measurements on automated clinical chemistry systems, ensuring consistent and accurate diagnostic results for clinicians assessing nutritional status, liver function, or inflammatory conditions.

• Are there multiple sizes or models of the Prealbumin Calibrator, or is it supplied in a single formulation?

  The provided data does not specify multiple sizes or models for the Prealbumin Calibrator. It is described as a single-use reagent without variations in formulation or packaging, ensuring uniformity for calibration purposes on the Dimension® system.