Wako HDL-C/LDL-C Calibrator

• • Terminated Z-0932-2021 FDA Class III ·initiated 22 Dec 2020

  FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing.

510(k) Number

K001005 ↗

FDA Product Code

JIS

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Wako Direct Bilirubin V

  Class II

  FDA 510(k) K970986 Active Cleared 7 May 1997

• Wako Autokit CH50

  Class II

  FDA 510(k) K954145 Active Cleared 18 Dec 1995

• Wako Total Bilirubin V

  Class II

  FDA 510(k) K970985 Active Cleared 21 Apr 1997

• Wako Nefa Linearity Set

  Class I

  FDA 510(k) K030065 Active Cleared 11 Feb 2003

• Total Bilirubin Standard Calibrator

  Class II

  FDA 510(k) K872263 Active Cleared 22 Jul 1987

• Wako Autokit Apo A1

  Class I

  FDA 510(k) K952615 Active Cleared 8 Sep 1995

See all devices from Wako Chemicals USA, Inc. →

• What is the primary purpose of the Wako HDL-C/LDL-C Calibrator in a clinical lab setting?

  The Wako HDL-C/LDL-C Calibrator is designed to provide accurate reference standards for quantitative measurement of high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) in serum samples. It ensures reliable calibration of automated clinical chemistry analyzers, which is critical for maintaining the precision of lipid profile testing results.

• How is the Wako HDL-C/LDL-C Calibrator supplied, and is it intended for single-use or repeated use?

  The calibrator is supplied as a liquid reagent, specifically formulated for single-use in laboratory environments. This design aligns with standard clinical chemistry protocols to prevent contamination and ensure consistency in assay performance.

• Does this calibrator require any special handling or storage conditions beyond typical laboratory practices?

  The device does not specify any unique storage or handling requirements beyond standard clinical chemistry protocols. It is intended for use in laboratory settings where typical conditions for liquid reagents—such as temperature control and protection from light—are already in place.

• What regulatory pathway was followed for the FDA clearance of this calibrator, and what class does it belong to?

  The Wako HDL-C/LDL-C Calibrator received Special 510(k) clearance (K001005) under the FDA’s Class II device classification. This clearance was granted as substantially equivalent to a predicate device, confirming its compliance with clinical chemistry standards for primary calibrators.

• Is this calibrator compatible with any specific brands or types of clinical chemistry analyzers?

  The device is explicitly intended for use with Wako’s HDL-C assay reagents, though compatibility with other analyzers would depend on their ability to accommodate primary calibrators for HDL-C/LDL-C measurement. Always verify analyzer compatibility with the manufacturer’s instructions.