Wako Bilirubin Calibrator

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

510(k) Number

K993219 ↗

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 Bilirubin Calibrator in a clinical lab setting?

  The Wako Bilirubin Calibrator is designed to provide accurate reference standards for quantitative measurement of total and direct bilirubin levels in serum samples. It ensures reliable calibration of clinical chemistry assays, which is critical for diagnosing and monitoring conditions like jaundice, liver disease, or hemolytic anemia.

• Is the Wako Bilirubin Calibrator intended for single-use or repeated use, and what are its sterility specifications?

  The Wako Bilirubin Calibrator is explicitly labeled as a non-sterile, single-use reagent. Since it is intended for laboratory use as a calibrator, sterility is not required, but it must be handled in accordance with standard laboratory protocols to maintain reagent stability and accuracy.

• How should the Wako Bilirubin Calibrator be stored, and are there any special handling instructions?

  Storage follows standard laboratory practices for reagent stability, though specific conditions (e.g., temperature, light exposure) are not detailed in the provided data. Since it is non-sterile and single-use, it should be stored in a clean, dry environment away from contaminants until use, adhering to manufacturer guidelines for optimal performance.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?

  The Wako Bilirubin Calibrator received 510(k) clearance (K993219) under the Traditional 510(k) pathway, demonstrating substantial equivalence to a predicate device. The review was conducted by the Clinical Chemistry (CH) Advisory Committee, and it is classified as a Class II medical device under 21 CFR 862.1150 (Primary Calibrator).