Total Bilirubin Procedure Run On A AU5000 Instru

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

510(k) Number

K880396 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Hemoglobin Controls

  Class II

  FDA 510(k) K790457 Active Cleared 4 Apr 1979

• Gamma Glutamyl Transferase Procedure

  Class I

  FDA 510(k) K863586 Active Cleared 3 Oct 1986

• Direct Bilirubin Procedure

  Class II

  FDA 510(k) K881166 Active Cleared 28 Apr 1988

• Data-Zyme Glucose Hexokinase UV

  Class II

  FDA 510(k) K801052 Active Cleared 23 May 1980

• Data-Zyme Triglyceride Procedure

  Class I

  FDA 510(k) K780379 Active Cleared 12 May 1978

• Magnesium Procedure

  Class I

  FDA 510(k) K861668 Active Cleared 27 May 1986

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• What is the Total Bilirubin Procedure used for?

  The Total Bilirubin Procedure is a clinical chemistry test system that measures total bilirubin levels in patient samples using diazo colorimetry, providing quantitative results for diagnostic purposes in clinical laboratory settings.

• How is the Total Bilirubin Procedure supplied and used?

  The procedure is supplied as part of the AU5000 instrument system and is designed to be run specifically on the AU5000 instrument for measuring bilirubin in patient samples.

• Is the Total Bilirubin Procedure single-use or reusable?

  The device data does not specify whether the Total Bilirubin Procedure is single-use or reusable, so no determination can be made about its reusability from the provided information.

• What regulatory pathway was used for the Total Bilirubin Procedure?

  The device received FDA 510(k) clearance with K number K880396 on March 15, 1988, and is substantially equivalent to predicate devices, indicating it followed the traditional 510(k) pathway.