Synchron Systems Cholesterol (Chol) Reagent

• • Ongoing Z-0399-2022 FDA Class II ·initiated 10 Nov 2021

  Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.

510(k) Number

K971505 ↗

FDA Product Code

CHH

Device Class

Class I

Regulation

21 CFR Part 862.1175

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Beckman Hdl Cholesterol Reagent

  Class I

  FDA 510(k) K934045 Active Cleared 14 Oct 1993

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  Class II

  FDA 510(k) K973928 Active Cleared 1 Dec 1997

• Beckman Uric Acid Reagent

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  FDA 510(k) K821812 Active Cleared 2 Jul 1982

• Immage Immunochemistry System Alpha-2-Macroglobulin Reagent

  Class II

  FDA 510(k) K974564 Active Cleared 17 Feb 1998

• Immage Immunochemistry System Ceruloplasmin (Cer) Reagent

  Class II

  FDA 510(k) K964762 Active Cleared 25 Apr 1997

• Immage Immunochemistry System Haptoglobin (Hpt) Reagent

  Class II

  FDA 510(k) K963286 Active Cleared 7 Oct 1996

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