Synchron System Hemoglobin Alc Reagent

• • Terminated Z-1156-04 FDA Unclassified (pre-2012) ·initiated 18 Aug 2003 ·on shared 510(k) K973696

  Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.

• • Terminated Z-1155-04 FDA Unclassified (pre-2012) ·initiated 15 Aug 2003 ·on shared 510(k) K973696

  LDL Cholesterol component in controls are unstable.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K973696 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Beckman Hdl Cholesterol Reagent

  Class I

  FDA 510(k) K934045 Active Cleared 14 Oct 1993

• Beckman Urine Protein Calibrator (Ucal)

  Class II

  FDA 510(k) K973928 Active Cleared 1 Dec 1997

• Beckman Uric Acid Reagent

  Class I

  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

See all devices from Beckman Instruments, Inc. →

• What is the Synchron System Hemoglobin A1c Reagent used for in a clinical setting?

  The Synchron System Hemoglobin A1c Reagent is designed to measure glycosylated hemoglobin (HbA1c) levels in human whole blood. HbA1c testing helps clinicians diagnose and monitor diabetes by quantifying the percentage of hemoglobin bound to glucose over time, providing insight into long-term blood sugar control.

• How is the Synchron System Hemoglobin A1c Reagent supplied, and is it intended for single-use or reuse?

  The reagent is supplied as a kit for processing whole blood samples, intended for use with the Synchron Clinical Systems. The data does not specify whether it is single-use or reusable, so its intended use should be confirmed with the manufacturer or local protocols.

• What regulatory pathway was followed for the FDA clearance of this device?

  The Synchron System Hemoglobin A1c Reagent received FDA clearance through a 510(k) submission, classified as a Traditional pathway. It was determined to be substantially equivalent to a predicate device under the Hematology advisory committee (HE) and falls under FDA classification 864.7470 for glycosylated hemoglobin assays.

• Are there multiple versions or models of this reagent, and how would I identify the correct one for my lab?

  The data lists multiple FEI numbers (e.g., 3043654757, 3003422726) associated with this reagent, which may correspond to different lot codes or configurations. To ensure compatibility, verify the exact FEI number or registration number on your kit against your lab’s inventory or consult Beckman Instruments for model-specific guidance.