Glyco-Trol Human Glycosylated Hom. Cont.

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

510(k) Number

K802432 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the Glyco-Trol Human Glycosylated Hemoglobin Control used for?

  The Glyco-Trol Human Glycosylated Hemoglobin Control is designed for quantitative measurement of glycosylated hemoglobin (HbA1c) levels in blood samples. It serves as a reference standard to validate the accuracy and reliability of HbA1c assays, which are critical for monitoring diabetes management in clinical hematology settings. By providing a known concentration of glycosylated hemoglobin, it helps ensure that diagnostic tests produce consistent and trustworthy results.

• How is the Glyco-Trol Human Glycosylated Hemoglobin Control supplied?

  The Glyco-Trol is supplied as a ready-to-use control, meaning it is pre-prepared and does not require additional preparation steps before use in laboratory settings. This makes it convenient for immediate integration into HbA1c testing workflows, ensuring quick validation of assay performance.

• Is the Glyco-Trol Human Glycosylated Hemoglobin Control sterile?

  The provided data does not explicitly state whether the Glyco-Trol is sterile. However, as it is intended for in vitro diagnostic use in laboratory settings, it is reasonable to assume it would be manufactured and packaged under conditions that maintain sterility. For precise handling instructions, refer to the manufacturer’s labeling or documentation.

• Can the Glyco-Trol Human Glycosylated Hemoglobin Control be reused?

  The data does not specify whether the Glyco-Trol is single-use or reusable. Typically, assay controls like this are designed for single-use to ensure accuracy and prevent contamination. It is recommended to check the manufacturer’s instructions or packaging for clarification on usage guidelines.

• What regulatory pathway does the Glyco-Trol Human Glycosylated Hemoglobin Control follow?

  The Glyco-Trol Human Glycosylated Hemoglobin Control holds an FDA 510(k) clearance (K802432) and is classified as a Class II device under FDA regulations (21 CFR 864.7470). It was granted clearance through a traditional review pathway by the FDA’s Hematology Advisory Committee (HE). This classification and clearance indicate that it meets regulatory standards for use as an assay control in hematology.