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A-Gent Glycospec

by Abbott Laboratories 510(k)

Active United States

510(k) K791642

Overview

The A-Gent Glycospec is an assay device designed to measure glycosylated hemoglobin levels in blood samples. Glycosylated hemoglobin assays are used to monitor long-term blood glucose control in patients with diabetes, providing critical diagnostic information for managing the condition.

This device is intended for use in clinical laboratory settings and is classified as a Class II medical device under FDA regulations. Supplied as a single-use reagent system, it requires no sterilization beyond its original packaging. The A-Gent Glycospec operates under FDA-cleared authorization (510(k) K791642) and adheres to regulatory standards for hematology assays, ensuring reliable and accurate measurement of glycosylated hemoglobin.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK791642 Date17 Oct 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
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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Questions

  • What is the A-Gent Glycospec used for?

    The A-Gent Glycospec is a clinical assay device designed to measure glycosylated hemoglobin (HbA1c) levels in blood samples. HbA1c testing helps healthcare providers monitor long-term blood glucose control in patients with diabetes, providing critical data for managing the condition effectively. This measurement reflects average blood sugar levels over the past 2–3 months, aiding in treatment adjustments and disease progression assessment.

  • Where and how is the A-Gent Glycospec supplied?

    The A-Gent Glycospec is supplied as a single-use reagent system, meaning each kit is intended for one-time use only. It comes pre-packaged and requires no additional sterilization beyond its original packaging. This ensures consistency and reduces the risk of contamination in clinical laboratory settings.

  • Is the A-Gent Glycospec reusable or single-use?

    The A-Gent Glycospec is strictly a single-use device. Each reagent system is designed for one analysis, eliminating the need for cleaning, reprocessing, or sterilization between uses. This approach enhances accuracy, safety, and compliance with regulatory standards for hematology assays.

  • What regulatory pathway does the A-Gent Glycospec follow?

    The A-Gent Glycospec follows the FDA’s 510(k) clearance pathway, specifically under the Traditional 510(k) review process. It was granted clearance under the designation K791642 and is classified as a Class II medical device. This pathway ensures the device meets FDA standards for safety and effectiveness as a glycosylated hemoglobin assay.

  • How should the A-Gent Glycospec be stored?

    The A-Gent Glycospec should be stored according to the manufacturer’s instructions provided with the device. Typically, single-use reagent systems like this are stored in a clean, dry environment, protected from extreme temperatures and direct light. Always check the packaging for specific storage conditions, such as refrigeration or room temperature, to maintain the integrity and accuracy of the assay.