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LabonaCheck A1C

by Ceragem International, Inc. 510(k)

Active United States

510(k) K111128

Overview

The LabonaCheck A1C is an assay device for glycosylated hemoglobin, designed to quantitatively measure hemoglobin A1c levels in venous whole blood and capillary fingerstick samples. It falls under the category of hematology diagnostic tools, providing a numerical percentage of glycated hemoglobin to assess long-term blood glucose control.

This device is intended for multiple patient, professional use and is supplied as a reusable system with a touch-screen LCD interface, automatic tray feeding, and optional connectivity via RS-232, USB, or Ethernet. It includes a thermal printer and built-in battery with an external power source option. The LabonaCheck A1C has received FDA 510(k) clearance under product code LCP, classified as a Class 2 Chemistry device.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111128 Date13 Sep 2012ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, 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

Other devices from Ceragem International, Inc.

Questions

  • What is the LabonaCheck A1C used for?

    The LabonaCheck A1C is designed to quantitatively measure glycosylated hemoglobin (hemoglobin A1c) levels in venous whole blood and capillary fingerstick samples. It provides a numerical percentage of glycated hemoglobin, which helps assess long-term blood glucose control in patients. This is particularly useful for monitoring diabetes management.

  • How is the LabonaCheck A1C supplied and what does it include?

    The LabonaCheck A1C is supplied as a reusable system intended for multiple patient, professional use. It includes a touch-screen LCD interface, automatic tray feeding for sample processing, a thermal printer for result documentation, and connectivity options via RS-232, USB, or Ethernet. Additionally, it features a built-in battery with the option for external power sourcing.

  • Is the LabonaCheck A1C single-use or reusable?

    The LabonaCheck A1C is a reusable device, meaning it is designed for repeated use in professional settings after proper cleaning, maintenance, and sterilization procedures. This makes it cost-effective for laboratories and clinics performing frequent A1C testing.

  • What connectivity options does the LabonaCheck A1C offer?

    The LabonaCheck A1C supports multiple connectivity options, including RS-232, USB, and Ethernet. These interfaces allow for data transfer to computers or other systems, enabling integration with laboratory information management systems (LIMS) or electronic health records (EHR). This enhances workflow efficiency and data accessibility.

  • What regulatory clearance does the LabonaCheck A1C have?

    The LabonaCheck A1C has received FDA 510(k) clearance under product code LCP, classified as a Class 2 Chemistry device. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for safety and effectiveness in its intended use.