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HemoCue HBA1C 501

by Infopia Co, Ltd.

510(k) K121366

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK121366 Date7 Sep 2012ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The HemoCue HbA1c 501 is an automated boronate affinity assay system for measuring HbA1c percentage in human whole blood. It is a fully automated point-of-care system that provides reliable results within 5 minutes. System components include an analyzer, test cartridges, check cartridges, thermal printer, and barcode scanner.

The HemoCue HbA1c 501 is intended for point-of-care testing of HbA1c. It is supplied as a system with various components and is authorized under FDA 510(k) clearance with product code LCP. The device is designed for use in clinical settings where immediate results are needed for patient follow-up.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the HemoCue HbA1c 501 system used for?

    The HemoCue HbA1c 501 is an automated boronate affinity assay system designed for point-of-care testing of HbA1c percentage in human whole blood. It provides reliable results within 5 minutes, making it suitable for clinical settings where immediate results are needed for patient follow-up.

  • What components are included in the HemoCue HbA1c 501 system?

    The HemoCue HbA1c 501 system includes an analyzer, test cartridges, check cartridges, thermal printer, and barcode scanner. These components work together to provide a fully automated point-of-care testing solution for HbA1c measurement.

  • Is the HemoCue HbA1c 501 system cleared for regulatory use?

    The HemoCue HbA1c 501 is authorized under FDA 510(k) clearance with product code LCP. It received FDA clearance on September 7, 2012, and is classified as a Class II device for the assay of glycosylated hemoglobin.

  • How is the HemoCue HbA1c 501 system supplied?

    The HemoCue HbA1c 501 is supplied as a complete system with various components including the analyzer, test cartridges, check cartridges, thermal printer, and barcode scanner. It is designed for use in clinical settings where immediate HbA1c results are needed for patient management.