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Hemoglobin Capillary Collection System (Hccs), 1 Test, Hemoglobin Capillary Collection System (Hccs), 5 Tests, Hemoglobi

by Bio-Rad Laboratories, Inc. 510(k)

Active United States

510(k) K090737

Overview

The Hemoglobin Capillary Collection System (HCCS) is a device designed for the collection of human whole blood for the determination of hemoglobin A1c using Bio-Rad HPLC methods. It combines collection, preparation, and transportation of capillary whole blood, providing a streamlined process for hemoglobin analysis.

The device is supplied as a single-use system and is intended for clinical use in the percentage determination of hemoglobin A1c. It is regulated under FDA 510(k) clearance and is manufactured by Bio-Rad Laboratories, Inc. The system is not reusable and requires proper storage conditions as specified by the manufacturer.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090737 Date3 Jun 2009ClearedStatusActive

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
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

From the manufacturer

The Hemoglobin Capillary Collection System combines collection, preparation, and transportation of capillary whole blood for the determination of hemoglobin A 1c.

Source: bio-rad.com

Other devices from Bio-Rad Laboratories, Inc.

See all devices from Bio-Rad Laboratories, Inc. →

Questions

  • What is the Hemoglobin Capillary Collection System (HCCS) used for?

    The HCCS is a single-use device designed for the collection of human whole blood from capillary sources. It is intended for the determination of hemoglobin A1c using Bio-Rad HPLC methods.

  • Is the HCCS system reusable?

    No, the Hemoglobin Capillary Collection System is supplied as a single-use system and is not intended for reuse. Proper disposal is required after use.

  • What are the storage requirements for the HCCS?

    The device requires proper storage conditions as specified by the manufacturer. It is important to follow these guidelines to maintain the integrity of the collection system.

  • How is the HCCS device supplied?

    The device is supplied as a single-use system. It is intended for clinical use in the percentage determination of hemoglobin A1c.