Hemoglobin A1c Test System
The Hemoglobin A1c Test System is a clinical chemistry in vitro diagnostic device used for the quantitative determination of Hemoglobin A1c (HbA1c) to aid in the diagnosis of diabetes and to monitor long-term glycemic control in diabetic patients. It falls under the Clinical Chemistry medical specialty and is classified as a Class 2 device under regulation 862.1373, requiring 510(k) premarket notification. HbA1c measurement reflects average blood glucose levels over the preceding two to three months. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- PDJ
- Device Class
- FDA class 2
- Regulation Number
- 862.1373
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 24 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242911 | Medconn Glycated Hemoglobin Test system | Jun 20, 2025 | Substantially Equivalent | Shanghai Medconn Medical Technology Co.,Ltd. |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Sep 12, 2024 | Substantially Equivalent | Shijiazhuang Hipro Biotechnology Co., Ltd. |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | Aug 05, 2021 | Substantially Equivalent | Tosoh Bioscience, Inc. |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Jul 02, 2021 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | Mar 26, 2020 | Substantially Equivalent | Roche Diagnostics Operations (RDO) |
| K182651 | HbA1c Advanced | Jan 16, 2019 | Substantially Equivalent | Beckman Coulter Ireland Inc. |
| K182988 | Afinion HbA1c Dx on Afinion 2 | Nov 29, 2018 | Substantially Equivalent | Alere Technologies AS |
| K173909 | Dimension Hemoglobin A1c Assay | Jul 13, 2018 | Substantially Equivalent | Siemens Healthcare Diagnostics Inc. |
| K173206 | SEKURE HbA1c Assay | Jul 12, 2018 | Substantially Equivalent | Sekisui Diagnostics PEI Inc. |
| K180296 | Afinion HbA1c Dx | May 07, 2018 | Substantially Equivalent | Alere Technologies AS |
| K171861 | CAPILLARYS Hb A1c | Feb 07, 2018 | Substantially Equivalent | Sebia |
| K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Dec 04, 2017 | Substantially Equivalent | Siemens Healthcare Diagnostics Inc. |
| K171537 | CAPI 3 Hb A1c | Sep 12, 2017 | Substantially Equivalent | Sebia |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | Jun 29, 2017 | Substantially Equivalent | Arkray Factory, Inc. |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | Dec 19, 2016 | Substantially Equivalent | Roche Diagnostics Operations (RDO) |
| K161687 | D-10 Hemoglobin A1c Program | Oct 14, 2016 | Substantially Equivalent | BIO-RAD LABORATORIES, INC. |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Dec 09, 2015 | Substantially Equivalent | Bio-Rad Laboratories, Inc. |
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II | Jun 04, 2015 | Substantially Equivalent | ORTHO CLINICAL DIAGNOSTICS |
| K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | May 22, 2015 | Substantially Equivalent | ABBOTT LABORATORIES |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | Mar 24, 2015 | Substantially Equivalent | Bio-Rad Laboratories, Inc. |
| K130255 | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS | Feb 28, 2014 | Substantially Equivalent | ABBOTT LABORATORIES |
| K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 | Jan 23, 2014 | Substantially Equivalent | Tosoh BioScience, Inc. |
| K121610 | COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY | Aug 08, 2013 | Substantially Equivalent | ROCHE DIAGNOSTICS OPERATIONS |
| DEN130002 | TINA-QUANT HBA1C GEN. 2 TEST SYSTEM | May 23, 2013 | Unknown | Roche Diagnostics |
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.