PDJ — Hemoglobin A1c Test System Class II
FDA product code PDJ covers "Hemoglobin A1c Test System", a Class II medical device regulated under 21 CFR 862.1373. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PDJ
- Device Class
- Class II
- Regulation Number
- 862.1373
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252749 | shanghai medconn medical technology co | Medconn 8K Glycated Hemoglobin Test System | January 6, 2026 |
| K250073 | tosoh bioscience | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | October 3, 2025 |
| K242911 | shanghai medconn medical technology co | Medconn Glycated Hemoglobin Test system | June 20, 2025 |
| K220999 | shijiazhuang hipro biotechnology co | Hipro Glycosylated Hemoglobin (HbA1c) Test System | September 12, 2024 |
| K200904 | tosoh bioscience | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | August 5, 2021 |
| K200256 | siemens healthcare diagnostics | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | July 2, 2021 |
| K193053 | roche diagnostics operations (rdo) | Tina-quant Hemoglobin A1cDx Gen.3 | March 26, 2020 |
| K182651 | beckman coulter ireland | HbA1c Advanced | January 16, 2019 |
| K182988 | alere technologies | Afinion HbA1c Dx on Afinion 2 | November 29, 2018 |
| K173909 | siemens healthcare diagnostics | Dimension Hemoglobin A1c Assay | July 13, 2018 |
| K173206 | sekisui diagnostics p.e.i | SEKURE HbA1c Assay | July 12, 2018 |
| K180296 | alere technologies | Afinion HbA1c Dx | May 7, 2018 |
| K171861 | sebia | CAPILLARYS Hb A1c | February 7, 2018 |
| K171771 | siemens healthcare diagnostics | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | December 4, 2017 |
| K171537 | sebia | CAPI 3 Hb A1c | September 12, 2017 |
| K162822 | arkray factory | ADAMS A1c HA-8180V, CALIBRATOR 80 | June 29, 2017 |
| K160571 | roche diagnostics operations (rdo) | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | December 19, 2016 |
| K161687 | bio-rad laboratories | D-10 Hemoglobin A1c Program | October 14, 2016 |
| K151321 | bio-rad laboratories | D-100 HbA1c, D-100 HbA1c Calibrator Pack | December 9, 2015 |
| K142595 | ortho clinical diagnostics | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS C | June 4, 2015 |