FDA product code PDJ: Hemoglobin A1c Test System
PDJ is the FDA product code for hemoglobin a1c test system. It is a Class II device, regulated under 21 CFR 862.1373 and reviewed by the Clinical Chemistry panel. FDA has cleared 25 510(k) submissions under PDJ, 4 in the last five years, from 14 different applicants. The average 510(k) review took 271 days (median 237); 430 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 9 recalls for PDJ devices, 7 initiated in the last five years.
Definition
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Classification
| Field | Value |
|---|---|
| Device name | Hemoglobin A1c Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.1373 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for PDJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 183 |
| 2018 | 5 | 168 |
| 2019 | 1 | 114 |
| 2020 | 1 | 146 |
| 2021 | 2 | 500 |
| 2024 | 1 | 892 |
| 2025 | 2 | 268 |
| 2026 | 1 | 130 |
Compare with all 510(k) review times · Search every PDJ clearance
Top PDJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tosoh Bioscience, Inc. | 3 | 2025-10-03 |
| Siemens Healthcare Diagnostics, Inc. | 3 | 2021-07-02 |
| Bio-Rad Laboratories, Inc. | 3 | 2016-10-14 |
| Shanghai Medconn Medical Technology Co., Ltd. | 2 | 2026-01-06 |
| Roche Diagnostics Operations (Rdo) | 2 | 2020-03-26 |
9 more applicants have PDJ clearances. See the full list in Caduvo.
Most recent PDJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252749 | Shanghai Medconn Medical Technology Co., Ltd. | Medconn 8K Glycated Hemoglobin Test System | 2026-01-06 | 130 |
| K250073 | Tosoh Bioscience, Inc. | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | 2025-10-03 | 266 |
| K242911 | Shanghai Medconn Medical Technology Co., Ltd. | Medconn Glycated Hemoglobin Test system | 2025-06-20 | 269 |
| K220999 | Shijiazhuang Hipro Biotechnology Co., Ltd. | Hipro Glycosylated Hemoglobin (HbA1c) Test System | 2024-09-12 | 892 |
| K200904 | Tosoh Bioscience, Inc. | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | 2021-08-05 | 486 |
Recalls for PDJ devices
9 product recalls in 7 recall events; 7 initiated in the last five years and 8 still open. Most recent: 2026-06-08.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 4 |
| 2023 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code PDJ?
PDJ is the FDA product code for hemoglobin a1c test system. It is a Class II device, regulated under 21 CFR 862.1373 and reviewed by the Clinical Chemistry panel.
What device class is PDJ?
Class II, regulation 21 CFR 862.1373. Typical premarket route: 510(k).
How long does a 510(k) take for product code PDJ?
Across 25 cleared submissions the average was 271 days from receipt to decision (median 237).
Which companies have the most PDJ clearances?
Tosoh Bioscience, Inc. (3); Siemens Healthcare Diagnostics, Inc. (3); Bio-Rad Laboratories, Inc. (3); Shanghai Medconn Medical Technology Co., Ltd. (2); Roche Diagnostics Operations (Rdo) (2).
Have PDJ devices been recalled?
Yes: 9 product recalls across 7 recall events; the most recent began 2026-06-08.
Next steps
- Run an FDA pathway report with predicate devices for product code PDJ
- Run a recall and safety report across every PDJ manufacturer
- Watch product code PDJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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