Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PDJ — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
237 daysmedian FDA review time
486 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | 2026-01-06 | 130 | 0 |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. | 2025-10-03 | 266 | 0 |
| K242911 | Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. | 2025-06-20 | 269 | 0 |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024-09-12 | 892 | 0 |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | Tosoh Bioscience, Inc. | 2021-08-05 | 486 | 0 |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-02 | 515 | 2 |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics Operations (Rdo) | 2020-03-26 | 146 | 0 |
| K182651 | HbA1c Advanced | Beckman Coulter Ireland, Inc. | 2019-01-16 | 114 | 0 |
| K182988 | Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS | 2018-11-29 | 31 | 0 |
| K173909 | Dimension Hemoglobin A1c Assay | Siemens Healthcare Diagnostics, Inc. | 2018-07-13 | 203 | 0 |
| K173206 | SEKURE HbA1c Assay | Sekisui Diagnostics P.E.I., Inc. | 2018-07-12 | 283 | 0 |
| K180296 | Afinion HbA1c Dx | Alere Technologies AS | 2018-05-07 | 94 | 0 |
| K171861 | CAPILLARYS Hb A1c | Sebia | 2018-02-07 | 230 | 0 |
| K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2017-12-04 | 173 | 0 |
| K171537 | CAPI 3 Hb A1c | Sebia | 2017-09-12 | 110 | 0 |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | Arkray Factory, Inc. | 2017-06-29 | 265 | 0 |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assa | Roche Diagnostics Operations (Rdo) | 2016-12-19 | 294 | 0 |
| K161687 | D-10 Hemoglobin A1c Program | Bio-Rad Laboratories, Inc. | 2016-10-14 | 119 | 0 |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories, Inc. | 2015-12-09 | 205 | 0 |
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibra | Ortho Clinical Diagnostics | 2015-06-04 | 262 | 1 |
| K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin | Abbott Laboratories | 2015-05-22 | 434 | 0 |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | Bio-Rad Laboratories, Inc. | 2015-03-24 | 203 | 0 |
| K130255 | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C C | Abbott Laboratories | 2014-02-28 | 392 | 1 |
| K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 | Tosoh Bioscience, Inc. | 2014-01-23 | 237 | 0 |
| K121610 | COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY | Roche Diagnostics Operations | 2013-08-08 | 433 | 0 |
| DEN130002 | TINA-QUANT HBA1C GEN. 2 TEST SYSTEM | Roche Diagnostics | 2013-05-23 | 59 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda