Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LCP · Predicate Candidate Screening
249 FDA 510(k) clearances under this product code; the 50 most recent screened below.
100 daysmedian FDA review time
319 days90th percentile
249clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024-11-22 | 931 | 0 |
| K231465 | Q-Pad Test System | Qurasense | 2023-12-06 | 201 | 0 |
| K214117 | Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer | Abbott Diagnostics Technologies AS | 2023-09-27 | 636 | 0 |
| K192987 | Aina HbA1c Monitoring System 2 | Jana Care, Inc. | 2020-03-26 | 153 | 0 |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A | Ixensor Co, Ltd. | 2019-10-29 | 60 | 0 |
| K183230 | OneDraw A1C Test System | Drawbridge Health, Inc. | 2019-08-15 | 268 | 0 |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A | Ixensor Co, Ltd. | 2019-04-12 | 269 | 0 |
| K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | 2019-02-16 | 354 | 0 |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla | Skyla Corporation H.S.P.B | 2018-09-25 | 361 | 0 |
| K170623 | ACE Hemoglobin A1c (HbA1c) Reagent | Alfa Wassermann Diagnostic Technologies, LLC | 2018-02-27 | 363 | 0 |
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | 2017-11-21 | 169 | 2 |
| K170147 | Lucica Glycated Albumin-L | Asahi Kasei Pharma Corporation | 2017-10-12 | 268 | 0 |
| K163633 | cobas HbA1c Test, cobas b 101 system | Roche Diagnostics Operations | 2017-07-28 | 218 | 0 |
| K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | 2017-06-16 | 379 | 0 |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | Sebia | 2017-02-17 | 186 | 0 |
| K160762 | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diaz | Diazyme Laboratories | 2016-11-21 | 245 | 0 |
| K142664 | URight Hemoglobin A1c system, FORA A1c System | Taidoc Technology Corporation | 2016-01-29 | 498 | 0 |
| K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c | Sd Biosensor, Inc. | 2015-09-30 | 547 | 0 |
| K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | 2015-09-25 | 85 | 0 |
| K141944 | HOME ACCESS AIC TEST | Home Access Health Corp. | 2015-03-13 | 239 | 0 |
| K142789 | A1c iGear System | Sakae Corporation | 2014-12-16 | 81 | 0 |
| K133803 | DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT | Diazyme Laboratories | 2014-08-06 | 233 | 0 |
| K141750 | HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM | Infopia Co, Ltd. | 2014-07-24 | 24 | 0 |
| K140829 | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT | Beckman Coulter, Inc. | 2014-07-14 | 104 | 0 |
| K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | Bio-Rad Laboratories, Inc. | 2014-06-25 | 86 | 0 |
| K130014 | A1C GEAR SYSTEM | Sakae Corporation | 2014-04-04 | 457 | 0 |
| K133344 | MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CON | Sebia | 2014-03-28 | 149 | 0 |
| K131307 | ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSA | Siemens Healthcare Diagnostics, Inc. | 2014-01-24 | 262 | 4 |
| K130990 | VARIANT(TM) II TURBO HBA1C KIT - 2.0 | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013-05-09 | 29 | 0 |
| K130860 | VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOB | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013-04-25 | 28 | 0 |
| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | Axis-Shield Diagnostics, Ltd. | 2012-12-12 | 170 | 0 |
| K122101 | CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPIL | Sebia | 2012-12-06 | 143 | 0 |
| K122472 | VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN T | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2012-10-26 | 73 | 0 |
| K120199 | GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY | Beckman Coulter, Inc. | 2012-10-12 | 263 | 0 |
| K111128 | LABONACHECK A1C | Ceragem International, Inc. | 2012-09-13 | 511 | 0 |
| K121492 | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT | Beckman Coulter, Inc. | 2012-09-11 | 113 | 0 |
| K121366 | HEMOCUE HBA1C 501 | Infopia Co, Ltd. | 2012-09-07 | 123 | 0 |
| K113437 | ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGEN | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-06 | 259 | 0 |
| K120497 | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MAT | Medica Corp. | 2012-05-14 | 83 | 0 |
| K110313 | TINA-QUANT HBA1C GEN.2 | Roche Diagnostics | 2011-12-23 | 324 | 0 |
| K112015 | PREMIER HB9210 HBA1C ANALYZER | Primus Corporation Dba Trinity Biotech | 2011-11-22 | 132 | 0 |
| K110934 | ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATM | Siemens Healthcare Diagnostics | 2011-08-25 | 143 | 1 |
| K093548 | AVIE A1C TEST SYSTEM | Mec Dynamics Corp | 2011-07-20 | 610 | 0 |
| K100547 | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYST | Seppim S.A.S. | 2011-05-19 | 448 | 0 |
| K110188 | DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONT | Diazyme Laboratories | 2011-05-17 | 113 | 0 |
| K102510 | DIMENSIONS HB1C KIT, MODEL DF105A | Siemens Healthcare Diagnostics | 2011-05-13 | 259 | 1 |
| K110056 | AFINION ANALYZER | Axis-Shield Poc AS | 2011-02-15 | 36 | 0 |
| K102045 | DIMENSION VISA HBA1C, MODEL K3105A | Siemens Heatlhcare Diagnostics, Inc. | 2011-02-14 | 208 | 3 |
| K102914 | TQ HBA1C GEN3 | Roche | 2011-01-20 | 111 | 0 |
| K100304 | ST AIA PACK HBA1C | Tosoh Bioscience, Inc. | 2010-08-27 | 205 | 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