Assay, Glycosylated Hemoglobin
FDA product code LCP · Class II (moderate risk) · 21 CFR 864.7470 · Hematology
249510(k) clearances
0PMA approvals
99recalls
Manufacturers
- Helena Laboratories 19
- Bio-Rad 15
- Primus Corp. 9
- Bio-Rad Laboratories, Inc. 8
- Isolab, Inc. 7
- Metrika, Inc. 7
- Abbott Laboratories 7
- Beckman Coulter Inc. 5
- Roche Diagnostics Corp. 5
- Diazyme Laboratories 5
- Pointe Scientific, Inc., 4
- Pierce Chemical Co. 4
- Roche Diagnostic Systems, Inc. 4
- Sandare Chemical Co., Inc. 4
- Heraeus Kulzer, Inc. 4
- Provalis Diagnostics , Ltd. 3
- Mec Dynamics Corp 3
- Beckman Instruments, Inc. 3
- Boehringer Mannheim Corp. 3
- Alfa Wassermann Diagnostic Technologies, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP · Dual Track | Nova Biomedical Corporation | 11/22/2024SE |
| K231465 | Q-Pad Test SystemLCP · Traditional | Qurasense | 12/06/2023SE |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 AnalyzerLCP · Dual Track | Abbott Diagnostics Technologies AS | 09/27/2023SE |
| K192987 | Aina HbA1c Monitoring System 2LCP · Traditional | Jana Care, Inc. | 03/26/2020SE |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 10/29/2019SE |
| K183230 | OneDraw A1C Test SystemLCP · Traditional | Drawbridge Health, Inc. | 08/15/2019SE |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 04/12/2019SE |
| K180509 | Quo-Test A1c SystemLCP · Dual Track | Ekf-Diagnostic GmbH | 02/16/2019SE |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…LCP · Traditional | Skyla Corporation H.S.P.B | 09/25/2018SE |
| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 02/27/2018SE |
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzerLCP · Special | Abbott Rapid Diagnostics | 11/21/2017SE |
| K170147 | Lucica Glycated Albumin-LLCP · Traditional | Asahi Kasei Pharma Corporation | 10/12/2017SE |
| K163633 | cobas HbA1c Test, cobas b 101 systemLCP · Traditional | Roche Diagnostics Operations | 07/28/2017SE |
| K161533 | A1C EZ Glycohemoglobin Analysis SystemLCP · Traditional | Biohermes Co., Ltd. | 06/16/2017SE |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)LCP · Traditional | Sebia | 02/17/2017SE |
| K160762 | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay…LCP · Traditional | Diazyme Laboratories | 11/21/2016SE |
| K142664 | URight Hemoglobin A1c system, FORA A1c SystemLCP · Traditional | Taidoc Technology Corporation | 01/29/2016SE |
| K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetLCP · Traditional | Sd Biosensor, Inc. | 09/30/2015SE |
| K151809 | Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerLCP · Special | Alere Technologies AS | 09/25/2015SE |
| K141944 | Home Access Aic TestLCP · Traditional | Home Access Health Corp. | 03/13/2015SE |
| K142789 | A1c iGear SystemLCP · Traditional | Sakae Corporation | 12/16/2014SE |
| K133803 | Diazyme Glycated Serum Protein Poc Test KitLCP · Traditional | Diazyme Laboratories | 08/06/2014SE |
| K141750 | Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemLCP · Special | Infopia Co, Ltd. | 07/24/2014SE |
| K140829 | Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) ReagentLCP · Traditional | Beckman Coulter, Inc. | 07/14/2014SE |
| K140801 | Variant II Turbo Link Hemoglobin A1C Program/Testing SystemLCP · Special | Bio-Rad Laboratories, Inc. | 06/25/2014SE |
| K130014 | A1C Gear SystemLCP · Traditional | Sakae Corporation | 04/04/2014SE |
| K133344 | Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys…LCP · Traditional | Sebia | 03/28/2014SE |
| K131307 | Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine CalibratorLCP · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/24/2014SE |
| K130990 | Variant(Tm) II Turbo HBA1C Kit - 2.0LCP · Special | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 05/09/2013SE |
| K130860 | Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…LCP · Special | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 04/25/2013SE |
| K121842 | Architect HBA1C, Architect HBA1C, and Architect HBA1CLCP · Traditional | Axis-Shield Diagnostics, Ltd. | 12/12/2012SE |
| K122101 | Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls…LCP · Traditional | Sebia | 12/06/2012SE |
| K122472 | Variant II Turbo HBA1C KIT-2.0 Variant II Turbo Hemoglobin Testing SystemLCP · Traditional | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 10/26/2012SE |
| K120199 | Glycosylated Hemoglobin Assay; Clinical ChemistryLCP · Traditional | Beckman Coulter, Inc. | 10/12/2012SE |
| K111128 | Labonacheck A1CLCP · Traditional | Ceragem International, Inc. | 09/13/2012SE |
| K121492 | Unicel DXC Synchron Systems Hemoglobin ALC-(HBA1C-) ReagentLCP · Special | Beckman Coulter, Inc. | 09/11/2012SE |
| K121366 | Hemocue HBA1C 501LCP · Special | Infopia Co, Ltd. | 09/07/2012SE |
| K113437 | Ace Hemoglobin Alc(Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…LCP · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 08/06/2012SE |
| K120497 | Easyra Hbalc Regent Easycal HBLC Calibrator Easyqc Hbalc MaterialLCP · Traditional | Medica Corp. | 05/14/2012SE |
| K110313 | Tina-Quant HBA1C GEN.2LCP · Traditional | Roche Diagnostics | 12/23/2011SE |
| K112015 | Premier HB9210 HBA1C AnalyzerLCP · Traditional | Primus Corporation Dba Trinity Biotech | 11/22/2011SE |
| K110934 | Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment AssayLCP · Traditional | Siemens Healthcare Diagnostics | 08/25/2011SE |
| K093548 | Avie A1C Test SystemLCP · Traditional | Mec Dynamics Corp | 07/20/2011SE |
| K100547 | Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C Calibrator Set…LCP · Traditional | Seppim S.A.S. | 05/19/2011SE |
| K110188 | Diazyme Glycated Serum Protein Assay / Calibrator Kit / Control KitLCP · Special | Diazyme Laboratories | 05/17/2011SE |
| K102510 | Dimensions HB1C Kit, Model DF105ALCP · Traditional | Siemens Healthcare Diagnostics | 05/13/2011SE |
| K110056 | Afinion AnalyzerLCP · Traditional | Axis-Shield Poc AS | 02/15/2011SE |
| K102045 | Dimension Visa HBA1C, Model K3105ALCP · Traditional | Siemens Heatlhcare Diagnostics, Inc. | 02/14/2011SE |
| K102914 | TQ HBA1C GEN3LCP · Special | Roche | 01/20/2011SE |
| K100304 | ST Aia Pack HBA1CLCP · Traditional | Tosoh Bioscience, Inc. | 08/27/2010SE |
| K082275 | Clover A1C/GLYCOSYLATED Hemoglobin Monitor & Blood Glucose Monitor, Model IGM-0023LCP · Traditional | Infopia Co, Ltd. | 01/14/2010SE |
| K091711 | S- Test Hemoglobin Alc (HBA1C), Model RC0023LCP · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 12/11/2009SE |
| K090699 | Variant II Turbo HBA1C Kit KIT-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730LCP · Traditional | Bio-Rad Laboratories, Inc. | 07/27/2009SE |
| K091400 | Modification to Avie A1C Test SystemLCP · Special | Mec Dynamics Corp | 06/11/2009SE |
| K090413 | A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional…LCP · Special | Bayer Healthcare, LLC | 05/14/2009SE |
| K081269 | Avie A1C Test SystemLCP · Traditional | Mec Dynamics Corp | 03/20/2009SE |
| K081895 | Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsLCP · Traditional | Siemens Medical Solutions Diagnostics | 01/08/2009SE |
| K073309 | Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis ReagentLCP · Traditional | Horiba Abx | 10/17/2008SE |
| K071132 | G8 Automated HPLC Analyzer, Model HLC-723 G8LCP · Traditional | Tosoh Bioscience, Inc. | 09/16/2008SE |
| K080618 | Direct HBA1C, Fructosamine, Glucose Oxidase LiquidLCP · Traditional | Jas Diagnostics, Inc. | 05/23/2008SE |
| K072714 | Tina-Quant Hemoglobin A1C GEN.2 Test SystemLCP · Special | Roche Diagnostics Corp. | 04/18/2008SE |
| K072686 | Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C ControlsLCP · Traditional | Axis-Shield Diagnostics, Ltd. | 03/17/2008SE |
| K062658 | Primus A1CARE AssayLCP · Traditional | Primus Corp. | 11/26/2007SE |
| K071466 | Dca Vantage, Model 5075LCP · Special | Siemens Medical Solutions Diagnostics | 10/09/2007SE |
| K070819 | Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin…LCP · Traditional | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 06/25/2007SE |
| K070452 | Variant II Hemoglobin A1C Program with Models 270-2101NULCP · Traditional | Bio-Rad Laboratories, Inc. | 05/07/2007SE |
| K063306 | Ace Hemoglobin A1C Reagent, Model ACI-21, Hemoglobin A1C Calibrators, Model S2-72…LCP · Traditional | Alfa Wassermann, Inc. | 04/17/2007SE |
| K070734 | Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A, DZ168A-CAL, DZ168A-CONLCP · Special | Diazyme Laboratories | 04/09/2007SE |
| K063209 | HBA1C; Calibrator; Control Normal, Control AbnormalLCP · Traditional | Thermo Electron OY | 03/21/2007SE |
| K063643 | Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and…LCP · Special | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 12/27/2006SE |
| K063400 | Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0LCP · Special | Bio-Rad Laboratories, Inc. | 12/01/2006SE |
| K060650 | Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products…LCP · Special | Ortho-Clinical Diagnostics, Inc. | 04/06/2006SE |
| K053411 | Dri Hemoglobin A1C Assay and CalibratorsLCP · Traditional | Microgenics Corp. | 02/03/2006SE |
| K060001 | D-10 Hemoglobin A1C Program; D-10 Dual ProgramLCP · Special | Bio-Rad Laboratories, Inc. | 01/20/2006SE |
| K052464 | Tina-Quant Hemoglobin A1C GEN.2 TestLCP · Special | Roche Diagnostics Corp. | 09/30/2005SE |
| K051200 | Hemoglobin A1C Reagent SetLCP · Traditional | Teco Diagnostics | 08/08/2005SE |
| K050574 | Afinion HbalcLCP · Traditional | Axis-Shield Poc AS | 07/22/2005SE |
| K050178 | HBA1C Enzymatic AssayLCP · Traditional | General Atomics | 06/28/2005SE |
| K051321 | InviewLCP · Special | Metrika, Inc. | 06/13/2005SE |
| K042459 | Synchron LX Systems Hemoglobin A1C2 (HBA1C2) ReagentLCP · Traditional | Beckman Coulter, Inc. | 11/17/2004SE |
| K042193 | Diazyme Glycated Serum Protein Enzymatic Assay KitLCP · Traditional | Diazyme Laboratories | 10/29/2004SE |
| K031296 | Liqui-Heme Glyco A1C AssayLCP · Traditional | Biodiagnostic Intl | 10/15/2004SE |
| K041764 | The Vitros 5,1 FS Chemistry SystemLCP · Traditional | Ortho-Clinical Diagnostics | 09/09/2004SE |
| K041635 | G5 I HBA1C Test, G5 II HBA1C TestLCP · Traditional | Provalis Diagnostics , Ltd. | 08/16/2004SE |
| K041444 | Bio-Rad D-10 Dual ProgramLCP · Traditional | Bio-Rad Laboratories, Inc. | 06/09/2004SE |
| K040872 | Variant II Hemoglobin A1CLCP · Traditional | Bio-Rad Laboratories, Inc. | 04/15/2004SE |
| K033674 | Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C ControlsLCP · Traditional | Seradyn, Inc. | 02/09/2004SE |
| K033847 | A1CNOW for Home and Professional UseLCP · Special | Metrika, Inc. | 12/23/2003SE |
| K031380 | Olympus HBA1C Reagent, (Catalog Number OSR6192), Olympus HBA1C Calibrator, (Catolog…LCP · Traditional | Olympus America, Inc. | 11/14/2003SE |
| K031042 | Atac Hemoglobin A1C Reagent KitLCP · Traditional | Clinical Data, Inc. | 11/03/2003SE |
| K030553 | Arkit HBA1CLCP · Traditional | Arkray, Inc. | 09/02/2003SE |
| K031043 | D-10 Hemoglobin A1CLCP · Traditional | Bio-Rad Laboratories, Inc. | 08/27/2003SE |
| K031539 | Hemoglobin A1C Reagent SetLCP · Traditional | Pointe Scientific, Inc., | 08/06/2003SE |
| K023654 | Glyca-Direct FructosamineLCP · Traditional | Polymedco, Inc. | 05/02/2003SE |
| K023763 | Randox Fructosamine, Fructosamine Calibrator, Fructosamine ControlsLCP · Traditional | Randox Laboratories, Ltd. | 01/13/2003SE |
| K022661 | A1CNOW for Home UseLCP · Traditional | Metrika, Inc. | 12/13/2002SE |
| K021897 | Randox Haemoglobin A1CLCP · Traditional | Randox Laboratories, Ltd. | 11/26/2002SE |
| K021484 | Hemoglobin A1C ControlLCP · Traditional | Canterbury Scientific , Ltd. | 06/14/2002SE |
| K020532 | Polymedco HBA1C TestLCP · Traditional | Polymedco, Inc. | 04/24/2002SE |
| K020235 | A1CNOW for Professional UseLCP · Special | Metrika, Inc. | 02/15/2002SE |
| K020234 | A1CNOW for RX Home UseLCP · Special | Metrika, Inc. | 02/15/2002SE |
| K013465 | Accu-Base Hemoglobin A1C Sample Collection KitLCP · Traditional | Diabetes Technologies, Inc. | 01/22/2002SE |
| K011852 | Dimension Haic Assay, Model DF105LCP · Traditional | Dade Behring, Inc. | 11/15/2001SE |
| K011933 | Glycosal II Hba 1C TestLCP · Traditional | Provalis Diagnostics , Ltd. | 11/02/2001SE |
| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | Sigma Diagnostics, Inc. | 10/26/2001SE |
| K012525 | Thermo Dma Fructosamine Assay, Model 7500-135/235LCP · Abbreviated | Thermo Dma, Inc. | 10/04/2001SE |
| K011434 | G7 Automated HPLC AnalyzerLCP · Traditional | Tosoh Medics, Inc. | 09/18/2001SE |
| K010748 | Synchron Systems Hemoglobin A1C ReagentLCP · Traditional | Beckman Coulter, Inc. | 07/10/2001SE |
| K003280 | Variant II Total GHBLCP · Traditional | Bio-Rad | 12/19/2000SE |
| K003120 | Modification to Integra Reagent Cassette for Hemoglobin A1CLCP · Traditional | Roche Diagnostics Corp. | 12/18/2000SE |
| K000885 | DRX HBA1C - for Prescription Home UseLCP · Traditional | Metrika, Inc. | 09/26/2000SE |
| K001392 | Glycosal HBA1C TestLCP · Traditional | Provalis Diagnostics , Ltd. | 08/21/2000SE |
| K000887 | DRX HBA1CLCP · Traditional | Metrika, Inc. | 07/26/2000SE |
| K992085 | Abbott Imx Glycated Hemoglobin IILCP · Traditional | Abbott Laboratories | 05/25/2000SE |
| K993131 | Nycocard HBA1C Glycosylated Hemoglobin AssayLCP · Traditional | Primus, Inc. | 05/22/2000SE |
| K000239 | Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High ControlLCP · Traditional | Genzyme Corp. | 03/21/2000SE |
| K994045 | Primus Liquid Calibrator for GHB/A1C Level 1 and Level 2LCP · Special | Primus Corp. | 12/21/1999SE |
| K993590 | Fructosamine Reagent Set, Calibrator, and Control SetLCP · Traditional | Pointe Scientific, Inc., | 12/21/1999SE |
| K990899 | HEMOCHEK-A1C Sample Collection KitLCP · Traditional | Osborn Group, Inc. | 12/21/1999SE |
| K991246 | Fructosamine, Model FR 106-01LCP · Traditional | A.P. Total Care, Inc. | 12/16/1999SE |
| K991850 | Safe At-Home Test Kit for Monitoring Hemoglobin AlcLCP · Traditional | Biosafe Laboratories, Inc. | 11/26/1999SE |
| K992921 | Primus Liquid Control for Ghb/Alc Level I and Level IILCP · Traditional | Primus Corp. | 11/12/1999SE |
| K991483 | Abbott Architect Glycated HemoglobinLCP · Traditional | Abbott Laboratories | 11/01/1999SE |
| K990992 | Integra Reagent Cassette for Hemoglobin AlcLCP · Traditional | Roche Diagnostics Corp. | 09/30/1999SE |
| K984529 | Hemochek Sample Collection KitLCP · Traditional | Osborn Laboratories, Inc. | 01/28/1999SE |
| K984268 | Variant II Hemoglobin A1C ProgramLCP · Traditional | Bio-Rad | 12/17/1998SE |
| K983172 | Accu-Base Hemoglobin A1C Sample Collection KitLCP · Traditional | Diabetes Technologies, Inc. (Dti) | 11/30/1998SE |
| K983726 | Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High ControlLCP · Traditional | Genzyme Corp. | 11/25/1998SE |
| K983253 | Precision A1C Home HBA1C Sample Collection KitLCP · Traditional | Medisense, Inc. | 11/20/1998SE |
| K980888 | GlycacorLCP · Traditional | Exocell, Inc. | 08/13/1998SE |
| K973365 | Aic - Chek (Hbaic-I)LCP · Traditional | Express-Med, Inc. | 06/15/1998SE |
| K974491 | Accu-Chek A1C Hemoglobin TestLCP · Traditional | Boehringer Mannheim Corp. | 05/13/1998SE |
| K973696 | Synchron System Hemoglobin Alc ReagentLCP · Traditional | Beckman Instruments, Inc. | 11/24/1997SE |
| K972265 | A1C 2.2 Plus - Automated Glycohemoglobin AnalyzerLCP · Traditional | Tosoh Medics, Inc. | 09/25/1997SE |
| K971919 | Ezchek/Hba Blood Collection KitLCP · Traditional | Flexsite Diagnostics, Inc. | 09/05/1997SE |
| K962597 | LXN Fructosamine Test SystemLCP · Traditional | Lxn Corp. | 06/13/1997SE |
| K963844 | Hydragel 15 HB A1C KitLCP · Traditional | Morax | 04/22/1997SE |
| K961674 | Roche Unimate Fructosamine ReagentLCP · Traditional | Roche Diagnostic Systems, Inc. | 09/27/1996SE |
| K955087 | Hemoglobin Alc (HBA1C) & Total Assays for the Technicon Ra/Opera Systems In-Vitro…LCP · Traditional | Bayer Corp. | 06/13/1996SE |
| K952337 | Roche Unimate 3/UNIMATE 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & PLCP · Traditional | Roche Diagnostic Systems, Inc. | 02/09/1996SE |
| K946274 | Columnmate II GHB Affinity Regenerable ColumnLCP · Traditional | Helena Laboratories | 07/11/1995SE |
| K936285 | Abbott Vision Glycated HB, ModificationLCP · Traditional | Abbott Laboratories | 06/09/1995SE |
| K951361 | Dca 2000 System for Hemoglobin A1CLCP · Traditional | Heraeus Kulzer, Inc. | 05/05/1995SE |
| K941616 | Variant Total GHB ProgramLCP · Traditional | Bio-Rad | 04/14/1995SE |
| K934070 | Tina-Quant Hemoglobin A1CLCP · Traditional | Boehringer Mannheim Corp. | 10/11/1994SE |
| K942009 | Primus Rapid Gel 100 Glycated Hemoglobin AssayLCP · Traditional | Primus Corp. | 09/14/1994SE |
| K940971 | Ames Dca 2000 Hemoglobin Alc ControlsLCP · Traditional | Heraeus Kulzer, Inc. | 07/19/1994SE |
| K935613 | Radias Monoclonal Hba 1C AssayLCP · Traditional | Bio-Rad | 04/05/1994SE |
| K936204 | Glycated Hemoglobin CalibratorsLCP · Traditional | Primus Corp. | 03/22/1994SE |
| K940143 | Glycated Hemoglobin ControlsLCP · Traditional | Primus Corp. | 03/15/1994SE |
| K931183 | GlycohemoglobinLCP · Traditional | Teco Diagnostics | 11/05/1993SE |
| K933287 | 745 GlycomatLCP · Traditional | Drew Scientific , Ltd. | 09/09/1993SE |
| K930823 | Protein-Bound Glucose Assayn KitLCP · Traditional | Diagnostic Specialties | 08/19/1993SE |
| K926469 | Variant(Tm) Hemoglobin a 1C ProgramLCP · Traditional | Bio-Rad | 03/29/1993SE |
| K925204 | Beckman Diatrac Hemoglob A1C Electro Kit, ModifiedLCP · Traditional | Beckman Instruments, Inc. | 01/12/1993SE |
| K921831 | Imx(R) Glycated HemoglobinLCP · Traditional | Abbott Laboratories | 09/29/1992SE |
| K920820 | Modification ColumnmateLCP · Traditional | Helena Laboratories | 08/17/1992SE |
| K920397 | Reflab System Pack Liquid Fructosamine ReagentLCP · Traditional | Medical Analysis Systems, Inc. | 08/04/1992SE |
| K920449 | Pointe 750 GlycometerLCP · Traditional | Pointe Scientific, Inc., | 07/28/1992SE |
| K920198 | Glycomat Haemoglobin AnalyserLCP · Traditional | Drew Scientific , Ltd. | 07/21/1992SE |
| K921676 | Columnmate IILCP · Traditional | Helena Laboratories | 07/10/1992SE |
| K921305 | Glyco-Tek Affinity Column KitLCP · Traditional | Helena Laboratories | 06/09/1992SE |
| K913614 | Fructosamine ABG21 Test SystemLCP · Traditional | Boehringer Mannheim Corp. | 12/02/1991SE |
| K912748 | Binax Equate(R) Glycohemoglobin 3 Minute Test KitLCP · Traditional | Binax, Inc. | 10/31/1991SE |
| K905709 | Beckman Diatrac Hemoglobin a Electrophoresis KitLCP · Traditional | Beckman Instruments, Inc. | 09/23/1991SE |
| K911625 | Ames Dca 2000TM Analyzer and Reagent SystemLCP · Traditional | Heraeus Kulzer, Inc. | 09/05/1991SE |
| K904027 | Abbott Vision(Tm) Glycated HBLCP · Traditional | Abbott Laboratories | 02/07/1991SE |
| K905513 | Glyc-Affin(Tm)-GaLCP · Traditional | Isolab, Inc. | 01/15/1991SE |
| K904814 | Glyc-Affin GPLCP · Traditional | Isolab, Inc. | 12/26/1990SE |
| K896830 | Optimate Hemoglobin A1CLCP · Traditional | Heraeus Kulzer, Inc. | 09/11/1990SE |
| K902457 | Abnormal Glycohemoglobin ControlLCP · Traditional | Analytical Control Systems, Inc. | 07/24/1990SE |
| K902455 | Acs Normal Glycohemoglobin Control (A1C HGB)LCP · Traditional | Analytical Control Systems, Inc. | 07/24/1990SE |
| K896582 | Diabetes Care(Tm) Test Package for the CLC 330(TM)LCP · Traditional | Primus, Inc. | 06/28/1990SE |
| K901414 | Columnmate (Automated Column System) 1580, 1581LCP · Traditional | Helena Laboratories | 06/15/1990SE |
| K900718 | Rotag Fructosamine (Glycated Protein) AssayLCP · Traditional | Roche Diagnostic Systems, Inc. | 06/12/1990SE |
| K896335 | CLP Glycosylated Hemoglobin Control-NrLCP · Traditional | Creative Laboratory Products, Inc. | 12/11/1989SE |
| K896334 | CLP Glycosylated Hemoglobin Control-ErLCP · Traditional | Creative Laboratory Products, Inc. | 12/11/1989SE |
| K895661 | Glycotest II Glyhb Assay KitLCP · Traditional | Pierce Chemical Co. | 12/07/1989SE |
| K893453 | GlycabenLCP · Traditional | Exocell, Inc. | 10/23/1989SE |
| K893224 | Rep GLYCO-8 Kit, #3208/REP GLYCO-16 Kit, #3207LCP · Traditional | Helena Laboratories | 06/20/1989SE |
| K891235 | Primus Model CLC 330LCP · Traditional | Primus, Inc. | 06/16/1989SE |
| K884184 | Sigma Procedure No. 465 for Deter. of FructosamineLCP · Traditional | Sigma Diagnostics, Inc. | 03/28/1989SE |
| K884315 | Labile Lysing ReagentLCP · Traditional | Helena Laboratories | 12/27/1988SE |
| K880673 | GHB Sample PaperLCP · Traditional | Isolab, Inc. | 11/22/1988SE |
| K881863 | Rep Glyco SystemLCP · Traditional | Helena Laboratories | 09/30/1988SE |
| K874749 | Binax Equate GlycohemoglobinLCP · Traditional | Binax, Inc. | 08/12/1988SE |
| K882222 | Determin Hemoglobin Alc/Hi Perf Liq ChromatographyLCP · Traditional | Bio-Rad | 08/01/1988SE |
| K882051 | Bio-Rad Hemoglobin DetectorLCP · Traditional | Bio-Rad | 08/01/1988SE |
| K880698 | Titan Gel-Pc Glyco-Heme(Tm) SystemLCP · Traditional | Helena Laboratories | 05/06/1988SE |
| K873428 | Glyco-Probe GSPLCP · Traditional | Isolab, Inc. | 04/05/1988SE |
| K875354 | Unistep Capillary Blood Collection SystemLCP · Traditional | Ulster Scientific, Inc. | 02/17/1988SE |
| K854010 | Fructosamine Test (Roche)LCP · Traditional | Roche Diagnostic Systems, Inc. | 12/22/1987SE |
| K872852 | Eagle Diagnostics Glycohemoglobin Unitized TestLCP · Traditional | Sandare Chemical Co., Inc. | 09/29/1987SE |
| K871679 | Focus-GhbLCP · Traditional | Awareness Technology, Inc. | 07/28/1987SE |
| K871388 | Micromat Model 415 - Bichromatic Filter PhotometerLCP · Traditional | Bio-Rad | 07/06/1987SE |
| K864643 | Glycoscreen Glycosylated Hemoglobin Assay KitLCP · Traditional | Pacific Hemostasis | 04/28/1987SE |
| K862371 | Hemoglobin A1C by Column Test (Micro A1C)LCP · Traditional | Bio-Rad | 09/16/1986SE |
| K861697 | Self Assure/Ghb (Capillary-Blood Collection Kit)LCP · Traditional | Awareness Technology, Inc. | 08/19/1986SE |
| K862556 | Sandare Glycohemoglobin ProcedureLCP · Traditional | Sandare Chemical Co., Inc. | 08/08/1986SE |
| K860572 | Glycohemoglobin, In-Vitro Diagnostic Reagent SetLCP · Traditional | Pointe Scientific, Inc., | 05/16/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0732-2026 Class II | Diabetes HbA1c TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-1830-2025 Class II | ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-0223-2025 Class II | A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device…The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and… | Polymer Technology Systems, Inc. dba PTS… | 09/18/2024Completed |
| Z-2736-2024 Class II | Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to… | Abbott Diagnostics Technologies AS | 06/17/2024Open, Classified |
| Z-1304-2024 Class II | DCA Systems HbA1c Reagent KitThe reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias… | Siemens Healthcare Diagnostics, Inc. | 02/07/2024Open, Classified |
| Z-0930-2022 Class II | Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality… | Siemens Healthcare Diagnostics, Inc. | 02/09/2022Open, Classified |
| Z-2747-2020 Class II | DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW…If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the… | Siemens Healthcare Diagnostics, Inc. | 06/30/2020Terminated |
| Z-2281-2020 Class II | Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number…The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference… | Siemens Healthcare Diagnostics, Inc. | 05/04/2020Terminated |
| Z-2280-2020 Class II | ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI…The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference… | Siemens Healthcare Diagnostics, Inc. | 05/04/2020Terminated |
| Z-0601-2019 Class III | Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor…Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days… | Tosoh Bioscience Inc | 10/05/2018Terminated |
| Z-3244-2018 Class II | G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the…Analyzers were distributed with software which lacks a 510K | Tosoh Bioscience Inc | 07/13/2018Terminated |
| Z-2745-2018 Class II | G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product…HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers… | Tosoh Bioscience Inc | 06/06/2018Terminated |
| Z-1809-2018 Class II | Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In…The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-0285-2018 Class II | Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX…Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may… | Randox Laboratories Ltd. | 06/07/2017Terminated |
| Z-0686-2020 Class II | CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… | Polymer Technology Systems | 12/02/2016Terminated |
| Z-0685-2020 Class II | ReliOn FastA1C Test, Software Version Revision D, REF Number 3055A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… | Polymer Technology Systems | 12/02/2016Terminated |
| Z-0684-2020 Class II | Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… | Polymer Technology Systems | 12/02/2016Terminated |
| Z-0683-2020 Class II | A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… | Polymer Technology Systems | 12/02/2016Terminated |
| Z-0682-2020 Class II | A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US:…A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… | Polymer Technology Systems | 12/02/2016Terminated |
| Z-0395-2017 Class II | Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 /…Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin… | Roche Diagnostics Operations, Inc. | 10/04/2016Terminated |
| Z-2704-2016 Class II | ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry…Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test… | Siemens Healthcare Diagnostics, Inc. | 07/20/2016Terminated |
| Z-0695-2016 Class II | D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated…On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running… | Bio-Rad Laboratories, Inc. | 12/15/2015Terminated |
| Z-0340-2016 Class II | ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650…Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging… | Siemens Healthcare Diagnostics, Inc. | 09/24/2015Terminated |
| Z-2066-2015 Class III | G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin…The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015.… | Tosoh Bioscience, Inc. | 02/10/2015Terminated |
| Z-0420-2015 Class II | Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex…Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and… | Siemens Healthcare Diagnostics, Inc. | 09/30/2014Terminated |
| Z-0127-2015 Class II | Dimension Vista HbA1cIn March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery… | Siemens Healthcare Diagnostics, Inc. | 08/14/2014Terminated |
| Z-1299-2014 Class II | D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad…On a rare occasion the D-10 software might generate an extra result by duplicating the result form the… | Bio-Rad Laboratories, Inc. | 02/27/2014Terminated |
| Z-0965-2014 Class III | D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States…D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being… | Bio-Rad Laboratories, Inc. | 11/22/2013Terminated |
| Z-0136-2014 Class II | Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610)…Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits… | Bayer Healthcare Llc | 08/26/2013Terminated |
| Z-2135-2013 Class II | ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME:…Siemens confirmed that the ADVIA Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for… | Siemens Healthcare Diagnostics | 07/30/2013Terminated |
| Z-0626-2014 Class II | HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the…Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range"… | Siemens Healthcare Diagnostics, Inc. | 04/22/2013Terminated |
| Z-0625-2014 Class II | HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the…Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range"… | Siemens Healthcare Diagnostics, Inc. | 04/22/2013Terminated |
| Z-0027-2012 | VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-0026-2012 | VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. Made in United States. Bio-Rad…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-0025-2012 | VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. Made in United…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-0024-2012 | VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-0023-2012 | VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-0022-2012 | VARIANT II TURBO Hemoglobin A1c Program Buffer B, Made in United States. Bio-Rad…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-0021-2012 | VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-0020-2012 | VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-0019-2012 | D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547.…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-0018-2012 | D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547.…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-0017-2012 | D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | Bio-Rad Laboratories, Inc. | 09/12/2011Terminated |
| Z-3159-2011 | VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD.…The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle. | Bio-Rad Laboratories, Inc. | 07/28/2011Terminated |
| Z-2889-2011 | D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include…Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435. | Bio-Rad Laboratories Inc | 07/11/2011Terminated |
| Z-2170-2011 | Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number:…The recall was initiated because Beckman Coulter has identified a problem with two lots of HbA1c APT reagent… | Beckman Coulter Inc. | 03/01/2011Terminated |
| Z-0581-2012 | Principal Combo Test Pak, Product K8700, each kit packed in a bag or envelope and…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0580-2012 | Appraise DBS Test Pak/HW-Kronos KROJI, Product K8603, each kit packed in a bag or…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0578-2012 | Heritage Labs University of Michigan Clinical Kit, Product K8311, each kit packed in a…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0577-2012 | University of Mannheim DBS Collection Kit, Product K8308, each kit packed in a bag or…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |