FDA 510(k) Applications for Medical Device Product Code "LCP"
(Assay, Glycosylated Hemoglobin)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991246 | A.P. TOTAL CARE, INC. | FRUCTOSAMINE, MODEL FR 106-01 | 12/16/1999 |
| K214117 | Abbott Diagnostics Technologies AS | AfinionÖ HbA1c, AfinionÖ 2 and Alere AfinionÖ AS100 Analyzer | 09/27/2023 |
| K991483 | ABBOTT LABORATORIES | ABBOTT ARCHITECT GLYCATED HEMOGLOBIN | 11/01/1999 |
| K992085 | ABBOTT LABORATORIES | ABBOTT IMX GLYCATED HEMOGLOBIN II | 05/25/2000 |
| K171650 | Abbott Rapid Diagnostics | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | 11/21/2017 |
| K151809 | Alere Technologies AS | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | 09/25/2015 |
| K113437 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT | 08/06/2012 |
| K091711 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 | 12/11/2009 |
| K170623 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC | ACE Hemoglobin A1c (HbA1c) Reagent | 02/27/2018 |
| K063306 | ALFA WASSERMANN, INC. | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 | 04/17/2007 |
| K030553 | ARKRAY, INC. | ARKIT HBA1C | 09/02/2003 |
| K170147 | ASAHI KASEI PHARMA CORPORATION | Lucica Glycated Albumin-L | 10/12/2017 |
| K121842 | AXIS-SHIELD DIAGNOSTICS, LTD. | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | 12/12/2012 |
| K072686 | AXIS-SHIELD DIAGNOSTICS, LTD. | AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS | 03/17/2008 |
| K110056 | AXIS-SHIELD POC AS | AFINION ANALYZER | 02/15/2011 |
| K050574 | AXIS-SHIELD POC AS | AFINION HBALC | 07/22/2005 |
| K955087 | BAYER CORP. | HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS | 06/13/1996 |
| K090413 | BAYER HEALTHCARE, LLC | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC | 05/14/2009 |
| K120199 | BECKMAN COULTER, INC | GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY | 10/12/2012 |
| K042459 | BECKMAN COULTER, INC. | SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT | 11/17/2004 |
| K010748 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT | 07/10/2001 |
| K140829 | BECKMAN COULTER, INC. | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT | 07/14/2014 |
| K121492 | BECKMAN COULTER, INC. | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT | 09/11/2012 |
| K973696 | BECKMAN INSTRUMENTS, INC. | SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT | 11/24/1997 |
| K984268 | BIO-RAD | VARIANT II HEMOGLOBIN A1C PROGRAM | 12/17/1998 |
| K003280 | BIO-RAD | VARIANT II TOTAL GHB | 12/19/2000 |
| K063643 | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI | MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM | 12/27/2006 |
| K070819 | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, | 06/25/2007 |
| K041444 | BIO-RAD LABORATORIES, INC. | BIO-RAD D-10 DUAL PROGRAM | 06/09/2004 |
| K031043 | BIO-RAD LABORATORIES, INC. | D-10 HEMOGLOBIN A1C | 08/27/2003 |
| K060001 | BIO-RAD LABORATORIES, INC. | D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM | 01/20/2006 |
| K040872 | BIO-RAD LABORATORIES, INC. | VARIANT II HEMOGLOBIN A1C | 04/15/2004 |
| K070452 | BIO-RAD LABORATORIES, INC. | VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU | 05/07/2007 |
| K090699 | BIO-RAD LABORATORIES, INC. | VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 | 07/27/2009 |
| K063400 | BIO-RAD LABORATORIES, INC. | VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 | 12/01/2006 |
| K140801 | BIO-RAD LABORATORIES, INC. | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | 06/25/2014 |
| K130860 | BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS | VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE | 04/25/2013 |
| K122472 | BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS | VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM | 10/26/2012 |
| K130990 | BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS | VARIANT(TM) II TURBO HBA1C KIT - 2.0 | 05/09/2013 |
| K031296 | BIODIAGNOSTIC INTL | LIQUI-HEME GLYCO A1C ASSAY | 10/15/2004 |
| K161533 | BioHermes Co., Ltd | A1C EZ Glycohemoglobin Analysis System | 06/16/2017 |
| K991850 | BIOSAFE LABORATORIES, INC. | SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC | 11/26/1999 |
| K974491 | BOEHRINGER MANNHEIM CORP. | ACCU-CHEK A1C HEMOGLOBIN TEST | 05/13/1998 |
| K021484 | CANTERBURY SCIENTIFIC LTD. | HEMOGLOBIN A1C CONTROL | 06/14/2002 |
| K111128 | CERAGEM INTERNATIONAL, INC. | LABONACHECK A1C | 09/13/2012 |
| K031042 | CLINICAL DATA, INC. | ATAC HEMOGLOBIN A1C REAGENT KIT | 11/03/2003 |
| K011852 | DADE BEHRING, INC. | DIMENSION HAIC ASSAY, MODEL DF105 | 11/15/2001 |
| K013465 | DIABETES TECHNOLOGIES, INC. | ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT | 01/22/2002 |
| K983172 | DIABETES TECHNOLOGIES, INC. (DTI) | ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT | 11/30/1998 |
| K160762 | DIAZYME LABORATORIES | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set | 11/21/2016 |
| K110188 | DIAZYME LABORATORIES | DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT | 05/17/2011 |
| K042193 | DIAZYME LABORATORIES | DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT | 10/29/2004 |
| K133803 | DIAZYME LABORATORIES | DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT | 08/06/2014 |
| K070734 | DIAZYME LABORATORIES | MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON | 04/09/2007 |
| K183230 | Drawbridge Health, Inc. | OneDraw A1C Test System | 08/15/2019 |
| K180509 | EKF-diagnostic GmbH | Quo-Test A1c System | 02/16/2019 |
| K980888 | EXOCELL, INC. | GLYCACOR | 08/13/1998 |
| K973365 | EXPRESS-MED, INC. | AIC - CHEK (HBAIC-I) | 06/15/1998 |
| K971919 | FLEXSITE DIAGNOSTICS, INC. | EZCHEK/HBA BLOOD COLLECTION KIT | 09/05/1997 |
| K050178 | GENERAL ATOMICS | HBA1C ENZYMATIC ASSAY | 06/28/2005 |
| K000239 | GENZYME CORP. | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL | 03/21/2000 |
| K983726 | GENZYME CORP. | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL | 11/25/1998 |
| K141944 | HOME ACCESS HEALTH CORP. | HOME ACCESS AIC TEST | 03/13/2015 |
| K073309 | HORIBA ABX | ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT | 10/17/2008 |
| K082275 | INFOPIA CO., LTD | CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 | 01/14/2010 |
| K121366 | INFOPIA CO., LTD | HEMOCUE HBA1C 501 | 09/07/2012 |
| K141750 | INFOPIA CO., LTD | HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM | 07/24/2014 |
| K192369 | iXensor Co. Ltd. | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | 10/29/2019 |
| K181915 | iXensor Co., LTD. | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | 04/12/2019 |
| K192987 | Jana Care, Inc | Aina HbA1c Monitoring System 2 | 03/26/2020 |
| K080618 | JAS Diagnostics, Inc. | DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID | 05/23/2008 |
| K962597 | LXN CORP. | LXN FRUCTOSAMINE TEST SYSTEM | 06/13/1997 |
| K081269 | MEC DYNAMICS CORP | AVIE A1C TEST SYSTEM | 03/20/2009 |
| K093548 | MEC DYNAMICS CORP | AVIE A1C TEST SYSTEM | 07/20/2011 |
| K091400 | MEC DYNAMICS CORP | MODIFICATION TO AVIE A1C TEST SYSTEM | 06/11/2009 |
| K120497 | MEDICA CORP. | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL | 05/14/2012 |
| K983253 | MEDISENSE, INC. | PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT | 11/20/1998 |
| K033847 | METRIKA, INC. | A1CNOW FOR HOME AND PROFESSIONAL USE | 12/23/2003 |
| K022661 | METRIKA, INC. | A1CNOW FOR HOME USE | 12/13/2002 |
| K020235 | METRIKA, INC. | A1CNOW FOR PROFESSIONAL USE | 02/15/2002 |
| K020234 | METRIKA, INC. | A1CNOW FOR RX HOME USE | 02/15/2002 |
| K000887 | METRIKA, INC. | DRX HBA1C | 07/26/2000 |
| K000885 | METRIKA, INC. | DRX HBA1C - FOR PRESCRIPTION HOME USE | 09/26/2000 |
| K051321 | METRIKA, INC. | INVIEW | 06/13/2005 |
| K053411 | MICROGENICS CORP. | DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS | 02/03/2006 |
| K963844 | MORAX | HYDRAGEL 15 HB A1C KIT | 04/22/1997 |
| K031380 | OLYMPUS AMERICA, INC. | OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) | 11/14/2003 |
| K041764 | ORTHO-CLINICAL DIAGNOSTICS | THE VITROS 5,1 FS CHEMISTRY SYSTEM | 09/09/2004 |
| K060650 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 | 04/06/2006 |
| K990899 | OSBORN GROUP, INC. | HEMOCHEK-A1C SAMPLE COLLECTION KIT | 12/21/1999 |
| K984529 | OSBORN LABORATORIES, INC. | HEMOCHEK SAMPLE COLLECTION KIT | 01/28/1999 |
| K993590 | POINTE SCIENTIFIC, INC. | FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET | 12/21/1999 |
| K031539 | POINTE SCIENTIFIC, INC. | HEMOGLOBIN A1C REAGENT SET | 08/06/2003 |
| K023654 | POLYMEDCO, INC. | GLYCA-DIRECT FRUCTOSAMINE | 05/02/2003 |
| K020532 | POLYMEDCO, INC. | POLYMEDCO HBA1C TEST | 04/24/2002 |
| K062658 | PRIMUS CORP. | PRIMUS A1CARE ASSAY | 11/26/2007 |
| K994045 | PRIMUS CORP. | PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 | 12/21/1999 |
| K992921 | PRIMUS CORP. | PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II | 11/12/1999 |
| K112015 | PRIMUS CORPORATION DBA TRINITY BIOTECH | PREMIER HB9210 HBA1C ANALYZER | 11/22/2011 |
| K993131 | PRIMUS, INC. | NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY | 05/22/2000 |
| K041635 | PROVALIS DIAGNOSTICS LTD. | G5 I HBA1C TEST, G5 II HBA1C TEST | 08/16/2004 |
| K001392 | PROVALIS DIAGNOSTICS LTD. | GLYCOSAL HBA1C TEST | 08/21/2000 |
| K011933 | PROVALIS DIAGNOSTICS LTD. | GLYCOSAL II HBA 1C TEST | 11/02/2001 |
| K023763 | RANDOX LABORATORIES, LTD. | RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS | 01/13/2003 |
| K021897 | RANDOX LABORATORIES, LTD. | RANDOX HAEMOGLOBIN A1C | 11/26/2002 |
| K102914 | ROCHE | TQ HBA1C GEN3 | 01/20/2011 |
| K952337 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P | 02/09/1996 |
| K961674 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE UNIMATE FRUCTOSAMINE REAGENT | 09/27/1996 |
| K110313 | Roche Diagnostics | TINA-QUANT HBA1C GEN.2 | 12/23/2011 |
| K990992 | ROCHE DIAGNOSTICS CORP. | INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC | 09/30/1999 |
| K003120 | ROCHE DIAGNOSTICS CORP. | MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C | 12/18/2000 |
| K052464 | ROCHE DIAGNOSTICS CORP. | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST | 09/30/2005 |
| K072714 | ROCHE DIAGNOSTICS CORP. | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM | 04/18/2008 |
| K163633 | Roche Diagnostics Operations | cobas HbA1c Test, cobas b 101 system | 07/28/2017 |
| K130014 | Sakae Corporation | A1C GEAR SYSTEM | 04/04/2014 |
| K142789 | Sakae Corporation | A1c iGear System | 12/16/2014 |
| K140827 | SD Biosensor, Inc. | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | 09/30/2015 |
| K162281 | SEBIA | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | 02/17/2017 |
| K122101 | SEBIA | CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C | 12/06/2012 |
| K133344 | SEBIA | MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS | 03/28/2014 |
| K100547 | SEPPIM S.A.S. | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL | 05/19/2011 |
| K033674 | SERADYN INC. | MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS | 02/09/2004 |
| K110934 | SIEMENS HEALTHCARE DIAGNOSTICS | ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY | 08/25/2011 |
| K102510 | SIEMENS HEALTHCARE DIAGNOSTICS | DIMENSIONS HB1C KIT, MODEL DF105A | 05/13/2011 |
| K131307 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR | 01/24/2014 |
| K102045 | SIEMENS HEATLHCARE DIAGNOSTICS INC | DIMENSION VISA HBA1C, MODEL K3105A | 02/14/2011 |
| K081895 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS | 01/08/2009 |
| K071466 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS | DCA VANTAGE, MODEL 5075 | 10/09/2007 |
| K012410 | SIGMA DIAGNOSTICS, INC. | INFINITY HBA KIT, MODELS 537-A, 537-B | 10/26/2001 |
| K173127 | Skyla Corporation H.S.P.B. | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) | 09/25/2018 |
| K142664 | TAIDOC TECHNOLOGY CORPORATION | URight Hemoglobin A1c system, FORA A1c System | 01/29/2016 |
| K051200 | TECO DIAGNOSTICS | HEMOGLOBIN A1C REAGENT SET | 08/08/2005 |
| K012525 | THERMO DMA, INC. | THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 | 10/04/2001 |
| K063209 | THERMO ELECTRON OY | HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL | 03/21/2007 |
| K071132 | Tosoh BioScience, Inc. | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 | 09/16/2008 |
| K100304 | Tosoh BioScience, Inc. | ST AIA PACK HBA1C | 08/27/2010 |
| K972265 | TOSOH MEDICS, INC. | A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER | 09/25/1997 |
| K011434 | TOSOH MEDICS, INC. | G7 AUTOMATED HPLC ANALYZER | 09/18/2001 |
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