Product code LCP

Device name: Assay, Glycosylated Hemoglobin
Medical specialty: Hematology
Device class: 2
Regulation number: 864.7470
Review panel: HE
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K221326	Nova Allegro HbA1c Assay, Nova Allegro Analyzer	Nova Biomedical Corporation	2024-11-22
K231465	Q-Pad Test System	Qurasense	2023-12-06
K214117	Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer	Abbott Diagnostics Technologies AS	2023-09-27
K192987	Aina HbA1c Monitoring System 2	Jana Care, Inc.	2020-03-26
K192369	PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit	Ixensor Co, Ltd.	2019-10-29
K183230	OneDraw A1C Test System	Drawbridge Health, Inc.	2019-08-15
K181915	PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit	Ixensor Co, Ltd.	2019-04-12
K180509	Quo-Test A1c System	Ekf-Diagnostic GmbH	2019-02-16
K173127	skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)	Skyla Corporation H.S.P.B	2018-09-25
K170623	ACE Hemoglobin A1c (HbA1c) Reagent	Alfa Wassermann Diagnostic Technologies, LLC	2018-02-27
K171650	Alere Afinion HbA1c and ACR on Afinion 2 analyzer	Abbott Rapid Diagnostics	2017-11-21
K170147	Lucica Glycated Albumin-L	Asahi Kasei Pharma Corporation	2017-10-12
K163633	cobas HbA1c Test, cobas b 101 system	Roche Diagnostics Operations	2017-07-28
K161533	A1C EZ Glycohemoglobin Analysis System	Biohermes Co., Ltd.	2017-06-16
K162281	CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)	Sebia	2017-02-17
K160762	Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set	Diazyme Laboratories	2016-11-21
K142664	URight Hemoglobin A1c system, FORA A1c System	Taidoc Technology Corporation	2016-01-29
K140827	SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set	Sd Biosensor, Inc.	2015-09-30
K151809	Alere Afinion HbA1c, Alere Afinion AS100 Analyzer	Alere Technologies AS	2015-09-25
K141944	HOME ACCESS AIC TEST	Home Access Health Corp.	2015-03-13
K142789	A1c iGear System	Sakae Corporation	2014-12-16
K133803	DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT	Diazyme Laboratories	2014-08-06
K141750	HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM	Infopia Co, Ltd.	2014-07-24
K140829	UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT	Beckman Coulter, Inc.	2014-07-14
K140801	VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM	Bio-Rad Laboratories, Inc.	2014-06-25
K130014	A1C GEAR SYSTEM	Sakae Corporation	2014-04-04
K133344	MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS	Sebia	2014-03-28
K131307	ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR	Siemens Healthcare Diagnostics, Inc.	2014-01-24
K130990	VARIANT(TM) II TURBO HBA1C KIT - 2.0	Bio-Rad Laboratories, Inc., Clinical Systems Divis	2013-05-09
K130860	VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE	Bio-Rad Laboratories, Inc., Clinical Systems Divis	2013-04-25

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00380740208639	Alinity	Abbott GmbH	2026-05-15
00380740208622	ARCHITECT	Abbott GmbH	2026-05-15
10304040178437	Henry Schein	HENRY SCHEIN, INC.	2024-01-12
00381933080018	A1CNow Self Check, 8ct.	POLYMER TECHNOLOGY SYSTEMS, INC.	2023-10-25
00021292015022	TRUE+ A1CNow Self Check	POLYMER TECHNOLOGY SYSTEMS, INC.	2023-07-30
07613336120927	Tina-quant Hemoglobin A1cDx Gen.3	Roche Diagnostics GmbH	2020-04-14
00380740135591	Alinity	Abbott GmbH	2019-04-08
15099590012120	AU	BECKMAN COULTER IRELAND INC.	2019-02-13
00628063401147	HbA1c Assay	SEKISUI DIAGNOSTICS, LLC	2018-09-24
00630414551364	DCA Vantage® Analyzer	Siemens Healthcare Diagnostics Inc.	2016-09-24
00842768032615	Dimension® Flex Reagent Cartridge HB1C	Siemens Healthcare Diagnostics Inc.	2016-09-24
00842768029974	Dimension Vista® Flex® reagent cartridge HbA1c KIT	Siemens Healthcare Diagnostics Inc.	2016-09-24
00847817002762	Hemoglobin Capillary Collection System (HCCS)	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817016035	D-100	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817016028	D-100	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817014871	VARIANT II TURBO Link	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817011979	VARIANT II Hemoglobin A1c	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817003462	D-10	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817003394	D-10 Dual	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817003356	D-10	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817002786	Hemoglobin Capillary Collection System (HCCS)	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817002731	Hemoglobin Capillary Collection System (HCCS)	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817000324	VARIANT II Hemoglobin A1c	BIO-RAD LABORATORIES, INC.	2016-09-12
00847817000096	D-10 Dual	BIO-RAD LABORATORIES, INC.	2016-09-12
00380740102746	ARCHITECT	Abbott GmbH	2016-09-09
00380740003609	ARCHITECT	ABBOTT LABORATORIES	2016-09-09
00380740003623	ARCHITECT	ABBOTT LABORATORIES	2016-09-09
00380740102722	ARCHITECT	Abbott GmbH	2016-09-09
00380740102739	ARCHITECT	Abbott GmbH	2016-09-09
00380740007843	ARCHITECT	Abbott GmbH	2016-06-06

Product code LCP

Related 510(k) Records#

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