Product code LCP— Hematology
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
- Classification name
- Assay, Glycosylated Hemoglobin
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Total cleared
- 249
- First cleared
- Most recent
Market context for product code LCP
FDA has cleared devices under product code LCP between 1978 and 2024, filed by 118 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2023
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
Top applicants under product code LCP
Recent clearances under product code LCP
1–100 of 249- K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer
- K231465 — Q-Pad Test System
- K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
- K192987 — Aina HbA1c Monitoring System 2
- K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
- K183230 — OneDraw A1C Test System
- K181915 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
- K180509 — Quo-Test A1c System
- K173127 — skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
- K170623 — ACE Hemoglobin A1c (HbA1c) Reagent
- K171650 — Alere Afinion HbA1c and ACR on Afinion 2 analyzer
- K170147 — Lucica Glycated Albumin-L
- K163633 — cobas HbA1c Test, cobas b 101 system
- K161533 — A1C EZ Glycohemoglobin Analysis System
- K162281 — CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
- K160762 — Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
- K142664 — URight Hemoglobin A1c system, FORA A1c System
- K140827 — SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
- K151809 — Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
- K141944 — HOME ACCESS AIC TEST
- K142789 — A1c iGear System
- K133803 — DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
- K141750 — HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
- K140829 — UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
- K140801 — VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
- K130014 — A1C GEAR SYSTEM
- K133344 — MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
- K131307 — ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
- K130990 — VARIANT(TM) II TURBO HBA1C KIT - 2.0
- K130860 — VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
- K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
- K122101 — CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
- K122472 — VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
- K120199 — GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
- K111128 — LABONACHECK A1C
- K121492 — UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
- K121366 — HEMOCUE HBA1C 501
- K113437 — ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT
- K120497 — EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
- K110313 — TINA-QUANT HBA1C GEN.2
- K112015 — PREMIER HB9210 HBA1C ANALYZER
- K110934 — ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
- K093548 — AVIE A1C TEST SYSTEM
- K100547 — ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
- K110188 — DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
- K102510 — DIMENSIONS HB1C KIT, MODEL DF105A
- K110056 — AFINION ANALYZER
- K102045 — DIMENSION VISA HBA1C, MODEL K3105A
- K102914 — TQ HBA1C GEN3
- K100304 — ST AIA PACK HBA1C
- K082275 — CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
- K091711 — S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
- K090699 — VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
- K091400 — MODIFICATION TO AVIE A1C TEST SYSTEM
- K090413 — A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
- K081269 — AVIE A1C TEST SYSTEM
- K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
- K073309 — ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
- K071132 — G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
- K080618 — DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
- K072714 — TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
- K072686 — AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
- K062658 — PRIMUS A1CARE ASSAY
- K071466 — DCA VANTAGE, MODEL 5075
- K070819 — VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
- K070452 — VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
- K063306 — ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
- K070734 — MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
- K063209 — HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
- K063643 — MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
- K063400 — VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
- K060650 — VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702
- K053411 — DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
- K060001 — D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
- K052464 — TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
- K051200 — HEMOGLOBIN A1C REAGENT SET
- K050574 — AFINION HBALC
- K050178 — HBA1C ENZYMATIC ASSAY
- K051321 — INVIEW
- K042459 — SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
- K042193 — DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
- K031296 — LIQUI-HEME GLYCO A1C ASSAY
- K041764 — THE VITROS 5,1 FS CHEMISTRY SYSTEM
- K041635 — G5 I HBA1C TEST, G5 II HBA1C TEST
- K041444 — BIO-RAD D-10 DUAL PROGRAM
- K040872 — VARIANT II HEMOGLOBIN A1C
- K033674 — MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
- K033847 — A1CNOW FOR HOME AND PROFESSIONAL USE
- K031380 — OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
- K031042 — ATAC HEMOGLOBIN A1C REAGENT KIT
- K030553 — ARKIT HBA1C
- K031043 — D-10 HEMOGLOBIN A1C
- K031539 — HEMOGLOBIN A1C REAGENT SET
- K023654 — GLYCA-DIRECT FRUCTOSAMINE
- K023763 — RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
- K022661 — A1CNOW FOR HOME USE
- K021897 — RANDOX HAEMOGLOBIN A1C
- K021484 — HEMOGLOBIN A1C CONTROL
- K020532 — POLYMEDCO HBA1C TEST
- K020234 — A1CNOW FOR RX HOME USE
Data sourced from openFDA. This site is unofficial and independent of the FDA.