FDA Product Code LCP: Assay, Glycosylated Hemoglobin
Leading manufacturers include Helena Laboratories, Bio-Rad and Bio-Rad Laboratories, Inc..
249
Total
249
Cleared
146d
Avg days
1978
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
931d
recently vs 143d historically
FDA 510(k) Cleared Assay, Glycosylated Hemoglobin Devices (Product Code LCP)
249 devices
Cleared
Nov 22, 2024
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
Nova Biomedical Corporation
Chemistry
931d
Cleared
Dec 06, 2023
Q-Pad Test System
Qurasense
Chemistry
201d
Cleared
Sep 27, 2023
Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
Abbott Diagnostics Technologies AS
Chemistry
636d
Cleared
Mar 26, 2020
Aina HbA1c Monitoring System 2
Jana Care, Inc.
Chemistry
153d
Cleared
Oct 29, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
Ixensor Co, Ltd.
Chemistry
60d
Cleared
Aug 15, 2019
OneDraw A1C Test System
Drawbridge Health, Inc.
Chemistry
268d
Cleared
Apr 12, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
Ixensor Co, Ltd.
Chemistry
269d
Cleared
Feb 16, 2019
Quo-Test A1c System
Ekf Diagnostic GmbH
Chemistry
354d
Cleared
Sep 25, 2018
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
Skyla Corporation H.S.P.B
Chemistry
361d
Cleared
Feb 27, 2018
ACE Hemoglobin A1c (HbA1c) Reagent
Alfa Wassermann Diagnostic Technologies, LLC
Chemistry
363d
Cleared
Nov 21, 2016
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
Diazyme Laboratories
Chemistry
245d
Cleared
Jan 29, 2016
URight Hemoglobin A1c system, FORA A1c System
Taidoc Technology Corporation
Chemistry
498d
Cleared
Aug 06, 2014
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
Diazyme Laboratories
Chemistry
233d
Cleared
Jul 14, 2014
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
Beckman Coulter, Inc.
Chemistry
104d
Cleared
Jun 25, 2014
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
Bio-Rad Laboratories, Inc.
Chemistry
86d
Cleared
Jan 24, 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
Siemens Healthcare Diagnostics, Inc.
Chemistry
262d
Cleared
Oct 12, 2012
GLYCOSYLATED HEMOGLOBIN ASSAY
Beckman Coulter, Inc.
Chemistry
263d
Cleared
Sep 11, 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
Beckman Coulter, Inc.
Chemistry
113d
Cleared
May 14, 2012
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
Medica Corp.
Chemistry
83d
Cleared
Dec 23, 2011
TINA-QUANT HBA1C GEN.2
Roche Diagnostics
Chemistry
324d
Cleared
Aug 25, 2011
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
Siemens Healthcare Diagnostics
Chemistry
143d
Cleared
May 17, 2011
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
Diazyme Laboratories
Chemistry
113d
Cleared
May 13, 2011
DIMENSIONS HB1C KIT, MODEL DF105A
Siemens Healthcare Diagnostics
Chemistry
259d
Cleared
Jul 27, 2009
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
Bio-Rad Laboratories, Inc.
Chemistry
132d
About Product Code LCP - Regulatory Context
510(k) Submission Activity
249 total 510(k) submissions under product code LCP since 1978, with 249 receiving FDA clearance (average review time: 146 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - LCP Product Code
Recent submissions under LCP have taken an average of 931 days to reach a decision - up from 143 days historically. Manufacturers should account for longer review timelines in current project planning.
LCP devices are reviewed by the Hematology panel. Browse all Hematology devices →