LCP · Class II · 21 CFR 864.7470

FDA Product Code LCP: Assay, Glycosylated Hemoglobin

Leading manufacturers include Helena Laboratories, Bio-Rad and Abbott Laboratories.

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
1–24 of 249
Cleared Nov 22, 2024
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
K221326
Nova Biomedical Corporation
Chemistry · 931d
Cleared Dec 06, 2023
Q-Pad Test System
K231465
Qurasense
Chemistry · 201d
Cleared Sep 27, 2023
Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
K214117
Abbott Diagnostics Technologies AS
Chemistry · 636d
Cleared Mar 26, 2020
Aina HbA1c Monitoring System 2
K192987
Jana Care, Inc.
Chemistry · 153d
Cleared Oct 29, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K192369
Ixensor Co, Ltd.
Chemistry · 60d
Cleared Aug 15, 2019
OneDraw A1C Test System
K183230
Drawbridge Health, Inc.
Chemistry · 268d
Cleared Apr 12, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K181915
Ixensor Co, Ltd.
Chemistry · 269d
Cleared Feb 16, 2019
Quo-Test A1c System
K180509
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)
K173127
Skyla Corporation H.S.P.B
Chemistry · 361d
Cleared Feb 27, 2018
ACE Hemoglobin A1c (HbA1c) Reagent
K170623
Alfa Wassermann Diagnostic Technologies, LLC
Chemistry · 363d
Cleared Jul 14, 2014
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
K140829
Beckman Coulter, Inc.
Chemistry · 104d
Cleared Oct 12, 2012
GLYCOSYLATED HEMOGLOBIN ASSAY
K120199
Beckman Coulter, Inc.
Chemistry · 263d
Cleared Sep 11, 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
K121492
Beckman Coulter, Inc.
Chemistry · 113d
Cleared Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714
Roche Diagnostics Corp.
Chemistry · 206d
Cleared Sep 30, 2005
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
K052464
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Nov 17, 2004
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
K042459
Beckman Coulter, Inc.
Chemistry · 68d
Cleared Nov 15, 2001
DIMENSION HAIC ASSAY, MODEL DF105
K011852
Dade Behring, Inc.
Chemistry · 156d
Cleared Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
K010748
Beckman Coulter, Inc.
Hematology · 119d
Cleared Dec 19, 2000
VARIANT II TOTAL GHB
K003280
Bio-Rad
Hematology · 61d
Cleared Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120
Roche Diagnostics Corp.
Hematology · 74d
Cleared May 25, 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085
Abbott Laboratories
Hematology · 339d
Cleared Nov 01, 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483
Abbott Laboratories
Hematology · 187d
Cleared Sep 30, 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
K990992
Roche Diagnostics Corp.
Chemistry · 190d
Cleared Dec 17, 1998
VARIANT II HEMOGLOBIN A1C PROGRAM
K984268
Bio-Rad
Hematology · 17d

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 →