CGA · Class II · 21 CFR 862.1345

FDA Product Code CGA: Glucose Oxidase, Glucose

Leading manufacturers include Boehringer Mannheim Corp., Instrumentation Laboratory CO and Abbott Point of Care, Inc..

401
Total
401
Cleared
129d
Avg days
1976
Since
Declining activity - 3 submissions in the last 2 years vs 5 in the prior period
Review times increasing: avg 817d recently vs 124d historically

FDA 510(k) Cleared Glucose Oxidase, Glucose Devices (Product Code CGA)

401 devices
1–24 of 401
Cleared May 01, 2026
ABL90 FLEX PLUS System
K252488
Radiometer Medicals Aps
Chemistry · 266d
Cleared Sep 30, 2024
YSI 2900C Biochemistry Analyzer
K210933
Ysi, Inc.
Chemistry · 1281d
Cleared Jul 26, 2024
EasyStat 300
K220328
Medica Corporation
Chemistry · 903d
Cleared Sep 20, 2023
Cholestech LDX ™ System
K223179
Alere San Diego, Inc.
Chemistry · 344d
Cleared Sep 11, 2023
i-STAT G cartridge with the i-STAT 1 System
K223755
Abbott Point of Care, Inc.
Chemistry · 270d
Cleared Jul 28, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710
Abbott Point of Care, Inc.
Chemistry · 228d
Cleared Jan 27, 2023
GEM Premier ChemSTAT
K223090
Instrumentation Laboratory CO
Chemistry · 119d
Cleared Oct 18, 2022
Nova Primary Glucose Analyzer System
K203549
Nova Biomedical Corporation
Chemistry · 683d
Cleared Aug 13, 2021
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K210958
Abbott Point of Care, Inc.
Chemistry · 135d
Cleared Mar 13, 2020
Stat Profile Prime Plus Analyzer System
K200349
Nova Biomedical Corporation
Chemistry · 30d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183678
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Apr 03, 2019
VITROS XT Chemistry Products GLU-Ca Slides
K190520
Ortho-Clinical Diagnostics, Inc.
Chemistry · 30d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183546
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Dec 21, 2018
PTS Professional Chemistry Kit
K182781
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
Chemistry · 81d
Cleared Sep 26, 2018
Stat Profile Prime Plus Analyzer System
K180340
Nova Biomedical Corporation
Chemistry · 231d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160402
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Sep 14, 2016
GEM Premier 3000
K161818
Instrumentation Laboratory CO
Chemistry · 75d
Cleared Apr 27, 2011
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
K103842
Beckman Coulter, Inc.
Chemistry · 118d
Cleared Oct 21, 2005
GEM PREMIER 3000
K052121
Instrumentation Laboratory CO
Chemistry · 77d
Cleared Sep 10, 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
K022158
Instrumentation Laboratory CO
Chemistry · 70d
Cleared Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
K014139
Roche Diagnostics Corp.
Chemistry · 94d
Cleared May 07, 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520
Instrumentation Laboratory CO
Chemistry · 74d
Cleared Sep 05, 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907
Roche Diagnostics Corp.
Chemistry · 75d
Cleared Feb 23, 2000
ACCU-CHEK ADVANTAGE METER
K000365
Roche Diagnostics Corp.
Chemistry · 19d

About Product Code CGA - Regulatory Context

510(k) Submission Activity

401 total 510(k) submissions under product code CGA since 1976, with 401 receiving FDA clearance (average review time: 129 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.

FDA 510(k) Review Time - CGA Product Code

Recent submissions under CGA have taken an average of 817 days to reach a decision - up from 124 days historically. Manufacturers should account for longer review timelines in current project planning.

CGA devices are reviewed by the Chemistry panel. Browse all Chemistry devices →