FDA Product Code JGS: Electrode, Ion Specific, Sodium
Leading manufacturers include Instrumentation Laboratory CO, Beckman Coulter, Inc. and Nova Biomedical Corporation.
162
Total
162
Cleared
95d
Avg days
1977
Since
Declining activity -
1 submissions in the last 2 years
vs 3 in the prior period
Review times increasing: avg
267d
recently vs 94d historically
FDA 510(k) Cleared Electrode, Ion Specific, Sodium Devices (Product Code JGS)
162 devices
Cleared
May 01, 2026
ABL90 FLEX PLUS System
Radiometer Medicals Aps
Chemistry
267d
Cleared
Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Chemistry
268d
Cleared
Jul 25, 2023
A-LYTE® Integrated Multisensor (IMT Na K Cl)
Siemens Healthcare Diagnostics, Inc.
Chemistry
347d
Cleared
Jul 20, 2023
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Chemistry
472d
Cleared
Mar 10, 2022
GLP systems Track
Abbott Laboratories
Chemistry
132d
Cleared
Apr 14, 2020
Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation
Chemistry
55d
Cleared
Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Chemistry
406d
Cleared
Jul 19, 2019
Stat Profile Prime ES Comp Plus Analyzer System
Nova Biomedical Corporation
Chemistry
58d
Cleared
Jun 12, 2019
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
Ams Diagnostics
Chemistry
687d
Cleared
Feb 16, 2019
GEM Premier ChemSTAT
Instrumentation Laboratory CO
Chemistry
58d
Cleared
Aug 15, 2018
Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation
Chemistry
180d
Cleared
Jul 10, 2018
Synermed ISE Reagents
Infrared Laboratory Systems, LLC (Dba Synermed)
Chemistry
64d
Cleared
Feb 27, 2018
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
Awareness Technology, Inc.
Chemistry
284d
Cleared
Mar 09, 2017
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
Siemens Healthcare Diagnostics
Chemistry
234d
Cleared
Dec 16, 2016
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
Beckman Coulter, Inc.
Chemistry
164d
Cleared
Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
Instrumentation Laboratory CO
Chemistry
320d
Cleared
Dec 14, 2005
ISE INDIRECT NA, K, CL FOR GEN.2
Roche Diagnostics Corp.
Chemistry
30d
Cleared
Oct 04, 2002
SYNCHRON LX I 725 CLINICAL SYSTEM
Beckman Coulter, Inc.
Chemistry
22d
Cleared
May 16, 2001
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
Beckman Coulter, Inc.
Chemistry
26d
Cleared
Oct 24, 1996
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
Roche Diagnostic Systems, Inc.
Chemistry
43d
Cleared
Nov 06, 1992
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
Eastman Kodak Company
Chemistry
65d
Cleared
Jul 17, 1991
ISE/NA+
Boehringer Mannheim Corp.
Chemistry
30d
Cleared
Jun 10, 1991
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
Instrumentation Laboratory CO
Chemistry
38d
Cleared
Mar 06, 1991
CLINAK(TM) ISE SUBSYSTEM
Baxter Healthcare Corp
Chemistry
34d
About Product Code JGS - Regulatory Context
510(k) Submission Activity
162 total 510(k) submissions under product code JGS since 1977, with 162 receiving FDA clearance (average review time: 95 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - JGS Product Code
Recent submissions under JGS have taken an average of 267 days to reach a decision - up from 94 days historically. Manufacturers should account for longer review timelines in current project planning.
JGS devices are reviewed by the Chemistry panel. Browse all Chemistry devices →