JGS · Class II · 21 CFR 862.1665

FDA Product Code JGS: Electrode, Ion Specific, Sodium

Leading manufacturers include Nova Biomedical Corp., Medica Corp. and Instrumentation Laboratory CO.

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
1–24 of 162
Cleared May 01, 2026
ABL90 FLEX PLUS System
K252475
Radiometer Medicals Aps
Chemistry · 267d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230275
Abbott Point of Care, Inc.
Chemistry · 268d
Cleared Jul 25, 2023
A-LYTE® Integrated Multisensor (IMT Na K Cl)
K222438
Siemens Healthcare Diagnostics, Inc.
Chemistry · 347d
Cleared Jul 20, 2023
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
K220977
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Chemistry · 472d
Cleared Mar 10, 2022
GLP systems Track
K213486
Abbott Laboratories
Chemistry · 132d
Cleared Apr 14, 2020
Stat Profile Prime Plus Analyzer System
K200403
Nova Biomedical Corporation
Chemistry · 55d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Jul 19, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191365
Nova Biomedical Corporation
Chemistry · 58d
Cleared Jun 12, 2019
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
K172232
Ams Diagnostics
Chemistry · 687d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183549
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Aug 15, 2018
Stat Profile Prime Plus Analyzer System
K180428
Nova Biomedical Corporation
Chemistry · 180d
Cleared Jul 10, 2018
Synermed ISE Reagents
K181201
Infrared Laboratory Systems, LLC (Dba Synermed)
Chemistry · 64d
Cleared Feb 27, 2018
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
K171476
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)
K161954
Siemens Healthcare Diagnostics
Chemistry · 234d
Cleared Dec 16, 2016
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
K161837
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
K160225
Instrumentation Laboratory CO
Chemistry · 320d
Cleared Jun 09, 2016
BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
K160370
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Chemistry · 120d
Cleared Dec 11, 2015
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
K151767
Siemens Healthcare Diagnostics, Inc.
Chemistry · 164d
Cleared May 22, 2014
ISE INDIRECT NA, K, C1 FOR GEN 2
K140373
Roche Diagnostics
Chemistry · 97d
Cleared Dec 18, 2013
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
K132418
Roche Diagnostics
Chemistry · 138d
Cleared May 21, 2013
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
K123726
Roche Diagnostics
Chemistry · 168d
Cleared Jan 14, 2011
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
K100829
Medica Corp.
Chemistry · 296d
Cleared Apr 06, 2010
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
K100673
Medica Corp.
Chemistry · 28d
Cleared Sep 03, 2009
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
K091861
Ortho-Clinical Diagnostics, Inc.
Chemistry · 76d

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 →