JGS · Electrode, Ion Specific, Sodium
Clinical Chemistry · 21 CFR 862.1665 · Class 2
Overview
| Product Code | JGS |
|---|---|
| Device Name | Electrode, Ion Specific, Sodium |
| Regulation | 21 CFR 862.1665 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 161)
Showing 20 most recent of 161 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Oct 27, 2023 | SESE |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | Siemens Healthcare Diagnostics, Inc. | Jul 25, 2023 | SESE |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Jul 20, 2023 | SESE |
| K213486 | GLP systems Track | Abbott Laboratories | Mar 10, 2022 | SESE |
| K200403 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Apr 14, 2020 | SESE |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Feb 7, 2020 | SESE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | Jul 19, 2019 | SESE |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 | Ams Diagnostics | Jun 12, 2019 | SESE |
| K183549 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | Feb 16, 2019 | SESE |
| K180428 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Aug 15, 2018 | SESE |
| K181201 | Synermed ISE Reagents | Infrared Laboratory Systems, LLC (Dba Synermed) | Jul 10, 2018 | SESE |
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | Awareness Technology, Inc. | Feb 27, 2018 | SESE |
| K161954 | 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 | Mar 9, 2017 | SESE |
| K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer | Beckman Coulter, Inc. | Dec 16, 2016 | SESE |
| K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator | Instrumentation Laboratory CO | Dec 14, 2016 | SESE |
| K153357 | i-STAT Alinity System with i-STAT Sodium test | Abbott Point of Care, Inc. | Jul 8, 2016 | SESE |
| K160370 | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jun 9, 2016 | SESE |
| K151767 | 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 | Siemens Healthcare Diagnostics, Inc. | Dec 11, 2015 | SESE |
| K140373 | ISE INDIRECT NA, K, C1 FOR GEN 2 | Roche Diagnostics | May 22, 2014 | SESE |
| K132418 | COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 | Roche Diagnostics | Dec 18, 2013 | SESE |
Top Applicants
- Nova Biomedical Corp. — 18 clearances
- Medica Corp. — 9 clearances
- Instrumentation Laboratory CO — 5 clearances
- American Research Products Co. — 4 clearances
- Ciba Corning Diagnostics Corp. — 4 clearances
