510(k) · Cleared
ClearedPhoenix Ise Reagents for Beckman CX Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phoenix Diagnostics, Inc. · JGS Electrode, Ion Specific, Sodium
Cleared on Jun 4, 2002 after a 120-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 4, 2002
- Review
- 120 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Beckman Coulter Electrolyte Buffer Named without a submission number | |
| * | — | Beckman Coulter Electrolyte Reference Reagent Named without a submission number | |
| * | — | Beckman Coulter CO2 Alkaline Buffer Named without a submission number | |
| * | — | Beckman Coulter CO2 Acid Reagent Named without a submission number | |
| * | — | Beckman Coulter Wash Concentrate Named without a submission number | |
| * | — | Beckman Coulter ISE Calibrator Level 1 Named without a submission number | |
| * | — | Beckman Coulter ISE Calibrator Level 2 Named without a submission number | |
| * | — | Beckman Coulter ISE Calibrator Level 3 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The pHoenix ISE Reagents for Beckman CX Systems are intended for use as ISE Reagents for the determination of Na+, K+, Cl- and CO2 in human serum samples on the Beckman CX Systems. The Electrolyte Buffer is diluted with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, Cl- and CO2. The Electrolyte Reference Reagent is to provide reference points for Na+, K+, Cl- and CO2. The CO2 Acid Reagent is to…
Read the full statement (157 words)
The pHoenix ISE Reagents for Beckman CX Systems are intended for use as ISE Reagents for the determination of Na+, K+, Cl- and CO2 in human serum samples on the Beckman CX Systems.
The Electrolyte Buffer is diluted with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, Cl- and CO2.
The Electrolyte Reference Reagent is to provide reference points for Na+, K+, Cl- and CO2.
The CO2 Acid Reagent is to release CO2 from serum samples.
The CO2 Alkaline Buffer is to provide a constant CO2 concentration as reference for the CO2 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems.
The Calibrators are used for the calibration of the CX ISE Modules for the quantitative determination of Na+, K+ Cl- and CO2 in serum samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020364: Phoenix Ise Reagents for Beckman CX Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020364
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026