# K020364: Phoenix Ise Reagents for Beckman CX Systems

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Diagnostics, Inc.
- Decided: Jun 4, 2002 after 120 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Beckman Coulter Electrolyte Buffer: named in the summary without a submission number
- (no number) Beckman Coulter Electrolyte Reference Reagent: named in the summary without a submission number
- (no number) Beckman Coulter CO2 Alkaline Buffer: named in the summary without a submission number
- (no number) Beckman Coulter CO2 Acid Reagent: named in the summary without a submission number
- (no number) Beckman Coulter Wash Concentrate: named in the summary without a submission number
- (no number) Beckman Coulter ISE Calibrator Level 1: named in the summary without a submission number
- (no number) Beckman Coulter ISE Calibrator Level 2: named in the summary without a submission number
- (no number) Beckman Coulter ISE Calibrator Level 3: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K020364
Methodology: https://510kreport.com/methodology