# K020148: pHoenix ISE Reagents FOR Olympus AU Chemistry Systems

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Diagnostics, Inc.
- Decided: Feb 4, 2002 after 19 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- 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) Olympus® ISE Buffer AU: named in the summary without a submission number
- (no number) Olympus® ISE Internal Reference Solution AU: named in the summary without a submission number
- (no number) Olympus® ISE Low Standard AU: named in the summary without a submission number
- (no number) Olympus® ISE High Standard AU: named in the summary without a submission number

## Indications for use
The pHoenix ISE Reagents for Olympus® AU Chemistry Systems are intended for use as ISE Reagents for the determination of Na®, K*, and CI' for the Olympus® AU Clinical Chemistry Systems. The ISE Buffer is intended for use as a diluent for patient samples for the quantitative determination of Na*, K" and CI in serum by ISE. The ISE Internal Reference Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na*, K" and CIin serum samples on the Olympus® AU Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Na®, K* and CI"Electrodes on the Olympus® AU ISE systems.

Source page: https://510kreport.com/device/K020148
Methodology: https://510kreport.com/methodology