# K013451: Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 Series

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Diagnostics, Inc.
- Decided: Dec 18, 2001 after 61 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) Roche Diagnostics ISE Reagents for Roche Hitachi 700/900 series: named in the summary without a submission number

## Indications for use
The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Na*, K*, and CI" for the Roche Hitachi 700/900 Series Clinical Chemistry Systems. The ISE Diluent are 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 Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na, K* and CI' in serum samples on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Na', K* and CI” Electrodes on the Roche Hitachi ISE system.

Source page: https://510kreport.com/device/K013451
Methodology: https://510kreport.com/methodology