# K020129: Phoenix Eletrolyte Calibration Set for the Roche Cobas Ise Module

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Diagnostics, Inc.
- Decided: Feb 1, 2002 after 18 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902675 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902675: Multi Analyte Mixture, Calibrators, Phoenix Diagnostics, Inc. (1990) Summary page 1.
- (no number) Roche Product 44224: named in the summary without a submission number

## Indications for use
The products encompassed by this request are intended for invitro diagnostic use and are intended for use in calibrating Na*, K, CI' electrodes in Roche Cobas ISE module. Roche is the original equipment manufacturer for the analyzer and predicate reagents. phoenix clectrolyte calibration set is intended for use in p of like named products manufactured by Roche Diagnostics.

Source page: https://510kreport.com/device/K020129
Methodology: https://510kreport.com/methodology