# K023268: Phoenix Ise Standard a,B and C for Roche/Avl Systems

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Diagnostics, Inc.
- Decided: Nov 15, 2002 after 46 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 Standard A for AVL 982, 983, 985 (Cat. # BP0936): named in the summary without a submission number
- (no number) Roche Diagnostics Standard B for AVL 985 (Cat. # BP0937): named in the summary without a submission number
- (no number) Roche Diagnostics Standard C for AVL 985 (Cat. # BP0938): named in the summary without a submission number
- (no number) Roche Diagnostics Standard B for AVL 982, 983 (Cat. # BP0442): named in the summary without a submission number
- (no number) Roche Diagnostics Standard A for AVL 984, 987, 988 (Cat. # BP1232): named in the summary without a submission number
- (no number) Roche Diagnostics Standard B for AVL 984, 987, 988 (Cat. # BP1218): named in the summary without a submission number
- (no number) Roche Diagnostics Standard A for AVL 986 (Cat. # BP1203): named in the summary without a submission number
- (no number) Roche Diagnostics Standard B for AVL 986 (Cat. # BP1201): named in the summary without a submission number

## Most influential descendants
- K112834: Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit, Urine Uric Acid Standard Kit, Choles (2012), 0 descendants of its own

## Indications for use
The pHoenix ISE Standard for Roche AVL Instruments are intended for use as ISE Reagents for the determination of Na', K', Cl-, Ca'and Li' in human serum samples on the Roche AVL Systems. The standards are used for the calibration of the Roche AVL Instruments for the quantitative determination of Na', K' Cl-, Ca' and Li' in serum samples.

Source page: https://510kreport.com/device/K023268
Methodology: https://510kreport.com/methodology