510(k) · Cleared
ClearedPhoenix Ise Standard a,B and C for Roche/Avl Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phoenix Diagnostics, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Nov 15, 2002 after a 46-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 15, 2002
- Review
- 46 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK023268 Phoenix Ise Standard a,B and C for Roche/Avl SystemsPhoenix Diagnostics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK112834 Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine…Verichem Laboratories, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K112834Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit…Verichem Laboratories, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023268 | Phoenix Ise Standard a,B and C for Roche/Avl Systems | Phoenix Diagnostics, Inc. | 2002 | — |
| +1 | K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand… | Verichem Laboratories, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Roche Diagnostics Standard A for AVL 982, 983, 985 (Cat. # BP0936) Named without a submission number | |
| * | — | Roche Diagnostics Standard B for AVL 985 (Cat. # BP0937) Named without a submission number | |
| * | — | Roche Diagnostics Standard C for AVL 985 (Cat. # BP0938) Named without a submission number | |
| * | — | Roche Diagnostics Standard B for AVL 982, 983 (Cat. # BP0442) Named without a submission number | |
| * | — | Roche Diagnostics Standard A for AVL 984, 987, 988 (Cat. # BP1232) Named without a submission number | |
| * | — | Roche Diagnostics Standard B for AVL 984, 987, 988 (Cat. # BP1218) Named without a submission number | |
| * | — | Roche Diagnostics Standard A for AVL 986 (Cat. # BP1203) Named without a submission number | |
| * | — | Roche Diagnostics Standard B for AVL 986 (Cat. # BP1201) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit… | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K112834 (Verichem Laboratories, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023268: Phoenix Ise Standard a,B and C for Roche/Avl Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023268
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026