510(k) · Cleared
ClearedCalibrating Material, Ise Electrolyte Reference
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Diagnostics, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Nov 7, 2003 as substantially equivalent to K942676 (Beckman-Diagnostic Systems Group, 1994) and 1 other predicate after a 39-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Nov 7, 2003
- Review
- 39 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864236 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK864236 Synchron CX3Beckman Instruments, Inc. · 1986
- This deviceK033061 Calibrating Material, Ise Electrolyte ReferenceDiamond Diagnostics, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864236 | Synchron CX3 | Beckman Instruments, Inc. | 1986 | — |
| 0 (this device) | K033061 | Calibrating Material, Ise Electrolyte Reference | Diamond Diagnostics, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (2)
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 |
|---|---|---|---|
| * | K942676 | Synchron CX3 DeltaSummary page 1…BK-450214D ISE Electrolyte Reference 450214 ISE Electrolyte Reference 0 The predicate reagents are encompassed in the 51O(k)’s K942676 & K864236 cleared 11/02/1994 & 12/31/1986 respectively. 4. Device Description: 0 The Calibrato… | 1994 |
| * | K864236 | Synchron CX3Summary page 1…BK-450214D ISE Electrolyte Reference 450214 ISE Electrolyte Reference 0 The predicate reagents are encompassed in the 51O(k)’s K942676 & K864236 cleared 11/02/1994 & 12/31/1986 respectively. 4. Device Description: 0 The Calibrators for the… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K942676.
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 three products encompassed by this request are intended for in-vitro diagnostics use. Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta’s only) and TC02. When used in conjunction with C02 Acid Reagent, COSAlkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta’s only) and C02. The C02 Acid reagent…
Read the full statement (122 words)
The three products encompassed by this request are intended for in-vitro diagnostics use.
Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta’s only) and TC02. When used in conjunction with C02 Acid Reagent, COSAlkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta’s only) and C02.
The C02 Acid reagent is used to release C02 from samples
The C02 Alkaline in used to provide a constant C02 concentration as reference for the C02 electrode.
Mission reagents are intended to serve as direct replacements to the predicate devices manufactured by the OEM.
The products encompassed are to be handled using normal laboratory precautions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033061: Calibrating Material, Ise Electrolyte Reference.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033061
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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