510(k) · Cleared
ClearedCalibrating Material, Calibrating Standards
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Diagnostics, Inc. · JIT Calibrator, Secondary
Cleared on Jun 25, 2003 as substantially equivalent to K963763 (Medica Corp., 1996) after a 72-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jun 25, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963763 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK963763 Easylyte Sodium/Potassium/Chloride/Lithium AnalyzerMedica Corp. · 1996
- This deviceK031159 Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963763 | Easylyte Sodium/Potassium/Chloride/Lithium Analyzer | Medica Corp. | 1996 | — |
| 0 (this device) | K031159 | Calibrating Material, Calibrating Standards | Diamond Diagnostics, Inc. | 2003 | — |
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 JIT? 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? (4)
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 |
|---|---|---|---|
| * | K963763 | Easylyte Sodium/Potassium/Chloride/Lithium AnalyzerSummary page 1…) 3. Predfcate Device: Mission claims substantial equivalence to the predicate device, Electrode, ion-specific,sodium; EasyLyte Na,K,CI, Li Analyzer; K963763, MEDICA CORP. 51O(k) Submission for Mission Dlagnostlcs Reag6ntS on Electrolyte Analyzers… | 1996 |
| * | — | Medica EasyLyte Solutions Pack Named without a submission number | |
| * | — | IL Test 800 Solutions Pack Named without a submission number | |
| * | — | Menarini Spotlyte 800 Solutions Pack Named without a submission number |
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?
- Its one ancestor has no recall.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes.
Mission reagents are intended to serve as direct replacements to like named products 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/K031159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031159: Calibrating Material, Calibrating Standards.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031159
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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