510(k) · Cleared
ClearedDiazyme Liquid Stable Enzymatic Potassium Assay Kit, Model DZ113C-X, Diazyme Liquid Stable Enzymatic Potassium Assay Cal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · MZV Test, System, Potassium, Enzymatic Method
Cleared on Aug 14, 2009 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 14, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- MZV
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MZV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MZV device
- #1 K200865 Piccolo Potassium Test Systemscore 2.5 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MZV devicesMZV Test, System, Potassium, Enzymatic Method: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MZV
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MZV
Too few MZV 510(k)s in any year since 2007 to give a median.
Recalls per year · MZV
No recall names MZV since 2007.
Adverse event reports per year · MZV
1in 2015
MAUDE reports naming product code MZV, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 57 |
| 2012 | 0 | — | 0 | 32 |
| 2013 | 0 | — | 0 | 63 |
| 2014 | 0 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro quantitative determination of potassium in human serum. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. For IVD use only.
The Diazyme Liquid Stable Enzymatic Potassium Assay Calibrator Kit is intended for use in the calibration of quantitative Diazyme Liquid Stable Enzymatic Potassium Assay Kit (DZ1 13C). For IVD use only.
The Diazyme Liquid Stable Enzymatic Potassium Assay Control Kit is intended for use as quality controls for the Diazyme Liquid Stable Enzymatic Potassium Assay (DZ 113C). For IVD use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091455 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091455: Diazyme Liquid Stable Enzymatic Potassium Assay Kit, Model DZ113C-X, Diazyme Liquid Stable Enzymatic Potassium Assay Cal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091455
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026