510(k) · Cleared
ClearedModification to: Diazyme Potassium Enzymatic Assay, Model DZ113A
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 Feb 15, 2006 after a 55-day review. The FDA summary names no predicate by number.
- Decided
- Feb 15, 2006
- Review
- 55 days
- Class
- Class II
- Product code
- MZV
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 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?
The FDA summary names no predicate by 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.
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.
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?
Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative in vitro determination of potassium in human serum. Measurements obtained by this assay are used to monitor electrolyte balance.
Diazyme Potassium Enzymatic Assay has controls for normal serum potassium level and abnormal serum potassium level. The controls are used as reference samples for checking the functionality of the Diazyme Potassium Enzymatic Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053566: Modification to: Diazyme Potassium Enzymatic Assay, Model DZ113A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053566
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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