510(k) · Cleared
ClearedSodium Test Kit and Eletrolyte Cal 1 and 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · CEI Uranyl Acetate/Zinc Acetate, Sodium
Cleared on Feb 15, 2005 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 15, 2005
- Review
- 81 days
- Class
- Class II
- Product code
- CEI
- 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 CEI? 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?
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 CEI devicesCEI Uranyl Acetate/Zinc Acetate, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEI
FDA has decided no CEI device since 2007.
Median 510(k) review, days · CEI
Too few CEI 510(k)s in any year since 2007 to give a median.
Recalls per year · CEI
No recall names CEI since 2007.
Adverse event reports per year · CEI
No MAUDE report names CEI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 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?
Randox Laboratories Ltd. Sodium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Sodium in serum. Sodium is determined enzymatically via Sodium dependant a-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hyper-tension…
Read the full statement (157 words)
Randox Laboratories Ltd. Sodium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Sodium in serum. Sodium is determined enzymatically via Sodium dependant a-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration.
Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hyper-tension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
This Application Sheet has been developed for the Hitachi 704, 717, 902 and 911/912 Analysers and must be used by suitable qualified laboratory personnel under appropriate laboratory conditions.
Randox Electrolyte Cal 1 and 2 are liquid calibrators for in vitro diagnostic use in the calibration of NA+, K+ and CL- electrodes on Hitachi systems ISE modules and Randox Enzymatic Sodium kit.
The Randox Electrolyte Cal 1 and 2 must only be used by suitable qualified laboratory personnel under appropriate laboratory conditions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043268: Sodium Test Kit and Eletrolyte Cal 1 and 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043268
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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