510(k) · Cleared
Recalled · Class II · 2020Randox Ammonia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · JIF Enzymatic Method, Ammonia
Cleared on May 12, 2003 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.
- Decided
- May 12, 2003
- Review
- 53 days
- Class
- Class I
- Product code
- JIF
- Recalls
- 2
- 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 JIF? 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2020 | Class II | Z-2965-2020 | Under Investigation by firm | Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples. |
| Jul 30, 2020 | Class II | Z-2966-2020 | Under Investigation by firm | Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JIF devicesJIF Enzymatic Method, Ammonia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIF
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JIF
Too few JIF 510(k)s in any year since 2007 to give a median.
Recalls per year · JIF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIF
5in 2025
MAUDE reports naming product code JIF, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 1 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with a-ketoglutarate and NADPH in the presence of glutamate dehydrogenase (GLDH) to yield glutamate and NADP*. The corresponding decrease in absorbance at 340nm is proportional to the concentration of ammonia in the plasma. Ammonia measurememts are used in the diagnosis and treatment…
Read the full statement (103 words)
The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with a-ketoglutarate and NADPH in the presence of glutamate dehydrogenase (GLDH) to yield glutamate and NADP*. The corresponding decrease in absorbance at 340nm is proportional to the concentration of ammonia in the plasma.
Ammonia measurememts are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis and Reye's Syndrome.
This application sheet has been developed for the Advia 1650 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030873: Randox Ammonia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030873
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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