510(k) · Cleared
Recalled · Class II · 2015Sentinel Ammonia Ultra Diagnostic Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentinel Ch. Srl · JIF Enzymatic Method, Ammonia
Cleared on Nov 25, 2005 as substantially equivalent to K974620 (Trace America, Inc., 1998) and 1 other predicate after a 207-day review. Its family tree reaches back 1 generation to 1991. It has been recalled once.
- Decided
- Nov 25, 2005
- Review
- 207 days
- Class
- Class I
- Product code
- JIF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913346 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK913346 Quantimetrix Ammonia ControlsQuantimetrix Corp. · 1991
- This deviceK051114 Sentinel Ammonia Ultra Diagnostic AssaySentinel Ch. Srl · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913346 | Quantimetrix Ammonia Controls | Quantimetrix Corp. | 1991 | — |
| 0 (this device) | K051114 | Sentinel Ammonia Ultra Diagnostic Assay | Sentinel Ch. Srl | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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 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? (2)
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 |
|---|---|---|---|
| * | K974620 | Ammonia-Incorporating Dynamic Stabilization Technology (DST)Summary page 2…cr eioFk'ancdt Incorporating TaeAeia 1 Ammonia Ultra Dynamic K974620 02 Jan. 1998 IncI s ~~~~~~ Stabilization… | 1998 |
| * | K913346 | Quantimetrix Ammonia ControlsSummary page 2…i Technology 2 Ammonia Controls Quantimetrix Quantimetrix K913346 25 Sep. 1991 Ammonia Controls Corp. Sentinel Ammonia Ultra… | 1991 |
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 |
|---|---|---|---|---|
| Sep 22, 2015 | Class II | Z-0164-2016 | Process control | Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
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 Ammonia Ultra is intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome
The Ammonia Controls are intended as a means of monitoring Sentinel Ammonia Ultra assay method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051114: Sentinel Ammonia Ultra Diagnostic Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051114
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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