510(k) · Cleared
ClearedAmmonia II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Operations (Rdo) · JIF Enzymatic Method, Ammonia
Cleared on Feb 8, 2019 as substantially equivalent to K003196 (Beckman Coulter, Inc., 2000) after a 52-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Feb 8, 2019
- Review
- 52 days
- Class
- Class I
- Product code
- JIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003196 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK003196 Synchron Systems Ammonia ReagentBeckman Coulter, Inc. · 2000
- This deviceK183517 Ammonia IIRoche Diagnostics Operations (Rdo) · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003196 | Synchron Systems Ammonia Reagent | Beckman Coulter, Inc. | 2000 | — |
| 0 (this device) | K183517 | Ammonia II | Roche Diagnostics Operations (Rdo) | 2019 | — |
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? (1)
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 |
|---|---|---|---|
| * | K003196 | Synchron Systems Ammonia ReagentSummary page 5…termined by measuring the decrease in absorbance. The following tables compare the Ammonia II (NH3L2) assay with its predicate device, SYNCHRON Systems Ammonia Reagent (k003196). Table 1: Assay Comparison SYNCHRON Systems Feature… | 2000 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All JIF devicesJIF Enzymatic Method, Ammonia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 II assay is an enzymatic in vitro test for the quantitative determination of ammonia in human plasma on Roche/Hitachi cobas c systems.
Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183517: Ammonia II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183517
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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