510(k) · Cleared
Recalled · 2009Synchron Systems Ammonia (Amm) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JIF Enzymatic Method, Ammonia
Cleared on Jan 29, 1999 as substantially equivalent to K770363 (E.I. Dupont DE Nemours & Co., Inc., 1977) after a 51-day review. Its family tree reaches back 1 generation to 1977. It has been recalled once.
- Decided
- Jan 29, 1999
- Review
- 51 days
- Class
- Class I
- Product code
- JIF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K770363 (1977). No later device cites it as a predicate yet.
- Root · 1 generation backK770363 Aca Ammonia Analytical Test PackE.I. Dupont DE Nemours & Co., Inc. · 1977
- This deviceK984402 Synchron Systems Ammonia (Amm) ReagentBeckman Coulter, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770363 | Aca Ammonia Analytical Test Pack | E.I. Dupont DE Nemours & Co., Inc. | 1977 | — |
| 0 (this device) | K984402 | Synchron Systems Ammonia (Amm) Reagent | Beckman Coulter, Inc. | 1999 | — |
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 |
|---|---|---|---|
| * | K770363 | Aca Ammonia Analytical Test PackSummary page 1…Ammonia (21CFR §862.1065) / 4.0 Predicate Devicegs): SYNCHRON Systems Predicate Manufacturer Docket Reagent ‘Number SYNCHRON® Ammonia reagent on the { Dade Behring, Inc K770363 Systems Ammonia Dade aca®* clinical (AMM) analyzer *Trademark of Dade Behring Inc. — formerly DuPont 50 Description: The SYNCHRON… | 1977 |
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 |
|---|---|---|---|---|
| Mar 26, 2009 | Not classified | Z-1432-2012 | Unknown/Undetermined by firm | The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K770363.
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 SYNCHRON® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984402: Synchron Systems Ammonia (Amm) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984402
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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