510(k) · Cleared
Recalled · Class II · 2017Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JIF Enzymatic Method, Ammonia
Cleared on Mar 7, 2013 as substantially equivalent to K863840 (E.I. Dupont DE Nemours & Co., Inc., 1986) and 1 other predicate after a 97-day review. Its family tree reaches back 1 generation to 1986. It has been recalled once.
- Decided
- Mar 7, 2013
- Review
- 97 days
- Class
- Class I
- Product code
- JIF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K863840 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK863840 Meth. & Cali. for the Dimension Clini/Chem. SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
- This deviceK123677 Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3…Siemens Healthcare Diagnostics · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863840 | Meth. & Cali. for the Dimension Clini/Chem. System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | — |
| 0 (this device) | K123677 | Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator… | Siemens Healthcare Diagnostics | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K863840 | Meth. & Cali. for the Dimension Clini/Chem. SystemSummary page 1…cate device used to demonstrate substantial equivalence to the Dimension ®Ammonia (AMM) Flex® reagent cartridge is the Dimension® Ammonia (AMON) previously cleared under k863840. The predicate device used to demonstrate substantial equivalence to the Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) is… | 1986 |
| * | K062334 | Dimension Vista Chemistry 3 Calibrator, Model KC130Summary page 1…substantial equivalence to the Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) is the Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) previously cleared under k062334. 7. Device Description: The Dimension Vista® Ammonia assay (AMM) is an enzymatic method that uses glutamate dleh… | 2006 |
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 |
|---|---|---|---|---|
| Jun 29, 2017 | Class II | Z-1655-2018 | Device Design | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results. |
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.
- 4 other devices also cite its predicate K863840.
How does its category compare?
All JIF devicesJIF Enzymatic Method, Ammonia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma (heparin or EDTA) on the Dimension Vista® System. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome
The CHEM 3 CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (C02) and Ethyl Alcohol (ETOR) methods on the Dimension Vista® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123677: Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123677
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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