# K123677: Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Mar 7, 2013 after 97 days
- Product code: JIF (Enzymatic Method, Ammonia)
- Device class: 1
- Regulation: 21 CFR 862.1065
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863840 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863840: Meth. & Cali. for the Dimension Clini/Chem. System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.
- K062334: Dimension Vista Chemistry 3 Calibrator, Model KC130, Dade Behring, Inc. (2006) Summary page 1.

## Recalls of this device
- Jun 29, 2017 · Class II · Z-1655-2018: 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 dep

## Indications for use
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.

Source page: https://510kreport.com/device/K123677
Methodology: https://510kreport.com/methodology